The CLEVER Study - Coreg And Left Ventricular Mass Regression

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hypertrophy, Left Ventricular

Treatments: Drug: carvedilol MR; Drug: lisinopril; Drug: atenolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00108082

COR100216

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 287 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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287 participants in 3 patient groups

Carvedilol CR

Experimental group

Description:

Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release \[MR\].)

Treatment:

Drug: lisinopril

Drug: carvedilol MR

Atenolol

Experimental group

Description:

Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.

Treatment:

Drug: lisinopril

Drug: atenolol

Lisinopril

Experimental group

Description:

Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.

Treatment:

Drug: lisinopril