Munich, Germany
NCT Number: NCT00185185
Olmesartan Medoxomil in Atherosclerosis
This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.
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Notify MeKey information
Conditions
Age range
35 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
olmesartan medoxomil
DrugAtenolol
DrugHydrochlorothiazide
Drugtablets
Primary outcomes
-
Change of intima media thickness of the common carotid artery on the leading side of the neck.
Secondary outcomes
-
-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
Sponsors and collaborators
Lead sponsor
Sankyo Pharma Gmbh
Industry
Registry information
Official study title
Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)
Important dates
- Study start
- 2001
- Study completion
- 2006
- First posted
- Sep 16, 2005
- Registry last updated
- Dec 14, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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