Olmesartan Medoxomil in Atherosclerosis
Information source: Daiichi Sankyo Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Hypertension; Atherosclerotic Cardiovascular Disease
Intervention: Olmesartan medoxomil (Drug); Atenolol (Drug); Hydrochlorothiazide (Drug); olmesartan medoxomil (Drug); atenolol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sankyo Pharma Gmbh Official(s) and/or principal investigator(s):
Prof. Klaus O Stumpe, MD, Principal Investigator, Affiliation: Medizinische Poliklinik der Friedrich-Wilhelms-Universitat, Bonn, Germany
Summary
This is a study in hypertensive patients with atherosclerosis and increased cardiovascular
risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.
Clinical Details
Official title: Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change of intima media thickness of the common carotid artery on the leading side of the neck.
Secondary outcome: -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
Eligibility
Minimum age: 35 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Munich, Germany
Additional Information
Starting date: November 2001
Ending date: February 2006
Last updated: December 12, 2007
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