The CLEVER Study - Coreg And Left Ventricular Mass Regression

Completed · Phase 3

Conditions studied: Hypertrophy, Left Ventricular

In brief

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.

Key facts

Study ID

NCT00108082

Run by

GlaxoSmithKline

People needed

287

Starts

2005-01-01

Expected to finish

2008-08-01

Last updated by the study team

2016-12-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stage 1 or Stage 2 hypertension.
• Left ventricular hypertrophy.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Peoria, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Sun City, Arizona, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Palo Alto, California, United States
• GSK Investigational Site — Poway, California, United States
• GSK Investigational Site — Sacremento, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Leandro, California, United States
• GSK Investigational Site — Santa Ana, California, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Newark, Delaware, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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