Olmesartan Medoxomil in Atherosclerosis

Official Title: “Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)”

This is a study in hypertensive patients with atherosclerosis and increased cardiovascular risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.

Intervention(s) in this Clinical Trial

• Drug: Olmesartan medoxomil
• Drug: Atenolol
• Drug: Hydrochlorothiazide
  • tablets
• Drug: olmesartan medoxomil
  • tablets
• Drug: atenolol
  • tablets

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • olmesartan medoxomil
• Active Comparator: 2
  • atenolol

Primary Measures

• Change of intima media thickness of the common carotid artery on the leading side of the neck.

Secondary 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sankyo Pharma Gmbh Industry

Overall Clinical Trial Officials and Contacts

Prof. Klaus O Stumpe, MD Principal Investigator Medizinische Poliklinik der Friedrich-Wilhelms-Universitat, Bonn, Germany  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00185185

Study ID Number: SE-866/27

ClinicalTrials.gov Identifier: NCT00185185

Health Authority: Germany: Federal Institute for Drugs and Medical Devices