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Clinical Trial Results:
A Dose-ranging, Safety and Pharmacokinetics Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to Less Than 6 Years of Age: A 4-week, Multicenter, Randomized, Double-Blind Study with a 1-year Open-label, Follow-up Period

Summary
EudraCT number	2004-004264-75
Trial protocol	BE GB DE DK IT
Global end of trial date	07 Aug 2008

Results information
Results version number	v1(current)
This version publication date	09 Mar 2016
First version publication date	09 Mar 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

D2451C0002

ISRCTN number

US NCT number

NCT00244621

WHO universal trial number (UTN)

Sponsor organisation name

AstraZeneca

Sponsor organisation address

Pepparedsleden 1, Molndal, Sweden, 431 83

Public contact

Robin Mukherjee, R&D/GMD/Biometrics & Information Sciences, robin.mukherjee@astrazeneca.com

Scientific contact

Robin Mukherjee, R&D/GMD/Biometrics & Information Sciences, robin.mukherjee@astrazeneca.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

25 Mar 2009

Is this the analysis of the primary completion data?

Yes

Primary completion date

07 Aug 2008

Global end of trial reached?

Yes

Global end of trial date

07 Aug 2008

Was the trial ended prematurely?

Main objective of the trial

The primary objective of this study was to characterize the dose response relationship of candesartan cilexetil (administered once daily) in hypertensive pediatric subjects (1 to <6 years of age) by evaluation of the slope of the linear regression for the change in trough systolic blood pressure (SBP) from baseline (Day 0) to the end of the 4-week, double-blind treatment period (Day 28) as a function of dose.

Protection of trial subjects

The study ICI and the AstraZeneca Study Physician reviewed and discussed each SAE. In addition, an independant pediatric hypertension expert not otherwise participating in the study reviewed all SAEs, Aes and Aes leading to discontinuation of study drug.

Background therapy

Evidence for comparator

Actual start date of recruitment

04 Nov 2004

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy, Safety

Long term follow-up duration

12 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Åland Islands: 93

Worldwide total number of subjects

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)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study population included male and female participants 1 to <6 years of age with mild to moderate hypertension. The participants were recruited during the time period from 04 November 2004 to 07 August 2008 at pediatric clinics in the USA, Puerto Rico and Europe.

Screening details

One to 2 weeks following a screening evaluation, participants underwent a 1-week, single-blind, placebo run-in period to reduce the variability in the baseline blood pressure measurements and to stabilize any concurrent antihypertensive medications.

Period 1 title

Double-blind treatment period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Monitor, Subject, Carer, Data analyst, Assessor

Are arms mutually exclusive

Yes

Atacand .05 mg

Arm description

candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose

Arm type

Experimental

Investigational medicinal product name

Candesartan cilexetil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral liquid

Routes of administration

Oral use

Dosage and administration details

.05mg

Atacand .20 mg

Arm description

candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose

Arm type

Experimental

Investigational medicinal product name

Candesartan cilexetil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral liquid

Routes of administration

Oral use

Dosage and administration details

.20mg

Atacand .40 mg

Arm description

candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose

Arm type

Experimental

Investigational medicinal product name

Candesartan cilexetil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral liquid

Routes of administration

Oral use

Dosage and administration details

.40mg

Number of subjects in period 1	Atacand .05 mg	Atacand .20 mg	Atacand .40 mg
Started	29	32	32
Completed	27	29	30
Not completed	2	3	2
Consent withdrawn by subject	-	1	-
Multiple Reasons	2	1	1
Lost to follow-up	-	-	1
Lack of efficacy	-	1	-

Period 2 title

Open-label treatment period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Data analyst, Assessor

Open-Label

Arm description

Arm type

Follow-up

Investigational medicinal product name

Candesartan cilexetil

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral liquid

Routes of administration

Oral use

Dosage and administration details

0.05mg

Number of subjects in period 2 ^[1]	Open-Label
Started	85
Completed	81
Not completed	4
Adverse event, serious fatal	1
Consent withdrawn by subject	1
Lost to follow-up	1
Moved abroad	1

Notes
[1] - 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: One participant discontinued study due to Adverse Event after completing the double-blind period

Baseline characteristics

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Reporting group title

Atacand .05 mg

Reporting group description

candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose

Reporting group title

Atacand .20 mg

Reporting group description

candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose

Reporting group title

Atacand .40 mg

Reporting group description

candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose

Reporting group values	Atacand .05 mg	Atacand .20 mg	Atacand .40 mg	Total
Number of subjects	29	32	32	93
Age categorical
Units: Subjects
Children (1-5)	29	32	32	93
Age continuous
Units: years
arithmetic mean (full range (min-max))	3 (1 to 5)	3.3 (1 to 5)	3 (1 to 5)	-
Gender, Male/Female
Units: Participants
Female	11	10	12	33
Male	18	22	20	60
Age, Customized
Units: Subjects
1 to <2 years	6	5	5	16
2 to <6 years	23	27	27	77

End points

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Reporting group title

Atacand .05 mg

Reporting group description

candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose

Reporting group title

Atacand .20 mg

Reporting group description

candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose

Reporting group title

Atacand .40 mg

Reporting group description

candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose

Reporting group title

Open-Label

Reporting group description

Primary: Mean change from baseline to week 4 in systolic blood pressure (SBP)

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End point title

Mean change from baseline to week 4 in systolic blood pressure (SBP)

End point description

End point type

Primary

End point timeframe

From randomisation to end of double-blind treatment (4 weeks)

End point values	Atacand .05 mg	Atacand .20 mg	Atacand .40 mg
Number of subjects analysed	29	32	32
Units: mm Hg
arithmetic mean (standard deviation)	-6 ( 9.4 )	-8.9 ( 9.2 )	-12 ( 8.3 )

Linear Regression

Statistical analysis description

The response variable was the change from baseline to the end of the double-blind treatment period in trough SBP.

Comparison groups

Atacand .05 mg v Atacand .20 mg v Atacand .40 mg

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

< 0.0136

Method

Regression, Linear

Parameter type

Mean difference (final values)

Point estimate

-0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-1.436

upper limit

-0.1692

Variability estimate

Standard deviation

Notes
[1] - The independent variables were dose ratio and weight group as a blocking factor.

Secondary: Mean change from baseline to week 4 in diastolic blood pressure (DBP)

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End point title

Mean change from baseline to week 4 in diastolic blood pressure (DBP)

End point description

End point type

Secondary

End point timeframe

From randomisation to end of double-blind treatment (4 weeks)

End point values	Atacand .05 mg	Atacand .20 mg	Atacand .40 mg
Number of subjects analysed	29	32	32
Units: mm Hg
arithmetic mean (standard deviation)	-5.2 ( 6.7 )	-7.9 ( 12.9 )	-11.1 ( 9.2 )

No statistical analyses for this end point

Secondary: Change in albumin/creatinine (A/C) ratio for each assigned dose level from baseline to Day 28

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End point title

Change in albumin/creatinine (A/C) ratio for each assigned dose level from baseline to Day 28

End point description

End point type

Secondary

End point timeframe

From randomisation to day 28

End point values	Atacand .05 mg	Atacand .20 mg	Atacand .40 mg
Number of subjects analysed	19	19	19
Units: Percent change
median (inter-quartile range (Q1-Q3))	-11.1 (-42.5 to 33.3)	-40.6 (-68.1 to 25)	-50 (-68.9 to 15.8)

No statistical analyses for this end point

Secondary: Change in protein/creatinine (P/C) ratio for each assigned dose level from baseline to Day 28

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End point title

Change in protein/creatinine (P/C) ratio for each assigned dose level from baseline to Day 28

End point description

End point type

Secondary

End point timeframe

From randomisation to day 28

End point values	Atacand .05 mg	Atacand .20 mg	Atacand .40 mg
Number of subjects analysed	25	26	27
Units: Percent change
median (inter-quartile range (Q1-Q3))	0 (-25 to 50)	-29.2 (-50 to 0)	0 (-40.7 to 0)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From randomisation (study day 0) to end of study (week 56).

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Atacand .05 mg

Reporting group description

candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose

Reporting group title

Atacand .20 mg

Reporting group description

candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose

Reporting group title

Atacand .40 mg

Reporting group description

candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose

Reporting group title

Open-Label

Reporting group description

Serious adverse events	Atacand .05 mg	Atacand .20 mg	Atacand .40 mg	Open-Label
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 29 (3.45%)	0 / 32 (0.00%)	1 / 32 (3.13%)	14 / 85 (16.47%)
number of deaths (all causes)	0	0	1	1
number of deaths resulting from adverse events	0	0	0	1
Injury, poisoning and procedural complications
Post procedural haemorrhage
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Vena Cava Thrombosis
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Catheter Site Haematoma
alternative dictionary used: MedDRA 11.0
subjects affected / exposed	1 / 29 (3.45%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Lymphadenitis cervical
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia drug
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	2 / 85 (2.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Catheter site necrosis
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
drug hypersensitivity
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Glomerulonephritis
Additional description: Chronic
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
Nephrotic Syndrome
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Urinary Tract Infection
alternative dictionary used: MedDRA 11.0
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	1 / 32 (3.13%)	3 / 85 (3.53%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
External ear cellulitis NOS
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia parainfluenzae viral
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis acute NOS
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Atacand .05 mg	Atacand .20 mg	Atacand .40 mg	Open-Label
Total subjects affected by non serious adverse events
subjects affected / exposed	18 / 29 (62.07%)	20 / 32 (62.50%)	18 / 32 (56.25%)	64 / 85 (75.29%)
Injury, poisoning and procedural complications
Excoriation
subjects affected / exposed	2 / 29 (6.90%)	0 / 32 (0.00%)	0 / 32 (0.00%)	1 / 85 (1.18%)
occurrences all number	2	0	0	1
Nervous system disorders
Headache
subjects affected / exposed	1 / 29 (3.45%)	3 / 32 (9.38%)	0 / 32 (0.00%)	5 / 85 (5.88%)
occurrences all number	1	3	0	5
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	4 / 29 (13.79%)	5 / 32 (15.63%)	4 / 32 (12.50%)	32 / 85 (37.65%)
occurrences all number	4	5	4	32
Fatigue
subjects affected / exposed	3 / 29 (10.34%)	1 / 32 (3.13%)	1 / 32 (3.13%)	3 / 85 (3.53%)
occurrences all number	3	1	1	3
Eye disorders
Conjunctivitis
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	1 / 32 (3.13%)	7 / 85 (8.24%)
occurrences all number	0	0	1	7
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	2 / 29 (6.90%)	3 / 32 (9.38%)	0 / 32 (0.00%)	12 / 85 (14.12%)
occurrences all number	2	3	0	12
Vomiting
subjects affected / exposed	2 / 29 (6.90%)	0 / 32 (0.00%)	0 / 32 (0.00%)	11 / 85 (12.94%)
occurrences all number	2	0	0	11
Abdominal pain
subjects affected / exposed	1 / 29 (3.45%)	1 / 32 (3.13%)	0 / 32 (0.00%)	5 / 85 (5.88%)
occurrences all number	1	1	0	5
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	2 / 29 (6.90%)	2 / 32 (6.25%)	4 / 32 (12.50%)	32 / 85 (37.65%)
occurrences all number	2	2	4	32
Rhinorrhoea
subjects affected / exposed	3 / 29 (10.34%)	2 / 32 (6.25%)	2 / 32 (6.25%)	12 / 85 (14.12%)
occurrences all number	3	2	2	12
Nasal congestion
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	5 / 85 (5.88%)
occurrences all number	0	0	0	5
Asthma
subjects affected / exposed	2 / 29 (6.90%)	0 / 32 (0.00%)	0 / 32 (0.00%)	2 / 85 (2.35%)
occurrences all number	2	0	0	2
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	2 / 29 (6.90%)	5 / 32 (15.63%)	3 / 32 (9.38%)	15 / 85 (17.65%)
occurrences all number	2	5	3	15
Nasopharyngitis
subjects affected / exposed	1 / 29 (3.45%)	1 / 32 (3.13%)	1 / 32 (3.13%)	15 / 85 (17.65%)
occurrences all number	1	1	1	15
Otitis media
subjects affected / exposed	0 / 29 (0.00%)	2 / 32 (6.25%)	0 / 32 (0.00%)	13 / 85 (15.29%)
occurrences all number	0	2	0	13
Urinary tract infection
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	2 / 32 (6.25%)	10 / 85 (11.76%)
occurrences all number	0	0	2	10
Bronchitis
subjects affected / exposed	1 / 29 (3.45%)	0 / 32 (0.00%)	0 / 32 (0.00%)	9 / 85 (10.59%)
occurrences all number	1	0	0	9
Pharyngitis
subjects affected / exposed	2 / 29 (6.90%)	0 / 32 (0.00%)	1 / 32 (3.13%)	6 / 85 (7.06%)
occurrences all number	2	0	1	6
Rhinitis
subjects affected / exposed	2 / 29 (6.90%)	0 / 32 (0.00%)	2 / 32 (6.25%)	7 / 85 (8.24%)
occurrences all number	2	0	2	7
Gastroenteritis
subjects affected / exposed	0 / 29 (0.00%)	0 / 32 (0.00%)	0 / 32 (0.00%)	6 / 85 (7.06%)
occurrences all number	0	0	0	6
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	2 / 29 (6.90%)	0 / 32 (0.00%)	0 / 32 (0.00%)	2 / 85 (2.35%)
occurrences all number	2	0	0	2

More information

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Were there any global substantial amendments to the protocol? Yes

20 Feb 2006

Centres have been added to reach enrolment goals

20 Jul 2007

Revision in blood pressure measurement.

12 Feb 2008

No interim analyses planned but amendment 2 provides the authorithy to analyse the double-blind dose response phase without waiting until long term open label phase is completed

12 Feb 2008

Echocardiography is added following recommendation from the Paediatric Committee at EMEA

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

http://www.ncbi.nlm.nih.gov/pubmed/20160654

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Clinical trials

Clinical Trial Results:
A Dose-ranging, Safety and Pharmacokinetics Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to Less Than 6 Years of Age: A 4-week, Multicenter, Randomized, Double-Blind Study with a 1-year Open-label, Follow-up Period

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Mean change from baseline to week 4 in systolic blood pressure (SBP)

Primary: Mean change from baseline to week 4 in systolic blood pressure (SBP)

Secondary: Mean change from baseline to week 4 in diastolic blood pressure (DBP)

Secondary: Mean change from baseline to week 4 in diastolic blood pressure (DBP)

Secondary: Change in albumin/creatinine (A/C) ratio for each assigned dose level from baseline to Day 28

Secondary: Change in albumin/creatinine (A/C) ratio for each assigned dose level from baseline to Day 28

Secondary: Change in protein/creatinine (P/C) ratio for each assigned dose level from baseline to Day 28

Secondary: Change in protein/creatinine (P/C) ratio for each assigned dose level from baseline to Day 28

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

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Clinical trials

Clinical Trial Results: A Dose-ranging, Safety and Pharmacokinetics Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to Less Than 6 Years of Age: A 4-week, Multicenter, Randomized, Double-Blind Study with a 1-year Open-label, Follow-up Period

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Mean change from baseline to week 4 in systolic blood pressure (SBP)

Primary: Mean change from baseline to week 4 in systolic blood pressure (SBP)

Secondary: Mean change from baseline to week 4 in diastolic blood pressure (DBP)

Secondary: Mean change from baseline to week 4 in diastolic blood pressure (DBP)

Secondary: Change in albumin/creatinine (A/C) ratio for each assigned dose level from baseline to Day 28

Secondary: Change in albumin/creatinine (A/C) ratio for each assigned dose level from baseline to Day 28

Secondary: Change in protein/creatinine (P/C) ratio for each assigned dose level from baseline to Day 28

Secondary: Change in protein/creatinine (P/C) ratio for each assigned dose level from baseline to Day 28

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
A Dose-ranging, Safety and Pharmacokinetics Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to Less Than 6 Years of Age: A 4-week, Multicenter, Randomized, Double-Blind Study with a 1-year Open-label, Follow-up Period