Olmesartan Medoxomil in Atherosclerosis

Essential Hypertension Clinical Trial

Official title:

Multi-Centre Olmesartan Atherosclerosis Regression Evaluation (MORE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185185
• Other study ID #: SE-866/27
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: December 12, 2007
• Start date: November 2001
• Est. completion date: February 2006

Study information

• Verified date: December 2007
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Essential Hypertension
• Hypertension

Intervention

Drug:
• Olmesartan medoxomil

• Atenolol

• Hydrochlorothiazide
tablets
• olmesartan medoxomil
tablets
• atenolol
tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sankyo Pharma Gmbh

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of intima media thickness of the common carotid artery on the leading side of the neck.
Secondary	-Change in plaque volume in the common carotid artery or the carotid bulb.
Secondary	-Change of intima media thickness of the common carotid artery.
Secondary	-Changes of diastolic and systolic blood pressure.
Secondary	-Safety and tolerability