The CLEVER Study - Coreg And Left Ventricular Mass Regression

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to compare the effects of COREG MR (carvedilol modified release formulation) to atenolol on indices of left ventricular dimensions when added to standardized angiotensin converting enzyme (ACE) inhibition, and to the effect of ACE inhibition alone. Subjects with LVH (left ventricular hypertrophy) and hypertension will be studied. The primary endpoint will be the change in left ventricular mass index (LVMI) characterized by magnetic resonance imaging (MRI) following 12 months of treatment. Secondary endpoints include the change in LV (left ventricular) mass, LV wall thickness, diastolic left ventricular filling parameters, and left ventricular ejection fraction by echocardiographic methods at Treatment Month 12. Composite outcomes and individual event data will also be evaluated by treatment group.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Atenolol; Carvedilol; Lisinopril

Criteria

Inclusion criteria:

• Stage 1 or Stage 2 hypertension.

• Left ventricular hypertrophy.

Exclusion criteria:

• In atrial fibrillation.

• Takes beta-blocker for MI (myocardial infarction) or arrhythmia.

• Has uncontrolled diabetes, uncontrollable or symptomatic arrhythmias, unstable angina, second or third degree heart block, history of MI, COPD (chronic obstructive pulmonary disease), liver or kidney disease.

• Uses beta-2-agonists.

• Unable to undergo MRI (magnetic resonance imaging).

• Females of childbearing potential.