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Trial record 45 of 116 for:    Atenolol

The CLEVER Study - Coreg And Left Ventricular Mass Regression

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ClinicalTrials.gov Identifier: NCT00108082
Recruitment Status : Completed
First Posted : April 14, 2005
Results First Posted : November 9, 2009
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Hypertrophy, Left Ventricular Drug: carvedilol MR Drug: atenolol Drug: lisinopril Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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).
Study Start Date : January 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Carvedilol CR
Carvedilol 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].)
Drug: carvedilol MR
Study drug
Other Name: Carvedilol controlled release or modified release

Drug: lisinopril
Comparator
Other Names:
  • carvedilol MR
  • atenolol

Experimental: Atenolol
Atenolol 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.
Drug: atenolol
Comparator

Drug: lisinopril
Comparator
Other Names:
  • carvedilol MR
  • atenolol

Experimental: Lisinopril
Lisinopril 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.
Drug: lisinopril
Comparator
Other Names:
  • carvedilol MR
  • atenolol




Primary Outcome Measures :
  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 [ Time Frame: 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) ]
    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.


Secondary Outcome Measures :
  1. Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12 [ Time Frame: 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) ]
    LVMIH was measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. LV mass depends on body size. One method of determining whether an individual has LV hypertrophy relates LV mass to height raised to a power of 2.7.

  2. Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12 [ Time Frame: 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) ]
    LV Mass was measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.

  3. 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: 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) ]
    LVMI was measured by echogradiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.

  4. Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12 [ Time Frame: 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) ]
    LVMIH was measured by echogradiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.

  5. Model-adjusted Mean Change From Baseline in LV Mass as Measured by Echocardiography at Month 12 [ Time Frame: 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) ]
    LV Mass was measured by echocardiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.

  6. Mean Change From Baseline in LV Filling Parameters as Measured by MRI at Month 12 [ Time Frame: 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) ]
    LV filling parameters, LV E-Volume and LV A-Volume, were measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. These filling parameters represent the volumes of blood filling the ventricle during the passive filling phase (E-volume) and the active filling phase caused by atrial contraction (A-volume).

  7. 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: 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) ]
    LV End Systolic and Diastolic Volumes and Ejection Fraction were measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. The ejection fraction is the fraction of the blood volume available at the end of diastole that is pumped out of the ventricules during systole.

  8. 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: 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) ]
    LV End Systolic and Diastolic Volumes and Ejection Fraction were measured by echocardiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.

  9. Model-adjusted Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12 [ Time Frame: 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) ]
    Systolic and Diastolic BP were measured at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.

  10. Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed B-type Natriuretic Peptide (BNP) at Month 12 [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used ]
    BNP concentration (picagram per milliter) was measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and was calculated as 100 x (exponent (mean change on log scale) -1) [Change is the Month 12 value (or value after 12 months of treatment) minus the Baseline value].

  11. Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed C-Reactive Protein (CRP) at Month 12 [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used) ]
    CRP concentration (milligrams per deciliter) was measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and calculated as 100 x (exponent (mean change on log scale) - 1). [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]

  12. Percentage Change From Baseline in Log Transformed Lipid Parameters at Month 12 [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used) ]
    Plasma lipid concentrations (milligrams per deciliter) were measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and calculated as 100 x (exponent(mean change on log scale) - 1). [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]

  13. Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed Albumin Creatinine Ratio (ACR) at Month 12 [ Time Frame: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used) ]
    Urinary ACR (micrograms per milligram) was determined at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and was calculated as 100 x (exponent (exponent (mean change on log scale) - 1. [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108082


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Locations
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United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35235
GSK Investigational Site
Birmingham, Alabama, United States, 35249
GSK Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 77030
GSK Investigational Site
Mesa, Arizona, United States, 85206
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
GSK Investigational Site
Scottsdale, Arizona, United States, 85260
GSK Investigational Site
Sun City, Arizona, United States, 85351
United States, California
GSK Investigational Site
Fresno, California, United States, 93720
GSK Investigational Site
Los Angeles, California, United States, 90033
GSK Investigational Site
Los Angeles, California, United States, 90048
GSK Investigational Site
Los Angeles, California, United States, 90095
GSK Investigational Site
Palo Alto, California, United States, 94301
GSK Investigational Site
Poway, California, United States, 92064
GSK Investigational Site
Sacremento, California, United States, 95819
GSK Investigational Site
San Diego, California, United States, 92120
GSK Investigational Site
San Leandro, California, United States, 94578
GSK Investigational Site
Santa Ana, California, United States, 92705
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
GSK Investigational Site
Colorado Springs, Colorado, United States, 80919
GSK Investigational Site
Denver, Colorado, United States, 80204
GSK Investigational Site
Denver, Colorado, United States, 80218
United States, Delaware
GSK Investigational Site
Newark, Delaware, United States, 19718
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20037
GSK Investigational Site
Washington, District of Columbia, United States, 20422
United States, Florida
GSK Investigational Site
Altamonte Springs, Florida, United States, 32714
GSK Investigational Site
Atlantis, Florida, United States, 33462
GSK Investigational Site
Jacksonville, Florida, United States, 32209
GSK Investigational Site
Kissimmee, Florida, United States, 34741
GSK Investigational Site
Longwood, Florida, United States, 32779
GSK Investigational Site
Miami, Florida, United States, 33156
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Ormond Beach, Florida, United States, 32714
GSK Investigational Site
Pembroke Pines, Florida, United States, 33029
United States, Illinois
GSK Investigational Site
Evanston, Illinois, United States, 60201
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Vernon Hills, Illinois, United States, 60061
United States, Indiana
GSK Investigational Site
Fort Wayne, Indiana, United States, 46804
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maine
GSK Investigational Site
Scarborough, Maine, United States, 04074
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21224
GSK Investigational Site
Columbia, Maryland, United States, 21044
GSK Investigational Site
Pikesville, Maryland, United States, 21215
United States, Michigan
GSK Investigational Site
Grand Rapids, Michigan, United States, 49525
United States, Minnesota
GSK Investigational Site
Edina, Minnesota, United States, 55435
GSK Investigational Site
Minneapolis, Minnesota, United States, 55417
United States, New Jersey
GSK Investigational Site
Camden, New Jersey, United States, 08103
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14215
GSK Investigational Site
New York, New York, United States, 10011
GSK Investigational Site
New York, New York, United States, 10021
GSK Investigational Site
New York, New York, United States, 10128
GSK Investigational Site
Williamsville, New York, United States, 14221
United States, North Carolina
GSK Investigational Site
Fayetteville, North Carolina, United States, 28304
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45224
GSK Investigational Site
Cincinnati, Ohio, United States, 45267
GSK Investigational Site
Cleveland, Ohio, United States, 44122
United States, Oregon
GSK Investigational Site
Hillsboro, Oregon, United States, 97123-4117
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
GSK Investigational Site
Allentown, Pennsylvania, United States, 18105
GSK Investigational Site
Camp Hill, Pennsylvania, United States, 17011
GSK Investigational Site
Doylestown, Pennsylvania, United States, 18901
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
GSK Investigational Site
West Grove, Pennsylvania, United States, 19390
United States, Rhode Island
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29204
GSK Investigational Site
Greenville, South Carolina, United States, 29615
GSK Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
GSK Investigational Site
Nashville, Tennessee, United States, 37205
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
GSK Investigational Site
Danville, Virginia, United States, 24541
GSK Investigational Site
Roanoke, Virginia, United States, 24014
GSK Investigational Site
Springfield, Virginia, United States, 22151
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: COR100216
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: COR100216
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: COR100216
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: COR100216
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: COR100216
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: COR100216
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: COR100216
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00108082     History of Changes
Other Study ID Numbers: COR100216
First Posted: April 14, 2005    Key Record Dates
Results First Posted: November 9, 2009
Last Update Posted: December 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
left ventricular hypertrophy (LVH)
echocardiogram
left ventricular mass regression
cardiac MRI
left ventricular mass index (LVMI)hypertension
Additional relevant MeSH terms:
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Atenolol
Hypertrophy, Left Ventricular
Hypertrophy
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Carvedilol
Lisinopril
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Anti-Arrhythmia Agents
Sympatholytics