Olmesartan Medoxomil in Atherosclerosis - Full Text View

Sponsor:	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

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:

MedlinePlus related topics: Atherosclerosis High Blood Pressure

Drug Information available for: Hydrochlorothiazide Atenolol Olmesartan Olmesartan medoxomil

U.S. FDA Resources

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

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:

Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Hypertension
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 February 09, 2012