Skip to main content
OpenTrials
Completed

NCT Number: NCT00185185

Olmesartan Medoxomil in Atherosclerosis

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Munich, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olmesartan medoxomil

Drug

Atenolol

Drug

Hydrochlorothiazide

Drug

tablets

Primary outcomes

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

Secondary outcomes

  1. -Change in plaque volume in the common carotid artery or the carotid bulb.

  2. -Change of intima media thickness of the common carotid artery.

  3. -Changes of diastolic and systolic blood pressure.

  4. -Safety and tolerability

Sponsors and collaborators

Lead sponsor

Sankyo Pharma Gmbh

Industry

Registry information

Official study title

Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)

Important dates

Study start
2001
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Dec 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.