The CLEVER Study - Coreg And Left Ventricular Mass Regression - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00108082

Purpose

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.

Condition	Intervention	Phase
Hypertension Left Ventricular Hypertrophy	Drug: carvedilol MR Drug: atenolol Drug: lisinopril	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Atenolol Carvedilol Lisinopril

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	220
Study Start Date:	January 2005

Detailed 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).

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108082

Show 57 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	COR100216
Study First Received:	April 13, 2005
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00108082 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

left ventricular hypertrophy (LVH)
left ventricular mass regression
left ventricular mass index (LVMI)hypertension
cardiac MRI
echocardiogram

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hypertrophy, Left Ventricular
Vasodilator Agents
Neurotransmitter Agents
Heart Diseases
Adrenergic Agents
Lisinopril
Vascular Diseases
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents

Protease Inhibitors
Hypertrophy
Angiotensin-Converting Enzyme Inhibitors
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Atenolol
Cardiomegaly
Hypertension
Carvedilol

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Carvedilol
Hypertrophy, Left Ventricular
Sympatholytics

Heart Diseases
Lisinopril
Vascular Diseases
Enzyme Inhibitors
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Hypertrophy
Autonomic Agents
Adrenergic Antagonists
Peripheral Nervous System Agents
Atenolol

ClinicalTrials.gov processed this record on September 03, 2009