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

Sponsor:	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 MRI Scans

Drug Information available for: Atenolol Carvedilol Lisinopril

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Magnetic Resonance Imaging (MRI) at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the Last Observation Carried Forward [LOCF] analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was available) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in LV Mass as Measured by Echocardiography at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Mean Change From Baseline in LV Filling Parameters as Measured by MRI at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by MRI at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by Echocardiography at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used) ] [ Designated as safety issue: No ]
Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed B-type Natriuretic Peptide (BNP) at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF was used ] [ Designated as safety issue: No ]
Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed C-Reactive Protein (CRP) at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF was used) ] [ Designated as safety issue: No ]
Percentage Change From Baseline in Log Transformed Lipid Parameters at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF was used) ] [ Designated as safety issue: No ]
Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed Albumin Creatinine Ratio (ACR) at Month 12 [ Time Frame: Month 12 (If Month 12 data were not available, the LOCF was used) ] [ Designated as safety issue: No ]

Enrollment:	413
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
Results First Received:	August 13, 2009
Last Updated:	September 30, 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

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 November 25, 2009