The CLEVER Study - Coreg And Left Ventricular Mass Regression
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).
1 other identifier
interventional
287
1 country
78
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2005
Typical duration for phase_3
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 13, 2005
CompletedFirst Posted
Study publicly available on registry
April 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
November 9, 2009
CompletedDecember 16, 2016
November 1, 2016
3.6 years
April 13, 2005
August 13, 2009
November 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
LVMI was measured by MRI at Baseline and after 12 months of treatment/Month 12. A reduction in left ventricular mass, calculated as LVMI, of 5 g/m\^2 was assumed to be clinically meaningful. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.
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 (13)
Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12
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
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
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
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
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)
- +8 more secondary outcomes
Study Arms (3)
Carvedilol CR
EXPERIMENTALCarvedilol 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 \[MR\].)
Atenolol
EXPERIMENTALAtenolol 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.
Lisinopril
EXPERIMENTALLisinopril 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.
Interventions
Study drug
Eligibility Criteria
You may qualify if:
- Stage 1 or Stage 2 hypertension.
- Left ventricular hypertrophy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (78)
GSK Investigational Site
Birmingham, Alabama, 35235, United States
GSK Investigational Site
Birmingham, Alabama, 35249, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Chandler, Arizona, 77030, United States
GSK Investigational Site
Mesa, Arizona, 85206, United States
GSK Investigational Site
Peoria, Arizona, 85381 - 4828, United States
GSK Investigational Site
Scottsdale, Arizona, 85251, United States
GSK Investigational Site
Scottsdale, Arizona, 85260, United States
GSK Investigational Site
Sun City, Arizona, 85351, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Los Angeles, California, 90033, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Los Angeles, California, 90095, United States
GSK Investigational Site
Palo Alto, California, 94301, United States
GSK Investigational Site
Poway, California, 92064, United States
GSK Investigational Site
Sacremento, California, 95819, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Leandro, California, 94578, United States
GSK Investigational Site
Santa Ana, California, 92705, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Colorado Springs, Colorado, 80919, United States
GSK Investigational Site
Denver, Colorado, 80204, United States
GSK Investigational Site
Denver, Colorado, 80218, United States
GSK Investigational Site
Newark, Delaware, 19718, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20037, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20422, United States
GSK Investigational Site
Altamonte Springs, Florida, 32714, United States
GSK Investigational Site
Atlantis, Florida, 33462, United States
GSK Investigational Site
Jacksonville, Florida, 32209, United States
GSK Investigational Site
Kissimmee, Florida, 34741, United States
GSK Investigational Site
Longwood, Florida, 32779, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Ormond Beach, Florida, 32714, United States
GSK Investigational Site
Pembroke Pines, Florida, 33029, United States
GSK Investigational Site
Evanston, Illinois, 60201, United States
GSK Investigational Site
Vernon Hills, Illinois, 60061, United States
GSK Investigational Site
Fort Wayne, Indiana, 46804, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Scarborough, Maine, 04074, United States
GSK Investigational Site
Baltimore, Maryland, 21224, United States
GSK Investigational Site
Columbia, Maryland, 21044, United States
GSK Investigational Site
Pikesville, Maryland, 21215, United States
GSK Investigational Site
Grand Rapids, Michigan, 49525, United States
GSK Investigational Site
Edina, Minnesota, 55435, United States
GSK Investigational Site
Minneapolis, Minnesota, 55417, United States
GSK Investigational Site
Camden, New Jersey, 08103, United States
GSK Investigational Site
Buffalo, New York, 14215, United States
GSK Investigational Site
New York, New York, 10011, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
New York, New York, 10128, United States
GSK Investigational Site
Williamsville, New York, 14221, United States
GSK Investigational Site
Fayetteville, North Carolina, 28304, United States
GSK Investigational Site
Greensboro, North Carolina, 27401, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27157, United States
GSK Investigational Site
Cincinnati, Ohio, 45224, United States
GSK Investigational Site
Cincinnati, Ohio, 45267, United States
GSK Investigational Site
Cleveland, Ohio, 44122, United States
GSK Investigational Site
Hillsboro, Oregon, 97123-4117, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Allentown, Pennsylvania, 18105, United States
GSK Investigational Site
Camp Hill, Pennsylvania, 17011, United States
GSK Investigational Site
Doylestown, Pennsylvania, 18901, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212, United States
GSK Investigational Site
West Grove, Pennsylvania, 19390, United States
GSK Investigational Site
Warwick, Rhode Island, 02886, United States
GSK Investigational Site
Columbia, South Carolina, 29204, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Knoxville, Tennessee, 37920, United States
GSK Investigational Site
Nashville, Tennessee, 37205, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Danville, Virginia, 24541, United States
GSK Investigational Site
Roanoke, Virginia, 24014, United States
GSK Investigational Site
Springfield, Virginia, 22151, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53215, United States
Related Publications (2)
Bakris GL, Tarka EA, Waterhouse B, Goulding MR, Madan A, Anderson KM, St John Sutton M, Miller AB, Reichek N. 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 Oct 2;98(7A):46L-52L. doi: 10.1016/j.amjcard.2006.08.002. Epub 2006 Aug 28.
PMID: 17023232BACKGROUNDMiller AB, Reichek N, St John Sutton M, Iyengar M, Henderson LS, Tarka EA, Bakris GL. Importance of blood pressure control in left ventricular mass regression. J Am Soc Hypertens. 2010 Nov-Dec;4(6):302-10. doi: 10.1016/j.jash.2010.09.003. Epub 2010 Oct 27.
PMID: 20980215BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2005
First Posted
April 14, 2005
Study Start
January 1, 2005
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
December 16, 2016
Results First Posted
November 9, 2009
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.