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Olmesartan Medoxomil in Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00185185
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 14, 2007
Information provided by:
Daiichi Sankyo, Inc.

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

Condition or disease Intervention/treatment Phase
Essential Hypertension Atherosclerotic Cardiovascular Disease Drug: Olmesartan medoxomil Drug: Atenolol Drug: Hydrochlorothiazide Drug: olmesartan medoxomil Drug: atenolol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)
Study Start Date : November 2001
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
Experimental: 1
olmesartan medoxomil
Drug: Olmesartan medoxomil
Drug: Hydrochlorothiazide

Drug: olmesartan medoxomil

Active Comparator: 2
Drug: Atenolol
Drug: Hydrochlorothiazide

Drug: atenolol

Primary Outcome Measures :
  1. Change of intima media thickness of the common carotid artery on the leading side of the neck.

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00185185

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Munich, Germany
Sponsors and Collaborators
Sankyo Pharma Gmbh
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Principal Investigator: Prof. Klaus O Stumpe, MD Medizinische Poliklinik der Friedrich-Wilhelms-Universitat, Bonn, Germany

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Responsible Party: Petra Laeis, Daichi Sankyo Europe, GmbH Identifier: NCT00185185    
Other Study ID Numbers: SE-866/27
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 14, 2007
Last Verified: December 2007
Additional relevant MeSH terms:
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Essential Hypertension
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Olmesartan Medoxomil
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents