Last updated: 11/04/2018 05:57:56
The CLEVER Study - Coreg And Left Ventricular Mass Regression
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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).
Trial 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: Baseline and 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)
Secondary outcomes:
Model-adjusted Mean Change from Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12
Timeframe: Baseline and 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)
Model-adjusted Mean Change from Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12
Timeframe: Baseline and 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)
Model-adjusted Mean Change from Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12
Timeframe: Baseline and 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)
Model-adjusted Mean Change from Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12
Timeframe: Baseline and 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)
Model-adjusted Mean Change from Baseline in LV Mass as Measured by Echocardiography at Month 12
Timeframe: Baseline and 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)
Mean change from Baseline in LV Filling Parameters as Measured by MRI at Month 12
Timeframe: Baseline and 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)
Model-adjusted Mean Change from Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by MRI at Month 12
Timeframe: Baseline and 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)
Model-adjusted Mean Change from Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by Echocardiography at Month 12
Timeframe: Baseline and 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)
Model-adjusted Mean Change from Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12
Timeframe: Baseline and 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)
Model-adjusted Ratio to Baseline as Percentage Change from Baseline in Log Transformed B-type Natriuretic Peptide (BNP) at Month 12
Timeframe: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used
Model-adjusted Ratio to Baseline as Percentage Change from Baseline in Log Transformed C-Reactive Protein (CRP) at Month 12
Timeframe: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)
Percentage Change from Baseline in Log Transformed Lipid Parameters at Month 12
Timeframe: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)
Model-adjusted Ratio to Baseline as Percentage Change from Baseline in Log Transformed Albumin Creatinine Ratio (ACR) at Month 12
Timeframe: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)
Interventions:
Drug: carvedilol MR
Drug: atenolol
Drug: lisinopril
Enrollment:
287
Observational study model:
Not applicable
Primary completion date:
2008-19-08
Time perspective:
Not applicable
Clinical publications:
Bakris GL et al. Cardiovascular Risk Factors in Hypertension: Rationale and Design of Studies to Investigate the Effects of Controlled-release Carvedilol on Regression of Left Ventricular Hypertrophy and Lipid Profile. Am J Cardiol 2006; 98:46L-52L
Miller A, Reichek N, St. John Sutton M, Iyengar M, Henderson L, Tarka E, Bakris G. Importance of Blood Pressure Control in Left Ventricular Mass Regression. [J Am Soc Hypertens]. 2010;4(6):302-310.
Miller A, Reichek N, St. John Sutton M, Iyengar M, Henderson L, Tarka E, Bakris G. Importance of Blood Pressure Control in Left Ventricular Mass Regression. J Am Soc Hypertens. 2010;4(6):302-310.
Medical condition
Hypertrophy, Left Ventricular
Product
carvedilol
Collaborators
Not applicable
Study date(s)
January 2005 to August 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 80 years
Accepts healthy volunteers
No
- Stage 1 or Stage 2 hypertension.
- Left ventricular hypertrophy.
- In atrial fibrillation.
- Takes beta-blocker for MI (myocardial infarction) or arrhythmia.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Atlantis, Florida, United States, 33462
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10128
Status
Study Complete
Location
GSK Investigational Site
Allentown, Pennsylvania, United States, 18105
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Santa Ana, California, United States, 92705
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 77030
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80204
Status
Study Complete
Location
GSK Investigational Site
Newark, Delaware, United States, 19718
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35235
Status
Study Complete
Location
GSK Investigational Site
Scarborough, Maine, United States, 04074
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21224
Status
Study Complete
Location
GSK Investigational Site
Roanoke, Virginia, United States, 24014
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45267
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sacremento, California, United States, 95819
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44122
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hillsboro, Oregon, United States, 97123-4117
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80218
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90033
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mobile, Alabama, United States, 36608
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20037
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10011
Status
Study Complete
Location
GSK Investigational Site
Poway, California, United States, 92064
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215
Status
Study Complete
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46804
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Williamsville, New York, United States, 14221
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Doylestown, Pennsylvania, United States, 18901
Status
Study Complete
Location
GSK Investigational Site
Palo Alto, California, United States, 94301
Status
Study Complete
Location
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14215
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20422
Status
Study Complete
Location
GSK Investigational Site
Edina, Minnesota, United States, 55435
Status
Study Complete
Location
GSK Investigational Site
San Leandro, California, United States, 94578
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Location
GSK Investigational Site
Springfield, Virginia, United States, 22151
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29204
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80919
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Sun City, Arizona, United States, 85351
Status
Study Complete
Location
GSK Investigational Site
Ormond Beach, Florida, United States, 32714
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32209
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Evanston, Illinois, United States, 60201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Camp Hill, Pennsylvania, United States, 17011
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Altamonte Springs, Florida, United States, 32714
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pikesville, Maryland, United States, 21215
Status
Study Complete
Location
GSK Investigational Site
West Grove, Pennsylvania, United States, 19390
Status
Study Complete
Location
GSK Investigational Site
Kissimmee, Florida, United States, 34741
Status
Study Complete
Location
GSK Investigational Site
Vernon Hills, Illinois, United States, 60061
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Camden, New Jersey, United States, 08103
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85260
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45224
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
Status
Study Complete
Location
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbia, Maryland, United States, 21044
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Study Complete
Location
GSK Investigational Site
Danville, Virginia, United States, 24541
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35249
Status
Study Complete
Location
GSK Investigational Site
Fayetteville, North Carolina, United States, 28304
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55417
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Longwood, Florida, United States, 32779
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33029
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Grand Rapids, Michigan, United States, 49525
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-19-08
Actual study completion date
2008-19-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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