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The CLEVER Study - Coreg And Left Ventricular Mass Regression

NCT ID: NCT00108082

Last Updated: 2016-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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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

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Hypertrophy, Left Ventricular

Keywords

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left ventricular hypertrophy (LVH) echocardiogram left ventricular mass regression cardiac MRI left ventricular mass index (LVMI)hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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 \[MR\].)

Group Type EXPERIMENTAL

carvedilol MR

Intervention Type DRUG

Study drug

lisinopril

Intervention Type DRUG

Comparator

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.

Group Type EXPERIMENTAL

atenolol

Intervention Type DRUG

Comparator

lisinopril

Intervention Type DRUG

Comparator

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.

Group Type EXPERIMENTAL

lisinopril

Intervention Type DRUG

Comparator

Interventions

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carvedilol MR

Study drug

Intervention Type DRUG

atenolol

Comparator

Intervention Type DRUG

lisinopril

Comparator

Intervention Type DRUG

Other Intervention Names

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Carvedilol controlled release or modified release carvedilol MR atenolol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Chandler, Arizona, United States

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Mesa, Arizona, United States

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Peoria, Arizona, United States

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Scottsdale, Arizona, United States

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Scottsdale, Arizona, United States

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Sun City, Arizona, United States

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Fresno, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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Poway, California, United States

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Sacremento, California, United States

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San Diego, California, United States

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San Leandro, California, United States

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Santa Ana, California, United States

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Colorado Springs, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Altamonte Springs, Florida, United States

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Atlantis, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Longwood, Florida, United States

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Miami, Florida, United States

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Ormond Beach, Florida, United States

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Pembroke Pines, Florida, United States

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Evanston, Illinois, United States

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Vernon Hills, Illinois, United States

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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Pikesville, Maryland, United States

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Grand Rapids, Michigan, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Camden, New Jersey, United States

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Buffalo, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Williamsville, New York, United States

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Fayetteville, North Carolina, United States

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Greensboro, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Hillsboro, Oregon, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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West Grove, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Greer, South Carolina, United States

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Kingsport, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Danville, Virginia, United States

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Roanoke, Virginia, United States

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Springfield, Virginia, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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Argentina United States

References

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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.

Reference Type BACKGROUND
PMID: 17023232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20980215 (View on PubMed)

Study Documents

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Document Type: Dataset Specification

View Document

Document Type: Informed Consent Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Clinical Study Report

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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COR100216

Identifier Type: -

Identifier Source: org_study_id