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The CLEVER Study - Coreg And Left Ventricular Mass Regression
This study has been completed.
Study NCT00108082   Information provided by GlaxoSmithKline
First Received: April 13, 2005   Last Updated: September 30, 2009   History of Changes

April 13, 2005
September 30, 2009
January 2005
 
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 ]
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 18 months of treatment.
Complete list of historical versions of study NCT00108082 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 1)To assess whether or not there is LV mass regression as measureed by LVMI on cardiac MRI after 9 months of treatment.
  • 2)LV mass regression by LVMI on echocardiogram after 9 and 18 months of treatment.
  • 3)Assessment of LV filling parameters.
 
The CLEVER Study - Coreg And Left Ventricular Mass Regression
See Detailed Description

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.

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).

Phase III
Interventional
Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
  • Hypertension
  • Left Ventricular Hypertrophy
  • Drug: carvedilol MR
  • Drug: atenolol
  • Drug: lisinopril
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
413
 
 

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00108082
Study Director, GSK
COR100216
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP