Trial | NCT00185185  Report issue

Title

Olmesartan Medoxomil in Atherosclerosis
Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    165
This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.
Study Started
Nov 30
2001
Study Completion
Feb 28
2006
Last Update
Dec 14
2007
Estimate

Drug Olmesartan medoxomil

Drug Atenolol

Drug Hydrochlorothiazide

tablets

Drug olmesartan medoxomil

tablets

Drug atenolol

tablets

1 Experimental

olmesartan medoxomil

2 Active Comparator

atenolol

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
No Results Posted