Olmesartan Medoxomil in Atherosclerosis

Phase 3

Completed

• Conditions: Essential Hypertension; Atherosclerotic Cardiovascular Disease
• Interventions: Drug: olmesartan medoxomil; Drug: atenolol; Drug: Hydrochlorothiazide

• Registration Number: NCT00185185
• Lead Sponsor: Sankyo Pharma Gmbh

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Study Completion: 2006-02
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-12
• Last Update Posted: 2007-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	olmesartan medoxomil	olmesartan medoxomil
1	Hydrochlorothiazide	olmesartan medoxomil
2	atenolol	atenolol
2	Hydrochlorothiazide	atenolol

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
-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