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Olmesartan Medoxomil in Atherosclerosis

Primary Purpose

Essential Hypertension, Atherosclerotic Cardiovascular Disease

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Olmesartan medoxomil
Atenolol
Hydrochlorothiazide
olmesartan medoxomil
atenolol
Sponsored by
Sankyo Pharma Gmbh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Mean sitting sBP and dBP prior to randomization of 140-180/90-105 mmHg Increased cardiovascular risk, e.g.: a) documented or clinical signs of peripheral atherosclerotic disease stage IIa or lower; b) diabetes mellitus type 2; c) left ventricular hypertrophy on echo; d) current smoking; e) old myocardial infarction, stroke or TIA Intima-media thickness of the common carotid artery greater than or equal to 0.8 and less than or equal to 1.6 mm (measured ultrasonographically) or the plaque volume of the carotid bulb greater than or equal to 4 μl and less than or equal to 500 μl Exclusion Criteria: Body mass index > 30 Any type of known secondary hypertension Electrocardiographic evidence of 2nd or 3rd degree atrioventricular block, atrial fibrillation, cardiac arrhythmia requiring therapy or bradycardia at rest (< 50/min) Obstructive pulmonary disease Claudicatio intermittens History or clinical evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial Hypersensitivity or contraindication to ARBs, Beta-Blockers, HCTZ or any cross allergy Pre-treatment with ARBs or ACE inhibitors within 6 months prior to screening Treatment with disallowed medication Pregnant or breastfeeding females or females of childbearing potential without adequate contraception History of alcohol and/or drug abuse

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

olmesartan medoxomil

atenolol

Outcomes

Primary Outcome Measures

Change of intima media thickness of the common carotid artery on the leading side of the neck.

Secondary Outcome Measures

-Change in plaque volume in the common carotid artery or the carotid bulb.
-Change of intima media thickness of the common carotid artery.
-Changes of diastolic and systolic blood pressure.
-Safety and tolerability

Full Information

First Posted
September 12, 2005
Last Updated
December 12, 2007
Sponsor
Sankyo Pharma Gmbh
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1. Study Identification

Unique Protocol Identification Number
NCT00185185
Brief Title
Olmesartan Medoxomil in Atherosclerosis
Official Title
Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sankyo Pharma Gmbh

4. Oversight

5. Study Description

Brief Summary
This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension, Atherosclerotic Cardiovascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
olmesartan medoxomil
Arm Title
2
Arm Type
Active Comparator
Arm Description
atenolol
Intervention Type
Drug
Intervention Name(s)
Olmesartan medoxomil
Intervention Type
Drug
Intervention Name(s)
Atenolol
Intervention Type
Drug
Intervention Name(s)
Hydrochlorothiazide
Intervention Description
tablets
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil
Intervention Description
tablets
Intervention Type
Drug
Intervention Name(s)
atenolol
Intervention Description
tablets
Primary Outcome Measure Information:
Title
Change of intima media thickness of the common carotid artery on the leading side of the neck.
Secondary Outcome Measure Information:
Title
-Change in plaque volume in the common carotid artery or the carotid bulb.
Title
-Change of intima media thickness of the common carotid artery.
Title
-Changes of diastolic and systolic blood pressure.
Title
-Safety and tolerability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mean sitting sBP and dBP prior to randomization of 140-180/90-105 mmHg Increased cardiovascular risk, e.g.: a) documented or clinical signs of peripheral atherosclerotic disease stage IIa or lower; b) diabetes mellitus type 2; c) left ventricular hypertrophy on echo; d) current smoking; e) old myocardial infarction, stroke or TIA Intima-media thickness of the common carotid artery greater than or equal to 0.8 and less than or equal to 1.6 mm (measured ultrasonographically) or the plaque volume of the carotid bulb greater than or equal to 4 μl and less than or equal to 500 μl Exclusion Criteria: Body mass index > 30 Any type of known secondary hypertension Electrocardiographic evidence of 2nd or 3rd degree atrioventricular block, atrial fibrillation, cardiac arrhythmia requiring therapy or bradycardia at rest (< 50/min) Obstructive pulmonary disease Claudicatio intermittens History or clinical evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial Hypersensitivity or contraindication to ARBs, Beta-Blockers, HCTZ or any cross allergy Pre-treatment with ARBs or ACE inhibitors within 6 months prior to screening Treatment with disallowed medication Pregnant or breastfeeding females or females of childbearing potential without adequate contraception History of alcohol and/or drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Klaus O Stumpe, MD
Organizational Affiliation
Medizinische Poliklinik der Friedrich-Wilhelms-Universitat, Bonn, Germany
Official's Role
Principal Investigator
Facility Information:
City
Munich
Country
Germany

12. IPD Sharing Statement

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Olmesartan Medoxomil in Atherosclerosis

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