Olmesartan Medoxomil in Atherosclerosis

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sankyo Pharma Gmbh
• Treatments: Atenolol; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil

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