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Olmesartan Medoxomil in Atherosclerosis
This study has been completed.
Sponsored by: Sankyo Pharma Gmbh
Information provided by: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00185185
  Purpose

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


Condition Intervention Phase
Essential Hypertension
Atherosclerotic Cardiovascular Disease
Drug: Olmesartan medoxomil
Drug: Atenolol
Drug: Hydrochlorothiazide
Drug: olmesartan medoxomil
Drug: atenolol
Phase III

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Hydrochlorothiazide Atenolol Olmesartan Olmesartan medoxomil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)

Further study details as provided by Daiichi Sankyo Inc.:

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

Secondary Outcome Measures:
  • -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

Enrollment: 165
Study Start Date: November 2001
Study Completion Date: February 2006
Arms Assigned Interventions
1: Experimental
olmesartan medoxomil
Drug: Olmesartan medoxomil Drug: Hydrochlorothiazide
tablets
Drug: olmesartan medoxomil
tablets
2: Active Comparator
atenolol
Drug: Atenolol Drug: Hydrochlorothiazide
tablets
Drug: atenolol
tablets

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185185

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

Responsible Party: Daichi Sankyo Europe, GmbH ( Petra Laeis )
Study ID Numbers: SE-866/27
Study First Received: September 12, 2005
Last Updated: December 12, 2007
ClinicalTrials.gov Identifier: NCT00185185  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Olmesartan medoxomil
Essential hypertension
Arteriosclerosis
Angiotensin II
Atenolol
Hydrochlorothiazide
Hypertension

Additional relevant MeSH terms:
Sympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sodium Chloride Symporter Inhibitors
Diuretics
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009