Last updated: 11/04/2018 05:57:56

The CLEVER Study - Coreg And Left Ventricular Mass Regression

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GSK study ID
COR100216
See study documents
Clinicaltrials.gov ID
NCT00108082
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2008-19-08
    Observational study model:
    Not applicable
    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
    • Inclusion criteria:
    • Stage 1 or Stage 2 hypertension.
    Inclusion and exclusion criteria
    Inclusion 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
    Status
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    Location
    GSK Investigational Site
    Atlantis, Florida, United States, 33462
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10128
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Allentown, Pennsylvania, United States, 18105
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Santa Ana, California, United States, 92705
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chandler, Arizona, United States, 77030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15212
    Status
    Study Complete
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    Showing 1 - 6 of 78 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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.

    Additional information about the trial

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