Olmesartan Medoxomil in Atherosclerosis

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

Official Title
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Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)

Conditions
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Essential Hypertension, Atherosclerotic Cardiovascular Disease

Intervention / Treatment
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* Drug: Olmesartan medoxomil
* Drug: Atenolol
* Drug: Hydrochlorothiazide
* Drug: olmesartan medoxomil
* Drug: atenolol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>olmesartan medoxomil | Drug: Olmesartan medoxomil<br> <br> Drug: Hydrochlorothiazide<br>* tablets<br>Drug: olmesartan medoxomil<br>* tablets<br>|
| Active Comparator: 2<br>atenolol | Drug: Atenolol<br> <br> Drug: Hydrochlorothiazide<br>* tablets<br>Drug: atenolol<br>* tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of intima media thickness of the common carotid artery on the leading side of the neck. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -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 |  |  |