Hypertrophy, Left VentricularPhase 3NCT00108082

The CLEVER Study - Coreg And Left Ventricular Mass Regression

A Phase 3 study testing carvedilol MR, atenolol and lisinopril in people with Hypertrophy, Left Ventricular, run by GlaxoSmithKline at 78 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hypertrophy, Left Ventricular
What is being tested?: carvedilol MR, atenolol and lisinopril
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 287 participants
Where: 78 sitesUnited States
Study dates: Jan 2005to Aug 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Stage 1 or Stage 2 hypertension.
Left ventricular hypertrophy.

Who cannot join

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 locations and contacts

78 sites in 1 country.

City, postcode or hospital

78 sites in 1 country

United States78 sites

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

Other trials in United States

About this study

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).

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.

Read the 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).

Conditions: Hypertrophy, Left Ventricular
Being tested: carvedilol MR, atenolol, lisinopril
Keywords: left ventricular hypertrophy (LVH), echocardiogram, left ventricular mass regression, cardiac MRI, left ventricular mass index (LVMI)hypertension
Medical subject headings: Hypertrophy, Left Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

carvedilol MRDrug
Also called Carvedilol controlled release or modified release
Study drug
atenololDrug
Comparator
lisinoprilDrug
Also called carvedilol MR, atenolol
Comparator

Study groups in NCT00108082
Study group	Role	What they receive
Carvedilol CR	Experimental	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].) Receives: Drug: carvedilol MR; Drug: lisinopril
Atenolol	Experimental	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. Receives: Drug: atenolol; Drug: lisinopril
Lisinopril	Experimental	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. Receives: Drug: lisinopril

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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].
Measured: 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
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.]
Measured: 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
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.]
Measured: 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
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.]
Measured: Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Aug 2008

First posted14 Apr 2005 (estimated)
Study startJan 2005
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hypertrophy, Left VentricularStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 287 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00108082
Sponsor's protocol ID: COR100216
Status last verified: Nov 2016
First submitted: 13 Apr 2005
Last updated: 16 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

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.
PubMed 17023232
Miller 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.
PubMed 20980215

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Heart Failure
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All Hypertrophy, Left Ventricular trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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).
ClinicalTrials.gov ID: NCT00108082
Acronym / sponsor ID: COR100216
Conditions: Hypertrophy, Left Ventricular
Keywords: left ventricular hypertrophy (LVH), echocardiogram, left ventricular mass regression, cardiac MRI, left ventricular mass index (LVMI)hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 287 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jan 2005
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 14 Apr 2005 (estimated)
Results: Posted 9 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Carvedilol CR	Experimental	Drug: carvedilol MR, Drug: lisinoprilCarvedilol 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	Experimental	Drug: atenolol, Drug: lisinoprilAtenolol 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	Experimental	Drug: lisinoprilLisinopril 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Stage 1 or Stage 2 hypertension.
Left ventricular hypertrophy.

Key exclusion criteria (6 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
carvedilol MRAlso: Carvedilol controlled release or modified releaseStudy drug	Drug	Carvedilol CR
atenololComparator	Drug	Atenolol
lisinoprilAlso: carvedilol MR, atenololComparator	Drug	Atenolol, Carvedilol CR, Lisinopril

Primary outcome

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.

13 secondary outcomes

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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
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)
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)

Results and safety

Results posted to the registry on 9 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carvedilol CR	91	53
Atenolol	100	68
Lisinopril	96	53

Primary outcome: 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). Mean (Standard Error). Unit: grams per meters squared (g/m^2)

Measure	Carvedilol CR n = 60	Atenolol n = 76	Lisinopril n = 59
Value	-6.34 (0.850)	-6.67 (0.756)	-7.94 (0.850)

Carvedilol CR vs Atenolol: Mean Difference (Final Values): 0.33 (95% CI -1.83 to 2.49), p = 0.7651, ANCOVA
Carvedilol CR vs Lisinopril: Mean Difference (Final Values): 1.60 (95% CI -0.70 to 3.90), p = 0.1711, ANCOVA

Population analysed: All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Carvedilol CR	4 of ?	54 of ?	Not reported
Atenolol	6 of ?	61 of ?	Not reported
Lisinopril	12 of ?	52 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17023232Bakris 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.
Background: PubMed 20980215Miller 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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

78 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carvedilol MR, atenolol and lisinopril in people with Hypertrophy, Left Ventricular, run by GlaxoSmithKline at 78 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00108082, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.