Olmesartan Medoxomil in Atherosclerosis

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00185185
First received: September 12, 2005
Last updated: December 12, 2007
Last verified: December 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)

Resource links provided by NLM:


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
Experimental: 1
olmesartan medoxomil
Drug: Olmesartan medoxomil Drug: Hydrochlorothiazide
tablets
Drug: olmesartan medoxomil
tablets
Active Comparator: 2
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
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, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on July 20, 2014