Clinical Trials Register

Summary
EudraCT Number:	2007-003131-23
Sponsor's Protocol Code Number:	DSE-866/47
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-05-21
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2007-003131-23

A.3

Full title of the trial

Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects with Metabolic Syndrome

A.4.1

Sponsor's protocol code number

DSE-866/47

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	DAIICHI SANKYO EUROPE GmbH
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Olmetec
D.2.1.1.2	Name of the Marketing Authorisation holder	Daiichi Sanykyo Europe GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Olmesartan medoxomil
D.3.2	Product code	CS-866
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Olmesartan Medoxomil
D.3.9.1	CAS number	144689-63-4
D.3.9.2	Current sponsor code	CS-866
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Olmetec
D.2.1.1.2	Name of the Marketing Authorisation holder	Daiichi Sanykyo Europe GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Olmesartan medoxomil
D.3.2	Product code	CS-866
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Olmesartan Medoxomil
D.3.9.1	CAS number	144689-63-4
D.3.9.2	Current sponsor code	CS-866
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Metabolic Syndrome, Hypertension

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10052066
E.1.2	Term	Metabolic syndrome

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10020772
E.1.2	Term	Hypertension

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To investigate in a descriptive way the dose-dependent effect of OM 20 mg, 40 mg, and 80 mg on aortic stiffness assessed by
• The change from baseline in carotid-femoral Pulse Wave Velocity (PWV) after 52 weeks of double-blind treatment
• The change from baseline in carotid-femoral PWV, after adjustment for change from baseline in Mean Blood Pressure (MBP) after 52 weeks of double-blind treatment

E.2.2

Secondary objectives of the trial

To investigate in a descriptive way the dose-dependent effect of OM 20 mg, 40 mg, and 80 mg
• The change from baseline in carotid-femoral Pulse Wave Velocity (PWV) after 24 weeks of double-blind treatment
• The change from baseline in carotid-femoral PWV, after adjustment for change from baseline in Mean Blood Pressure (MBP) after 24 weeks of double-blind treatment
• On Blood Pressure (BP) lowering, assessed by conventional BP measurement and 24h Ambulatory BP Measurement (24h-ABPM) after 52 and 24 weeks of double-blind treatment
• On central Pulse Pressure (PP) and Augmentation Index (AI) after 52 and 24weeks of double-blind treatment
• On common carotid stiffness, Intima-Media Thickness (IMT), and internal diameter after 52 and 24weeks of double-blind treatment.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects must satisfy all of the following criteria at Screening visit (Visit 1) and at Baseline (Visit 2) to be included in the study; except inclusion criterion 3, which needs only be satisfied at the Screening visit:

1. Male and female outpatients
2. Age ≥ 18 and ≤ 75 years
3. Hypertension and metabolic syndrome defined, according to the ATP III/ IDF 2005 and ESH/ESC 2007 definitions with modifications, as:
a) BP ≥ 130/85 mmHg and < 150/95 mmHg (ie untreated high normal BP or “low range” mild hypertension) and at least 1 of the following traits:
• Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)
• Triglyceride level ≥ 150 mg/dL
• High Density Lipoprotein (HDL) < 40 mg/dL for men and < 50 mg/dL for women
• Fasting blood glucose ≥ 110 mg/dL and < 126 mg/dL (ie no type 2 diabetes)
Or
b) BP ≥ 120/80 mmHg and < 130/85 mmHg (ie normal BP) and one antihypertensive treatment at Screening, and normal to “low range” mild hypertension (ie ≥ 130/85 and < 150/95 mmHg) at Baseline, and at least 1 of the following traits:
• Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)
• Triglyceride level ≥ 150 mg/dL
• High Density Lipoprotein (HDL) < 40 mg/dL for men and < 50 mg/dL for women
• Fasting blood glucose ≥ 110 mg/dL and < 126 mg/dL (ie no type 2 diabetes)
Or
c) BP ≥ 130/85 mmHg and < 150/95 mmHg (ie untreated high normal BP or “low range” mild hypertension) and current treatment with a lipid-lowering agent and at least 1 of the following traits:
• Abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)
• Fasting blood glucose ≥ 110 mg/dL and < 126 mg/dL (ie no type 2 diabetes)
4. No anti-hypertensive treatment or treatment with only one anti-hypertensive medication within the last 3 months (including ACE, ARB and renin-inhibitors).
5. Signature of the Informed Consent Form (ICF)

E.4

Principal exclusion criteria

Subjects who meet any one of the following criteria at Screening visit (Visit 1) or at Baseline (Visit 2) will be disqualified from entering the study:

1. Females who are pregnant or plan a pregnancy during the time of the trial, are nursing, or are of childbearing potential and not using adequate and highly effective methods of contraception prior to and during the study.
Note: a female of non-childbearing potential will be defined as one who has been postmenopausal for at least one year or has been surgically sterilized or had a hysterectomy at least three months prior to the start of the study (Visit 1); adequate and highly effective method of contraception is defined as those resulting in a low failure rate (i.e. less than 1% per year) when used correctly and consistently, such as implants, injectables, combined oral contraceptives, hormonal intra-uterine devices, sexual abstinence, or vasectomised partner. The investigator will inform the applicable female patients about the respective method(s) in detail prior to study start. If a female becomes pregnant during the study, she has to be withdrawn immediately.
2. Type 1 and type 2 diabetes
3. “High range” mild hypertension (ie Systolic Blood Pressure [SBP]: 150 - < 160 mmHg and/or Diastolic Blood Pressure [DBP]: 95 - < 100 mmHg)
4. Moderate, severe, or resistant hypertension (see definitions below)
SBP (mmHg) DBP (mmHg)
Moderate hypertension 160 – 179 and/or 100 – 109
Severe hypertension ≥ 180 and/or ≥ 110
Resistant hypertension Hypertension resistant to treatment
5. Secondary hypertension of any aetiology, such as renal disease, pheocromocytoma, or Cushing’s syndrome
6. Serious disorders which may limit the ability to evaluate the efficacy or safety of the study drug, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine, metabolic, haematological, oncological, neurological, or psychiatric diseases
7. History of the following pathologies within the last 6 months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, hypertensive encephalopathy, stroke, or transient ischemic attack
8. Clinically relevant abnormal laboratory values
9. Contraindication to OM
10. Previously screened subjects, unless they failed inclusion criterion 3 at screening and/or baseline under earlier protocol requirements.
11. Alcohol or drug of abuse in the past 2 years
12. Planned hospitalization during the study period
13. Participation in any other clinical study within 30 days prior to Screening visit
14. Enrolment of the Investigator(s), site staff, or their family members

E.5 End points

E.5.1

Primary end point(s)

Primary efficacy endpoint
Change from baseline in carotid-femoral PWV at Week 52.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

compare 3 different doses (20mg, 40mg and 80mg)

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	7
F.4.2	For a multinational trial
F.4.2.1	In the EEA	264
F.4.2.2	In the whole clinical trial	264

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2008-09-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-06-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-08-08

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