Status:
COMPLETED
Olmesartan Medoxomil in Atherosclerosis
Lead Sponsor:
Sankyo Pharma Gmbh
Conditions:
Essential Hypertension
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
35-75 years
Phase:
PHASE3
Brief Summary
This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00185185
Start Date
November 1 2001
End Date
February 1 2006
Last Update
December 14 2007
Active Locations (1)
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1
Munich, Germany