The CLEVER Study - Coreg And Left Ventricular Mass Regression

Condition(s) targeted: Hypertension; Left Ventricular Hypertrophy

Intervention: carvedilol MR (Drug); atenolol (Drug); lisinopril (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Modified Release Formulation (COREG MR) and Atenolol in Combination With and Compared to an Angiotensin Converting Enzyme Inhibitor (Lisinopril) on Left Ventricular Mass Regression in Hypertensive Patients With Left Ventricular Hypertrophy (LVH).

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To assess whether or not there is left ventricular (LV) mass regression as measured by left ventricular mass index (LVMI) on cardiac MRI in patients with hypertension and left ventricular hypertrophy after 12 months of treatment.

Secondary outcome: LV mass regression by LVMI on echocardiogram after 12 months of treatment; assessment of LV filling parameters.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

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Starting date: December 2004
Last updated: March 4, 2008