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Clinical Trial Results:
Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension

Summary
EudraCT number	2015-003329-32
Trial protocol	Outside EU/EEA
Global end of trial date	15 Sep 2008

Results information
Results version number	v1(current)
This version publication date	20 Nov 2018
First version publication date	25 Nov 2016
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CS0866-A-U301

ISRCTN number

US NCT number

NCT00151775

WHO universal trial number (UTN)

Sponsor organisation name

Daiichi Sankyo Pharma Development

Sponsor organisation address

399 Thornall Street, Edison, New Jersey, United States, 08837

Public contact

Clinical Trial Information, Daiichi Sankyo Development Ltd, +44 1753482800, euregaffairs@dsd-eu.com

Scientific contact

Clinical Trial Information, Daiichi Sankyo Development Ltd, +44 1753482800, euregaffairs@dsd-eu.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

15 Sep 2008

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

15 Sep 2008

Was the trial ended prematurely?

Main objective of the trial

The main objective of this study was to evaluate the efficacy and safety of Olmesartan Medoxomil in subjects 6 to 16 years of age with high Blood Pressure or hypertension.

Protection of trial subjects

Subjects safety was assessed throughout the study by monitoring of adverse events (AEs) and routine laboratory safety tests, vital signs, and physical examination findings.

Background therapy

Evidence for comparator

Actual start date of recruitment

27 Apr 2005

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 162

Country: Number of subjects enrolled

India: 37

Country: Number of subjects enrolled

Argentina: 34

Country: Number of subjects enrolled

Chile: 7

Country: Number of subjects enrolled

Colombia: 19

Country: Number of subjects enrolled

Costa Rica: 6

Country: Number of subjects enrolled

South Africa: 82

Country: Number of subjects enrolled

Kenya: 2

Country: Number of subjects enrolled

Uganda: 8

Country: Number of subjects enrolled

Zambia: 5

Worldwide total number of subjects

362

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

158

Adolescents (12-17 years)

195

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 362 patients between 1 and 16 years of age were recruited on a global basis between 27 April 2005 and 15 September 2008.

Period 1 title

Period 1: Screening

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

All Patients

Arm description

Period 1 was a screening, wash-out period of approximately two weeks. All participants were included in the screening, wash-out period and during this period no intervention was administered.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 1	All Patients
Started	362
Completed	362

Period 2 title

Period 2: Double-blind, Dose Response

Is this the baseline period?

Yes ^[1]

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Cohort A: High Dose OM in Periods 2 and 3

Arm description

Patients in subgroup of Cohort A (6-16 years old with a limit on the number of Black patients) given a high dose of olmesartan medoxomil suspension (OM), depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received a high dose of olmesartan medoxomil, 20 mg orally once daily for patients weighing more than 20 kg and less than 35 kg, and 40 mg once daily for patients weighing 35 kg or more.

Cohort A: Low Dose OM in Periods 2 and 3

Arm description

Patients in subgroup of Cohort A (6-16 years old with a limit on the number of Black patients) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received a low dose of olmesartan medoxomil, 2.5 mg orally once daily for patients weighing more than 20 kg and less than 35 kg, and 40 mg once daily for patients weighing 35 kg or more.

Cohort B: High Dose OM in Periods 2 and 3

Arm description

Patients in subgroup of Cohort B (6-16 years old comprised exclusively of Black subjects) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the subjects continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received a high dose of olmesartan medoxomil, 20 mg orally once daily for patients weighing more than 20 kg and less than 35 kg, and 40 mg once daily for patients weighing 35 kg or more.

Cohort B: Low Dose OM in Periods 2 and 3

Arm description

Patients in subgroup of Cohort B (6-16 years old comprised exclusively of Black subjects) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the subjects continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received a low dose of olmesartan medoxomil, 2.5 mg orally once daily for patients weighing more than 20 kg and less than 35 kg, and 40 mg once daily for patients weighing 35 kg or more.

Cohort C: OM in Periods 2, 3, and 4

Arm description

Patients in subgroup of cohort C (1-5 years old) were given olmesartan medoxomil 0.3 mg/kg in Period 2 (open-label period from day 0 to week 3) and patients in a subgroup of Cohort C were given that dose of OM during Period 3 (double-blind, placebo controlled period from week 3 to week 5). In Period 4 (open-label period from weeks 6-51), all patients in Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two weeks, the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received olmesartan medoxomil suspension (OM), 0.3 mg/kg orally once daily for 3 weeks.

Notes
[1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
Justification: Period 1 is not the baseline period because it was a screening and wash-out period before randomization, so all subjects were included.

Number of subjects in period 2	Cohort A: High Dose OM in Periods 2 and 3	Cohort A: Low Dose OM in Periods 2 and 3	Cohort B: High Dose OM in Periods 2 and 3	Cohort B: Low Dose OM in Periods 2 and 3	Cohort C: OM in Periods 2, 3, and 4
Started	95	95	56	56	60
Completed	93	89	54	53	59
Not completed	2	6	2	3	1
Blood pressure goal was met	-	-	-	1	-
Physician decision	-	-	1	-	-
Adverse event, non-fatal	1	2	-	-	-
Unknown	-	-	-	1	-
Lost to follow-up	1	-	-	1	1
Protocol deviation	-	4	1	-	-

Period 3 title

Period 3: Double-blind, Withdrawal

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Cohort A: High Dose OM in Periods 2 and 3

Arm description

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received a high dose of olmesartan medoxomil, 20 mg orally once daily for patients weighing more than 20 kg and less than 35 kg, and 40 mg once daily for patients weighing 35 kg or more.

Cohort A: Low Dose OM in Periods 2 and 3

Arm description

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received a low dose of olmesartan medoxomil, 2.5 mg orally once daily for patients weighing more than 20 kg and less than 35 kg, and 40 mg once daily for patients weighing 35 kg or more.

Cohort B: High Dose OM in Periods 2 and 3

Arm description

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received a high dose of olmesartan medoxomil, 20 mg orally once daily for patients weighing more than 20 kg and less than 35 kg, and 40 mg once daily for patients weighing 35 kg or more.

Cohort B: Low Dose OM in Periods 2 and 3

Arm description

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received a low dose of olmesartan medoxomil, 2.5 mg orally once daily for patients weighing more than 20 kg and less than 35 kg, and 40 mg once daily for patients weighing 35 kg or more.

Cohort C: OM in Periods 2, 3, and 4

Arm description

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received olmesartan medoxomil suspension (OM), 0.3 mg/kg orally once daily for 3 weeks.

Cohort A: Placebo in Period 3 (From High Dose in Period 2)

Arm description

Patients in subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of OM.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received placebo orally once daily.

Cohort A: Placebo in Period 3 (From Low Dose in Period 2)

Arm description

Patients in subgroup of Cohort A (6-16 years old with a limit on the number of Black patients) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of OM.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received placebo orally once daily.

Cohort B: Placebo in Period 3 (From High Dose in Period 2)

Arm description

Patients in subgroup of Cohort B (6-16 years old comprised exclusively of Black patients), given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of OM.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received placebo orally once daily.

Cohort B: Placebo in Period 3 (From Low Dose in Period 2)

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received placebo orally once daily.

Cohort C: Placebo in Period 3 (From OM in Period 2)

Arm description

Patients in subgroup of Cohort C (1-5 years old), given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Patients received placebo orally once daily.

Number of subjects in period 3 ^[2]	Cohort A: High Dose OM in Periods 2 and 3	Cohort A: Low Dose OM in Periods 2 and 3	Cohort B: High Dose OM in Periods 2 and 3	Cohort B: Low Dose OM in Periods 2 and 3	Cohort C: OM in Periods 2, 3, and 4	Cohort A: Placebo in Period 3 (From High Dose in Period 2)	Cohort A: Placebo in Period 3 (From Low Dose in Period 2)	Cohort B: Placebo in Period 3 (From High Dose in Period 2)	Cohort B: Placebo in Period 3 (From Low Dose in Period 2)	Cohort C: Placebo in Period 3 (From OM in Period 2)
Started	48	45	26	27	29	45	44	28	26	29
Completed	48	45	25	26	29	42	44	27	26	28
Not completed	0	0	1	1	0	3	0	1	0	1
Consent withdrawn by subject	-	-	1	-	-	-	-	-	-	-
Adverse event, non-fatal	-	-	-	-	-	1	-	-	-	-
Met blood pressure goal	-	-	-	1	-	-	-	-	-	-
Unknown	-	-	-	-	-	1	-	1	-	-
Lost to follow-up	-	-	-	-	-	-	-	-	-	1
Protocol deviation	-	-	-	-	-	1	-	-	-	-

Notes
[2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: This trial has a crossover component and multiple sub-groups, so the number of participants in each group is not as expected.

Period 4 title

Period 4:Open Label, Safety Analysis Set

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Cohort A: Period 4 Open-label Olmesartan

Arm description

All remaining members of Cohort A (6-16 years old with a limit on the number of Black patients) were given 10 mg to 40 mg of olmesartan administered as oral suspension or tablets, depending on patient weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension, Tablet

Routes of administration

Oral use

Dosage and administration details

Patients received 10 mg olmesartan medoxomil suspension or 20 mg tablet(s) orally once daily for 46 weeks.

Cohort B: Period 4 Open-label Olmesartan

Arm description

All remaining members of Cohort B (6-16 years old comprised exclusively of Black patients) were given 10 mg to 40 mg of olmesartan administered as oral suspension or tablets, depending on patient weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension, Tablet

Routes of administration

Oral use

Dosage and administration details

Patients received 10 mg olmesartan medoxomil suspension or 20 mg tablet(s) orally once daily for 46 weeks.

Cohort C: OM in Periods 2, 3, and 4

Arm description

Patients in subgroup of cohort C (1-5 years old) were given olmesartan medoxomil 0.3 mg/kg in Period 2 (open-label period from day 0 to week 3) and patients in a subgroup of Cohort C were given that dose of OM during Period 3 (double-blind, placebo controlled period from week 3 to week 5). In Period 4 (open-label period from weeks 6-51), all patients in Cohort C (who received OM in Periods 2 and 3) received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two weeks, the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.

Arm type

Experimental

Investigational medicinal product name

Olmesartan Medoxomil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral suspension

Routes of administration

Oral use

Dosage and administration details

Number of subjects in period 4	Cohort A: Period 4 Open-label Olmesartan	Cohort B: Period 4 Open-label Olmesartan	Cohort C: OM in Periods 2, 3, and 4
Started	179	104	57
Completed	149	83	57
Not completed	30	21	0
Consent withdrawn by subject	5	2	-
Physician decision	-	2	-
Adverse event, non-fatal	1	2	-
Unknown	1	3	-
Increased blood pressure	1	1	-
Lost to follow-up	17	7	-
Non-compliance with Protocol	4	4	-
Protocol deviation	1	-	-

Baseline characteristics

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Reporting group title

Cohort A: High Dose OM in Periods 2 and 3

Reporting group description

Reporting group title

Cohort A: Low Dose OM in Periods 2 and 3

Reporting group description

Reporting group title

Cohort B: High Dose OM in Periods 2 and 3

Reporting group description

Reporting group title

Cohort B: Low Dose OM in Periods 2 and 3

Reporting group description

Reporting group title

Cohort C: OM in Periods 2, 3, and 4

Reporting group description

Reporting group values	Cohort A: High Dose OM in Periods 2 and 3	Cohort A: Low Dose OM in Periods 2 and 3	Cohort B: High Dose OM in Periods 2 and 3	Cohort B: Low Dose OM in Periods 2 and 3	Cohort C: OM in Periods 2, 3, and 4	Total
Number of subjects	95	95	56	56	60	362
Age categorical
Units: Subjects
In utero						0
Preterm newborn infants (gestational age < 37 wks)						0
Newborns (0-27 days)						0
Infants and toddlers (28 days-23 months)						0
Children (2-11 years)						0
Adolescents (12-17 years)						0
Adults (18-64 years)						0
From 65-84 years						0
85 years and over						0
Age continuous
Units: years
arithmetic mean (standard deviation)	12.1 ( 2.97 )	12.3 ( 2.98 )	12.2 ( 2.83 )	12.8 ( 2.42 )	3.4 ( 1.45 )	-
Gender categorical
Units: Subjects
Female	33	35	35	20	26	149
Male	62	60	21	36	34	213

End points

Top of page

Reporting group title

All Patients

Reporting group description

Period 1 was a screening, wash-out period of approximately two weeks. All participants were included in the screening, wash-out period and during this period no intervention was administered.

Reporting group title

Cohort A: High Dose OM in Periods 2 and 3

Reporting group description

Reporting group title

Cohort A: Low Dose OM in Periods 2 and 3

Reporting group description

Reporting group title

Cohort B: High Dose OM in Periods 2 and 3

Reporting group description

Reporting group title

Cohort B: Low Dose OM in Periods 2 and 3

Reporting group description

Reporting group title

Cohort C: OM in Periods 2, 3, and 4

Reporting group description

Reporting group title

Cohort A: High Dose OM in Periods 2 and 3

Reporting group description

Reporting group title

Cohort A: Low Dose OM in Periods 2 and 3

Reporting group description

Reporting group title

Cohort B: High Dose OM in Periods 2 and 3

Reporting group description

Reporting group title

Cohort B: Low Dose OM in Periods 2 and 3

Reporting group description

Reporting group title

Cohort C: OM in Periods 2, 3, and 4

Reporting group description

Reporting group title

Cohort A: Placebo in Period 3 (From High Dose in Period 2)

Reporting group description

Reporting group title

Cohort A: Placebo in Period 3 (From Low Dose in Period 2)

Reporting group description

Reporting group title

Cohort B: Placebo in Period 3 (From High Dose in Period 2)

Reporting group description

Reporting group title

Cohort B: Placebo in Period 3 (From Low Dose in Period 2)

Reporting group description

Reporting group title

Cohort C: Placebo in Period 3 (From OM in Period 2)

Reporting group description

Patients in subgroup of Cohort C (1-5 years old), given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5).

Reporting group title

Cohort A: Period 4 Open-label Olmesartan

Reporting group description

Reporting group title

Cohort B: Period 4 Open-label Olmesartan

Reporting group description

Reporting group title

Cohort C: OM in Periods 2, 3, and 4

Reporting group description

Patients in subgroup of cohort C (1-5 years old) were given olmesartan medoxomil 0.3 mg/kg in Period 2 (open-label period from day 0 to week 3) and patients in a subgroup of Cohort C were given that dose of OM during Period 3 (double-blind, placebo controlled period from week 3 to week 5). In Period 4 (open-label period from weeks 6-51), all patients in Cohort C (who received OM in Periods 2 and 3) received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two weeks, the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.

Subject analysis set title

Cohort A: High Dose OM

Subject analysis set type

Full analysis

Subject analysis set description

Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).

Subject analysis set title

Cohort A: Low Dose OM

Subject analysis set type

Full analysis

Subject analysis set description

Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).

Subject analysis set title

Cohort B: High Dose OM

Subject analysis set type

Full analysis

Subject analysis set description

Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).

Subject analysis set title

Cohort B: Low Dose OM

Subject analysis set type

Full analysis

Subject analysis set description

Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).

Subject analysis set title

Cohort C: OM (Olmesartan Medoxomil)

Subject analysis set type

Full analysis

Subject analysis set description

Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.

Subject analysis set title

Cohort A

Subject analysis set type

Full analysis

Subject analysis set description

Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.

Subject analysis set title

Cohort B

Subject analysis set type

Full analysis

Subject analysis set description

Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.

Subject analysis set title

Cohorts A + B

Subject analysis set type

Full analysis

Subject analysis set description

Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.

Subject analysis set title

Cohorts A + B: Low Dose OM

Subject analysis set type

Full analysis

Subject analysis set description

Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.

Subject analysis set title

Cohorts A + B: High Dose OM

Subject analysis set type

Full analysis

Subject analysis set description

Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.

Subject analysis set title

Cohort A: OM Period 3

Subject analysis set type

Full analysis

Subject analysis set description

Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.

Subject analysis set title

Cohort A: Placebo Period 3

Subject analysis set type

Full analysis

Subject analysis set description

Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.

Subject analysis set title

Cohort B: OM Period 3

Subject analysis set type

Full analysis

Subject analysis set description

Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.

Subject analysis set title

Cohort B: Placebo Period 3

Subject analysis set type

Full analysis

Subject analysis set description

Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.

Subject analysis set title

Cohorts A + B: OM Period 3

Subject analysis set type

Full analysis

Subject analysis set description

Cohort A + B participants were 6-16 years old. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.

Subject analysis set title

Cohorts A + B: Placebo Period 3

Subject analysis set type

Full analysis

Subject analysis set description

Cohorts A + B participants were 6-16 years old. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.

Subject analysis set title

Cohort C: OM Period 3

Subject analysis set type

Full analysis

Subject analysis set description

Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group continued on its Period 2 olmesartan dose of 0.3 mg/kg.

Subject analysis set title

Cohort C: Placebo Period 3

Subject analysis set type

Full analysis

Subject analysis set description

Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group was switched from its Period 2 olmesartan dose of 0.3 mg/kg to placebo.

Subject analysis set title

Cohorts A + B: Period 4 Open-label OM

Subject analysis set type

Full analysis

Subject analysis set description

Subjects of Cohorts A + B (6-16 years old) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the openlabel Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.

Primary: Least Squares Mean Change from Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 weeks)

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End point title

Least Squares Mean Change from Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 weeks)

End point description

The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline. The number of participants includes all randomized to Cohort A, Cohort B and a combination of the two cohorts. The Last Observation Carried Forward method was used in the linear regression analysis for the change in the seated systolic blood pressure from baseline to the end of three weeks.

End point type

Primary

End point timeframe

Day 0 to 3 weeks

End point values	Cohort A	Cohort B	Cohorts A + B
Number of subjects analysed	190	112	302
Units: millimeter of mercury (mm Hg)
least squares mean (standard error)
Non-weight adjusted dosage	-0.69 ( 0.202 )	-0.85 ( 0.282 )	-0.75 ( 0.165 )
Weight adjusted dosage	-8.97 ( 2.054 )	-7.17 ( 3.19 )	-8.36 ( 1.75 )

Cohort A Non-weight adjusted dosage

Comparison groups

Cohort A v Cohort B v Cohorts A + B

Number of subjects included in analysis

604

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0008

Method

Regression, Linear

Confidence interval

Cohort A Weight adjusted dosage

Comparison groups

Cohort A v Cohort B v Cohorts A + B

Number of subjects included in analysis

604

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001

Method

Regression, Linear

Confidence interval

Cohort B Non-weight adjusted dosage

Comparison groups

Cohort B v Cohort A v Cohorts A + B

Number of subjects included in analysis

604

Analysis specification

Pre-specified

Analysis type

other

P-value

= 0.0032

Method

Regression, Linear

Confidence interval

Cohort B Weight adjusted dosage

Comparison groups

Cohort B v Cohort A v Cohorts A + B

Number of subjects included in analysis

604

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.001

Method

Regression, Linear

Confidence interval

Cohorts A + B Weight adjusted dosage

Comparison groups

Cohorts A + B v Cohort A v Cohort B

Number of subjects included in analysis

604

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001

Method

Regression, Linear

Confidence interval

Cohorts A + B Non-weight adjusted dosage

Comparison groups

Cohorts A + B v Cohort A v Cohort B

Number of subjects included in analysis

604

Analysis specification

Pre-specified

Analysis type

other

P-value

< 0.0001

Method

Regression, Linear

Confidence interval

Primary: Mean Change from Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 weeks)

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End point title

Mean Change from Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 weeks)

End point description

Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined. The Intent-to-Treat (ITT) population for Period II of the study was defined as subjects who took at least one dose of study medication and had study baseline and at least one seated systolic, or diastolic blood pressure measurement after taking study medication. The Last Observation carried forward was used.

End point type

Primary

End point timeframe

Day 0 (baseline) to 3 weeks

End point values	Cohort A: High Dose OM	Cohort A: Low Dose OM	Cohort B: High Dose OM	Cohort B: Low Dose OM	Cohorts A + B: Low Dose OM	Cohorts A + B: High Dose OM
Number of subjects analysed	94	94	56	56	150	150
Units: mm Hg
arithmetic mean (standard deviation)
Change in Systolic Blood Pressure	-12.58 ( 10.157 )	-7.76 ( 9.18 )	-10.68 ( 9.259 )	-4.73 ( 11.483 )	-6.63 ( 10.17 )	-11.87 ( 9.843 )
Change in Diastolic Blood Pressure	-9.5 ( 9.757 )	-5.52 ( 8.058 )	-7.58 ( 8.172 )	-3.49 ( 8.844 )	-4.76 ( 8.389 )	-8.78 ( 9.216 )

Statistical Analysis_1

Statistical analysis description

A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.

Comparison groups

Cohort A: High Dose OM v Cohort A: Low Dose OM

Number of subjects included in analysis

188

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.0008

Method

Regression, Linear

Confidence interval

Statistical Analysis_2

Statistical analysis description

A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.

Comparison groups

Cohort A: Low Dose OM v Cohort A: High Dose OM

Number of subjects included in analysis

188

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.0026

Method

Regression, Linear

Confidence interval

Statistical Analysis_3

Statistical analysis description

A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.

Comparison groups

Cohort B: Low Dose OM v Cohort B: High Dose OM

Number of subjects included in analysis

112

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.0032

Method

Regression, Linear

Confidence interval

Statistical Analysis_5

Statistical analysis description

A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.

Comparison groups

Cohorts A + B: Low Dose OM v Cohorts A + B: High Dose OM

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

< 0.0001

Method

Regression, Linear

Confidence interval

Statistical Analysis_4

Statistical analysis description

A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.

Comparison groups

Cohort B: Low Dose OM v Cohort B: High Dose OM

Number of subjects included in analysis

112

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.0125

Method

Regression, Linear

Confidence interval

Statistical Analysis_6

Statistical analysis description

A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.

Comparison groups

Cohorts A + B: Low Dose OM v Cohorts A + B: High Dose OM

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

< 0.0001

Method

Regression, Linear

Confidence interval

Statistical Analysis_7

Statistical analysis description

A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.

Comparison groups

Cohort A: Low Dose OM v Cohort A: High Dose OM

Number of subjects included in analysis

188

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

< 0.0001

Method

Regression, Linear

Confidence interval

Statistical Analysis_8

Statistical analysis description

A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.

Comparison groups

Cohort A: Low Dose OM v Cohort A: High Dose OM

Number of subjects included in analysis

188

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

< 0.0001

Method

Regression, Linear

Confidence interval

Statistical Analysis_9

Statistical analysis description

A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.

Comparison groups

Cohort B: Low Dose OM v Cohort B: High Dose OM

Number of subjects included in analysis

112

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.0265

Method

Regression, Linear

Confidence interval

Statistical Analysis_10

Statistical analysis description

A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.

Comparison groups

Cohort B: Low Dose OM v Cohort B: High Dose OM

Number of subjects included in analysis

112

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.0084

Method

Regression, Linear

Confidence interval

Statistical Analysis_11

Statistical analysis description

A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.

Comparison groups

Cohorts A + B: Low Dose OM v Cohorts A + B: High Dose OM

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

< 0.0001

Method

Regression, Linear

Confidence interval

Statistical Analysis_12

Statistical analysis description

A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.

Comparison groups

Cohorts A + B: Low Dose OM v Cohorts A + B: High Dose OM

Number of subjects included in analysis

300

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

< 0.0001

Method

Regression, Linear

Parameter type

Slope

Confidence interval

Secondary: Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

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End point title

Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

End point description

Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B, Cohorts A+B combined and Cohort C. Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement. Intent-to-treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.

End point type

Secondary

End point timeframe

Week 3 (period 3 baseline) to week 5 (end of Period 3)

End point values	Cohort A: OM Period 3	Cohort A: Placebo Period 3	Cohort B: OM Period 3	Cohort B: Placebo Period 3	Cohorts A + B: OM Period 3	Cohorts A + B: Placebo Period 3	Cohort C: OM Period 3	Cohort C: Placebo Period 3
Number of subjects analysed	93	89	53	54	146	143	29	29
Units: mm Hg
arithmetic mean (standard deviation)
Change in Systolic Blood Pressure	0.43 ( 9.46 )	4.93 ( 9.62 )	1.37 ( 9.5 )	3.79 ( 10 )	0.77 ( 9.451 )	4.5 ( 9.745 )	1.36 ( 8.994 )	4.95 ( 8.568 )
Change in Diastolic Blood Pressure	0.24 ( 8.12 )	4.43 ( 10.15 )	1.94 ( 7.1 )	3.25 ( 8.74 )	0.85 ( 7.79 )	3.99 ( 9.627 )	0.31 ( 8.556 )	3.77 ( 7.203 )

Statistical Analysis_1

Statistical analysis description

Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested. The number of subjects included in analysis was 93 for Cohort A: OM Period 3 and 89 for Cohort A: Placebo Period 3.

Comparison groups

Cohort A: OM Period 3 v Cohort A: Placebo Period 3

Number of subjects included in analysis

182

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0093

Method

ANCOVA

Parameter type

LS Mean Difference

Point estimate

-3.58

Confidence interval

level

95%

sides

2-sided

lower limit

-6.27

upper limit

-0.89

Statistical Analysis_2

Statistical analysis description

Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested. The number of subjects included in analysis was 93 for Cohort A: OM Period 3 and 89 for Cohort A: Placebo Period 3.

Comparison groups

Cohort A: OM Period 3 v Cohort A: Placebo Period 3

Number of subjects included in analysis

182

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0052

Method

ANCOVA

Parameter type

LS Mean difference

Point estimate

-3.49

Confidence interval

level

95%

sides

2-sided

lower limit

-5.92

upper limit

-1.05

Statistical Analysis_3

Statistical analysis description

Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested. The number of subjects included in analysis was 53 for Cohort B: OM Period 3 and 54 for Cohort B: Placebo Period 3.

Comparison groups

Cohort B: OM Period 3 v Cohort B: Placebo Period 3

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.133

Method

ANCOVA

Parameter type

LS Mean difference

Point estimate

-2.57

Confidence interval

level

95%

sides

2-sided

lower limit

-5.93

upper limit

0.79

Statistical Analysis_4

Statistical analysis description

Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested. The number of subjects included in analysis was 53 for Cohort B: OM Period 3 and 54 for Cohort B: Placebo Period 3.

Comparison groups

Cohort B: OM Period 3 v Cohort B: Placebo Period 3

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3442

Method

ANCOVA

Parameter type

LS Mean difference

Point estimate

-1.38

Confidence interval

level

95%

sides

2-sided

lower limit

-4.27

upper limit

1.5

Statistical Analysis_5

Statistical analysis description

For seated systolic blood pressure the null hypothesis of no treatment difference was tested. The number of subjects included in analysis was 146 for Cohorts A + B: OM Period 3 and 143 for Cohorts A + B: Placebo Period 3.

Comparison groups

Cohorts A + B: OM Period 3 v Cohorts A + B: Placebo Period 3

Number of subjects included in analysis

289

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0029

Method

ANCOVA

Parameter type

LS Mean difference

Point estimate

-3.16

Confidence interval

level

95%

sides

2-sided

lower limit

-5.24

upper limit

-1.09

Statistical Analysis_6

Statistical analysis description

For seated diastolic blood pressure the null hypothesis of no treatment difference was tested. The number of subjects included in analysis was 146 for Cohorts A + B: OM Period 3 and 143 for Cohorts A + B: Placebo Period 3.

Comparison groups

Cohorts A + B: OM Period 3 v Cohorts A + B: Placebo Period 3

Number of subjects included in analysis

289

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0032

Method

ANCOVA

Parameter type

LS Mean difference

Point estimate

-2.8

Confidence interval

level

95%

sides

2-sided

lower limit

-4.65

upper limit

-0.95

Statistical Analysis_7

Statistical analysis description

For seated systolic blood pressure the null hypothesis of no treatment difference was tested. The number of subjects included in analysis was 29 for Cohort C: OM Period 3 and 29 for Cohort C: Placebo Period 3.

Comparison groups

Cohort C: OM Period 3 v Cohort C: Placebo Period 3

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2113

Method

ANCOVA

Parameter type

LS Mean difference

Point estimate

-2.82

Confidence interval

level

95%

sides

2-sided

lower limit

-7.29

upper limit

1.65

Statistical Analysis_8

Statistical analysis description

For seated diastolic blood pressure the null hypothesis of no treatment difference was tested. The number of subjects included in analysis was 29 for Cohort C: OM Period 3 and 29 for Cohort C: Placebo Period 3.

Comparison groups

Cohort C: OM Period 3 v Cohort C: Placebo Period 3

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1496

Method

ANCOVA

Parameter type

LS Mean difference

Point estimate

-2.92

Confidence interval

level

95%

sides

2-sided

lower limit

-6.92

upper limit

1.09

Secondary: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (end of study)

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End point title

Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (end of study)

End point description

Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined. Intent to treat population includes participants with at least one visit in Period 4.

End point type

Secondary

End point timeframe

Day 0 to week 51 (end of study)

End point values	Cohorts A + B: Period 4 Open-label OM
Number of subjects analysed	281
Units: mm Hg
arithmetic mean (standard deviation)
Change in Systolic Blood Pressure	-9.7 ( 11.01 )
Change in Diastolic Blood Pressure	-6.6 ( 9.41 )

No statistical analyses for this end point

Secondary: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study) for Cohort C

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End point title

Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study) for Cohort C

End point description

Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort C. Subjects included who received medication in Period 4.

End point type

Secondary

End point timeframe

Day 0 to week 51 week (end of study)

End point values	Cohort C: OM (Olmesartan Medoxomil)
Number of subjects analysed	57
Units: mm Hg
arithmetic mean (standard deviation)
Change in Systolic Blood Pressure	-15.7 ( 9.83 )
Change in Diastolic Blood Pressure	-13.3 ( 11.18 )

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks).

Adverse event reporting additional description

AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator’s opinion of the causal relationship to the treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

8.1

Reporting group title

Cohort A: Period 2 Low Dose OM

Reporting group description

For Cohort A (patients 6-16 years old) olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight

Reporting group title

Cohort A: Period 2 High Dose OM

Reporting group description

For Cohort A (patients 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight

Reporting group title

Cohort A: Period 3 OM High Dose Continued

Reporting group description

The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.

Reporting group title

Cohort A: Period 3 Placebo From High Dose

Reporting group description

Placebo was given instead of the previous high dose of olmesartan.

Reporting group title

Cohort A: Period 3 OM Low Dose Continued

Reporting group description

The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.

Reporting group title

Cohort A: Period 3 Placebo From Low Dose

Reporting group description

Placebo was given instead of the previous low dose of olmesartan.

Reporting group title

Cohort A: Period 4 Open-label OM

Reporting group description

10 mg to 40 mg of olmesartan was administered as oral suspension or tablets depending on patient weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.

Reporting group title

Cohort B: Period 2 High Dose OM

Reporting group description

For Cohort B (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.

Reporting group title

Cohort B: Period 2 Low Dose OM

Reporting group description

For Cohort B (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.

Reporting group title

Cohort B: Period 3 Placebo From High Dose

Reporting group description

Placebo was given instead of the previous high dose of olmesartan.

Reporting group title

Cohort B: Period 3 OM Low Dose Continued

Reporting group description

The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.

Reporting group title

Cohort B: Period 3 OM High Dose Continued

Reporting group description

The 20 mg or 40 mg dose of olmesartan medoximil suspension (OM) from the previous period was continued.

Reporting group title

Cohort C: Period 3 Placebo From OM in Period 2

Reporting group description

The 0.3 mg/kg dose of olmesartan medoxomil suspension (OM) was discontinued for these participants. They were switched to placebo.

Reporting group title

Cohort B: Period 3 Placebo From Low Dose

Reporting group description

Placebo was given instead of the previous low dose of olmesartan.

Reporting group title

Cohort B: Period 4 Open-label OM

Reporting group description

Reporting group title

Cohort C: Period 2 Open-label OM

Reporting group description

The dose of olmesarten medoxomil suspension (OM) was 0.3 mg/kg for all patients who were 1 to 5 years of age.

Reporting group title

Cohort C: Period 3 OM Dose Continued

Reporting group description

The 0.3 mg/kg dose of OM was continued for these patients.

Reporting group title

Cohort C: Period 4 Open-label OM

Reporting group description

Patients received an olmesartan medoxomil suspension (OM) starting dose of 0.3 mg/kg. If hypertension was not controlled after two weeks the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.

Cohort A: Period 2 Low Dose OM

Cohort A: Period 2 High Dose OM

Cohort A: Period 3 OM High Dose Continued

Cohort A: Period 3 Placebo From High Dose

Cohort A: Period 3 OM Low Dose Continued

Cohort A: Period 3 Placebo From Low Dose

Cohort A: Period 4 Open-label OM

Cohort B: Period 2 High Dose OM

Cohort B: Period 2 Low Dose OM

Cohort B: Period 3 Placebo From High Dose

Cohort B: Period 3 OM Low Dose Continued

Cohort B: Period 3 OM High Dose Continued

Cohort C: Period 3 Placebo From OM in Period 2

Cohort B: Period 3 Placebo From Low Dose

Cohort B: Period 4 Open-label OM

Cohort C: Period 2 Open-label OM

Cohort C: Period 3 OM Dose Continued

Cohort C: Period 4 Open-label OM

Total subjects affected by serious adverse events

subjects affected / exposed

1 / 95 (1.05%)

2 / 95 (2.11%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

20 / 179 (11.17%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

1 / 26 (3.85%)

0 / 29 (0.00%)

0 / 26 (0.00%)

7 / 104 (6.73%)

0 / 59 (0.00%)

0 / 29 (0.00%)

6 / 57 (10.53%)

number of deaths (all causes)

number of deaths resulting from adverse events

Investigations

Laparoscopy

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

1 / 179 (0.56%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Congenital, familial and genetic disorders

Coarctation of the aorta

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

1 / 179 (0.56%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Anasarca

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

1 / 179 (0.56%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Eye hemorrhage

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

0 / 179 (0.00%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

1 / 57 (1.75%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Ophthalmoplegia

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

1 / 179 (0.56%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

2 / 104 (1.92%)

0 / 59 (0.00%)

0 / 29 (0.00%)

1 / 57 (1.75%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Reproductive system and breast disorders

Ovarian cyst

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

0 / 179 (0.00%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

1 / 57 (1.75%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Peritonitis

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

0 / 179 (0.00%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

1 / 104 (0.96%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vomiting

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

2 / 179 (1.12%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Asthma

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

0 / 179 (0.00%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

1 / 104 (0.96%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Epistaxis

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

0 / 179 (0.00%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

1 / 104 (0.96%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Depression

subjects affected / exposed

0 / 95 (0.00%)

1 / 95 (1.05%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

1 / 179 (0.56%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mental disorder

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

1 / 179 (0.56%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Suicide attempt

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

1 / 179 (0.56%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Ureteric stenosis

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

1 / 179 (0.56%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nephrotic syndrome

alternative assessment type: Non-systematic

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

0 / 179 (0.00%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

1 / 104 (0.96%)

0 / 59 (0.00%)

0 / 29 (0.00%)

1 / 57 (1.75%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Arthralgia

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

2 / 179 (1.12%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Systemic lupus erythematosus

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

1 / 179 (0.56%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

1 / 104 (0.96%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Abcess limb

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

0 / 179 (0.00%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

1 / 104 (0.96%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bronchitis

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

1 / 179 (0.56%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Broncopneumonia

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

3 / 179 (1.68%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

2 / 57 (3.51%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

0 / 179 (0.00%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

1 / 57 (1.75%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Pyelonephritis

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

0 / 179 (0.00%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

1 / 26 (3.85%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Sinusitis

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

2 / 179 (1.12%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Upper respiratory infection

subjects affected / exposed

0 / 95 (0.00%)

1 / 95 (1.05%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

0 / 179 (0.00%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Diabetic ketoacidosis

subjects affected / exposed

1 / 95 (1.05%)

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

0 / 179 (0.00%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypoproteinemia

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

1 / 179 (0.56%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolic disorder

subjects affected / exposed

0 / 95 (0.00%)

0 / 48 (0.00%)

0 / 45 (0.00%)

0 / 44 (0.00%)

1 / 179 (0.56%)

0 / 56 (0.00%)

0 / 28 (0.00%)

0 / 27 (0.00%)

0 / 26 (0.00%)

0 / 29 (0.00%)

0 / 26 (0.00%)

0 / 104 (0.00%)

0 / 59 (0.00%)

0 / 29 (0.00%)

0 / 57 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 4%

Non-serious adverse events	Cohort A: Period 2 Low Dose OM	Cohort A: Period 2 High Dose OM	Cohort A: Period 3 OM High Dose Continued	Cohort A: Period 3 Placebo From High Dose	Cohort A: Period 3 OM Low Dose Continued	Cohort A: Period 3 Placebo From Low Dose	Cohort A: Period 4 Open-label OM	Cohort B: Period 2 High Dose OM	Cohort B: Period 2 Low Dose OM	Cohort B: Period 3 Placebo From High Dose	Cohort B: Period 3 OM Low Dose Continued	Cohort B: Period 3 OM High Dose Continued	Cohort C: Period 3 Placebo From OM in Period 2	Cohort B: Period 3 Placebo From Low Dose	Cohort B: Period 4 Open-label OM	Cohort C: Period 2 Open-label OM	Cohort C: Period 3 OM Dose Continued	Cohort C: Period 4 Open-label OM
Total subjects affected by non serious adverse events
subjects affected / exposed	46 / 95 (48.42%)	47 / 95 (49.47%)	15 / 48 (31.25%)	6 / 45 (13.33%)	9 / 45 (20.00%)	6 / 44 (13.64%)	128 / 179 (71.51%)	9 / 56 (16.07%)	12 / 56 (21.43%)	1 / 28 (3.57%)	2 / 27 (7.41%)	4 / 26 (15.38%)	8 / 29 (27.59%)	1 / 26 (3.85%)	56 / 104 (53.85%)	12 / 59 (20.34%)	4 / 29 (13.79%)	46 / 57 (80.70%)
Investigations
Blood urea increased
subjects affected / exposed	0 / 95 (0.00%)	0 / 95 (0.00%)	0 / 48 (0.00%)	2 / 45 (4.44%)	0 / 45 (0.00%)	0 / 44 (0.00%)	0 / 179 (0.00%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	0 / 104 (0.00%)	0 / 59 (0.00%)	0 / 29 (0.00%)	0 / 57 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Nervous system disorders
Dizziness
subjects affected / exposed	2 / 95 (2.11%)	9 / 95 (9.47%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	10 / 179 (5.59%)	1 / 56 (1.79%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	1 / 29 (3.45%)	0 / 26 (0.00%)	2 / 104 (1.92%)	0 / 59 (0.00%)	0 / 29 (0.00%)	0 / 57 (0.00%)
occurrences all number	2	11	0	0	0	0	13	1	0	0	0	0	1	0	4	0	0	0
Headache
subjects affected / exposed	7 / 95 (7.37%)	14 / 95 (14.74%)	4 / 48 (8.33%)	1 / 45 (2.22%)	3 / 45 (6.67%)	2 / 44 (4.55%)	30 / 179 (16.76%)	5 / 56 (8.93%)	3 / 56 (5.36%)	0 / 28 (0.00%)	1 / 27 (3.70%)	2 / 26 (7.69%)	0 / 29 (0.00%)	1 / 26 (3.85%)	18 / 104 (17.31%)	1 / 59 (1.69%)	0 / 29 (0.00%)	1 / 57 (1.75%)
occurrences all number	11	24	5	1	3	2	42	5	3	0	1	2	0	1	38	1	0	1
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	4 / 95 (4.21%)	4 / 95 (4.21%)	3 / 48 (6.25%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	16 / 179 (8.94%)	1 / 56 (1.79%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	2 / 104 (1.92%)	3 / 59 (5.08%)	0 / 29 (0.00%)	7 / 57 (12.28%)
occurrences all number	4	4	3	0	0	0	21	1	0	0	0	0	0	0	2	3	0	8
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	5 / 95 (5.26%)	3 / 95 (3.16%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	10 / 179 (5.59%)	1 / 56 (1.79%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	9 / 104 (8.65%)	0 / 59 (0.00%)	0 / 29 (0.00%)	0 / 57 (0.00%)
occurrences all number	7	3	0	0	0	0	10	1	0	0	0	0	0	0	15	0	0	0
Vomiting
subjects affected / exposed	3 / 95 (3.16%)	1 / 95 (1.05%)	3 / 48 (6.25%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	11 / 179 (6.15%)	0 / 56 (0.00%)	1 / 56 (1.79%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	7 / 104 (6.73%)	0 / 59 (0.00%)	0 / 29 (0.00%)	3 / 57 (5.26%)
occurrences all number	3	1	3	0	0	0	17	0	1	0	0	0	0	0	7	0	0	3
Diarrhea
subjects affected / exposed	2 / 95 (2.11%)	1 / 95 (1.05%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	2 / 179 (1.12%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	1 / 29 (3.45%)	0 / 26 (0.00%)	3 / 104 (2.88%)	1 / 59 (1.69%)	0 / 29 (0.00%)	4 / 57 (7.02%)
occurrences all number	2	1	0	0	0	0	2	0	0	0	0	0	1	0	3	1	0	5
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
subjects affected / exposed	6 / 95 (6.32%)	1 / 95 (1.05%)	2 / 48 (4.17%)	0 / 45 (0.00%)	1 / 45 (2.22%)	1 / 44 (2.27%)	12 / 179 (6.70%)	0 / 56 (0.00%)	0 / 56 (0.00%)	1 / 28 (3.57%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	3 / 104 (2.88%)	0 / 59 (0.00%)	0 / 29 (0.00%)	0 / 57 (0.00%)
occurrences all number	7	1	2	0	1	1	20	0	0	1	0	0	0	0	3	0	0	0
Cough
subjects affected / exposed	0 / 95 (0.00%)	0 / 95 (0.00%)	3 / 48 (6.25%)	0 / 45 (0.00%)	1 / 45 (2.22%)	1 / 44 (2.27%)	24 / 179 (13.41%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	1 / 26 (3.85%)	1 / 29 (3.45%)	0 / 26 (0.00%)	7 / 104 (6.73%)	3 / 59 (5.08%)	1 / 29 (3.45%)	5 / 57 (8.77%)
occurrences all number	0	0	3	0	1	1	28	0	0	0	0	1	1	0	8	3	1	6
Rhinorrhea
subjects affected / exposed	3 / 95 (3.16%)	2 / 95 (2.11%)	0 / 48 (0.00%)	0 / 45 (0.00%)	2 / 45 (4.44%)	0 / 44 (0.00%)	4 / 179 (2.23%)	0 / 56 (0.00%)	1 / 56 (1.79%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	2 / 104 (1.92%)	0 / 59 (0.00%)	0 / 29 (0.00%)	0 / 57 (0.00%)
occurrences all number	3	2	0	0	2	0	4	0	1	0	0	0	0	0	2	0	0	0
Epistaxis
subjects affected / exposed	2 / 95 (2.11%)	0 / 95 (0.00%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	3 / 179 (1.68%)	0 / 56 (0.00%)	1 / 56 (1.79%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	5 / 104 (4.81%)	0 / 59 (0.00%)	0 / 29 (0.00%)	2 / 57 (3.51%)
occurrences all number	2	0	0	0	0	0	9	0	1	0	0	0	0	0	5	0	0	3
Nasal congestion
subjects affected / exposed	0 / 95 (0.00%)	0 / 95 (0.00%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	9 / 179 (5.03%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	2 / 104 (1.92%)	0 / 59 (0.00%)	0 / 29 (0.00%)	0 / 57 (0.00%)
occurrences all number	0	0	0	0	0	0	10	0	0	0	0	0	0	0	2	0	0	0
Asthma
subjects affected / exposed	0 / 95 (0.00%)	0 / 95 (0.00%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	6 / 179 (3.35%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	2 / 104 (1.92%)	0 / 59 (0.00%)	0 / 29 (0.00%)	6 / 57 (10.53%)
occurrences all number	0	0	0	0	0	0	11	0	0	0	0	0	0	0	2	0	0	8
Rhinitis
subjects affected / exposed	0 / 95 (0.00%)	0 / 95 (0.00%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	0 / 179 (0.00%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	0 / 104 (0.00%)	0 / 59 (0.00%)	2 / 29 (6.90%)	4 / 57 (7.02%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	4
Renal and urinary disorders
Nephrotic syndrome
subjects affected / exposed	0 / 95 (0.00%)	0 / 95 (0.00%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	0 / 179 (0.00%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	2 / 104 (1.92%)	0 / 59 (0.00%)	0 / 29 (0.00%)	5 / 57 (8.77%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	7
Proteinurea
subjects affected / exposed	0 / 95 (0.00%)	0 / 95 (0.00%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	0 / 179 (0.00%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	0 / 104 (0.00%)	0 / 59 (0.00%)	0 / 29 (0.00%)	3 / 57 (5.26%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3
Infections and infestations
Nasopharyngitis
subjects affected / exposed	4 / 95 (4.21%)	1 / 95 (1.05%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	16 / 179 (8.94%)	1 / 56 (1.79%)	2 / 56 (3.57%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	2 / 29 (6.90%)	0 / 26 (0.00%)	4 / 104 (3.85%)	1 / 59 (1.69%)	0 / 29 (0.00%)	2 / 57 (3.51%)
occurrences all number	4	1	0	0	0	0	17	1	2	0	0	0	2	0	6	1	0	2
Upper respiratory tract infection
subjects affected / exposed	4 / 95 (4.21%)	7 / 95 (7.37%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	20 / 179 (11.17%)	0 / 56 (0.00%)	2 / 56 (3.57%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	3 / 104 (2.88%)	1 / 59 (1.69%)	1 / 29 (3.45%)	11 / 57 (19.30%)
occurrences all number	4	7	0	0	0	0	25	0	2	0	0	0	0	0	6	1	1	15
Influenza
subjects affected / exposed	0 / 95 (0.00%)	1 / 95 (1.05%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	2 / 44 (4.55%)	10 / 179 (5.59%)	0 / 56 (0.00%)	2 / 56 (3.57%)	0 / 28 (0.00%)	1 / 27 (3.70%)	1 / 26 (3.85%)	1 / 29 (3.45%)	0 / 26 (0.00%)	4 / 104 (3.85%)	1 / 59 (1.69%)	1 / 29 (3.45%)	3 / 57 (5.26%)
occurrences all number	0	1	0	0	0	2	12	0	2	0	1	1	1	0	4	1	1	3
Pharyngitis
subjects affected / exposed	2 / 95 (2.11%)	4 / 95 (4.21%)	0 / 48 (0.00%)	3 / 45 (6.67%)	2 / 45 (4.44%)	0 / 44 (0.00%)	7 / 179 (3.91%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	0 / 104 (0.00%)	0 / 59 (0.00%)	0 / 29 (0.00%)	2 / 57 (3.51%)
occurrences all number	2	4	0	3	2	0	7	0	0	0	0	0	0	0	0	0	0	2
Otitis media acute
subjects affected / exposed	0 / 95 (0.00%)	0 / 95 (0.00%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	0 / 179 (0.00%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	0 / 104 (0.00%)	1 / 59 (1.69%)	0 / 29 (0.00%)	3 / 57 (5.26%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	4
Tonsilitis
subjects affected / exposed	0 / 95 (0.00%)	0 / 95 (0.00%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	0 / 179 (0.00%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	0 / 104 (0.00%)	0 / 59 (0.00%)	0 / 29 (0.00%)	5 / 57 (8.77%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	8
Urinary tract infection
subjects affected / exposed	0 / 95 (0.00%)	0 / 95 (0.00%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	4 / 179 (2.23%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	0 / 104 (0.00%)	0 / 59 (0.00%)	0 / 29 (0.00%)	4 / 57 (7.02%)
occurrences all number	0	0	0	0	0	0	5	0	0	0	0	0	0	0	0	0	0	4
Viral infection
subjects affected / exposed	2 / 95 (2.11%)	0 / 95 (0.00%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	0 / 179 (0.00%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	0 / 29 (0.00%)	0 / 26 (0.00%)	0 / 104 (0.00%)	0 / 59 (0.00%)	0 / 29 (0.00%)	3 / 57 (5.26%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3
Metabolism and nutrition disorders
Pseudohyperkalemia
subjects affected / exposed	0 / 95 (0.00%)	0 / 95 (0.00%)	0 / 48 (0.00%)	0 / 45 (0.00%)	0 / 45 (0.00%)	0 / 44 (0.00%)	0 / 179 (0.00%)	0 / 56 (0.00%)	0 / 56 (0.00%)	0 / 28 (0.00%)	0 / 27 (0.00%)	0 / 26 (0.00%)	2 / 29 (6.90%)	0 / 26 (0.00%)	0 / 104 (0.00%)	0 / 59 (0.00%)	0 / 29 (0.00%)	0 / 57 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0

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Were there any global substantial amendments to the protocol? Yes

02 May 2005

The amendment was included to increase the number of subjects in Cohort C from 50 to 60, added glomerular kidney disease to the definition of subjects with hypertension as greater than or equal to (>=)90th percentile in the inclusion criteria, added greater than (>) 2 standard deviation (SD) to the exclusion criteria for seated systolic blood pressure (SeSBP) / seated diastolic blood pressure (SeDBP) in subjects with malignant hypertension, changed the primary efficacy analysis to include the change from baseline in SeDBP, and amended statistical analyses to include examination of Cohorts A, B, and A + B combined.

06 Mar 2006

The amendment was included to clarified conditions for interpretation of screening potassium levels, added angiotensin converting enzyme (ACE) inhibitors as an excluded antihypertensive medication during Period IV, added SeDBP to the definition of malignant hypertension, and identified the central clinical laboratory.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Least Squares Mean Change from Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 weeks)

Primary: Least Squares Mean Change from Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 weeks)

Primary: Mean Change from Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 weeks)

Primary: Mean Change from Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 weeks)

Secondary: Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

Secondary: Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

Secondary: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (end of study)

Secondary: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (end of study)

Secondary: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study) for Cohort C

Secondary: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study) for Cohort C

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Least Squares Mean Change from Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 weeks)

Primary: Least Squares Mean Change from Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 weeks)

Primary: Mean Change from Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 weeks)

Primary: Mean Change from Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 weeks)

Secondary: Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

Secondary: Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

Secondary: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (end of study)

Secondary: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (end of study)

Secondary: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study) for Cohort C

Secondary: Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study) for Cohort C

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension