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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.
ClinicalTrials.gov Identifier: NCT00185185
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 14, 2007
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

September 12, 2005
September 16, 2005
December 14, 2007
November 2001
Not Provided
Change of intima media thickness of the common carotid artery on the leading side of the neck.
Same as current
Complete list of historical versions of study NCT00185185 on ClinicalTrials.gov Archive Site
  • -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
Same as current
Not Provided
Not Provided
 
Olmesartan Medoxomil in Atherosclerosis
Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)
This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Essential Hypertension
  • Atherosclerotic Cardiovascular Disease
  • Drug: Olmesartan medoxomil
  • Drug: Atenolol
  • Drug: Hydrochlorothiazide
    tablets
  • Drug: olmesartan medoxomil
    tablets
  • Drug: atenolol
    tablets
  • Experimental: 1
    olmesartan medoxomil
    Interventions:
    • Drug: Olmesartan medoxomil
    • Drug: Hydrochlorothiazide
    • Drug: olmesartan medoxomil
  • Active Comparator: 2
    atenolol
    Interventions:
    • Drug: Atenolol
    • Drug: Hydrochlorothiazide
    • Drug: atenolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
128
February 2006
Not Provided

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
Sexes Eligible for Study: All
35 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00185185
SE-866/27
Not Provided
Not Provided
Not Provided
Petra Laeis, Daichi Sankyo Europe, GmbH
Sankyo Pharma Gmbh
Not Provided
Principal Investigator: Prof. Klaus O Stumpe, MD Medizinische Poliklinik der Friedrich-Wilhelms-Universitat, Bonn, Germany
Daiichi Sankyo, Inc.
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP