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A Study to Compare the Effects of Coreg CR and Coreg IR on Heart Function in Subjects With Stable Chronic Heart Failure

NCT00323037 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2023-03-28

Study results available
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Summary

The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in improving heart function in subjects with stable chronic heart failure.

Conditions

  • Congestive Heart Failure

Interventions

DRUG

carvedilol controlled release

Carvedilol controlled release (10, 20, 40 or 80 mg) and placebo taken in the morning. Two placebos taken in the evening. A total of 4 pills will be taken PO daily.

DRUG

carvedilol immediate release

Carvedilol immediate release (3.125, 6.25, 12.5 or 25 mg) and placebo, taken PO, twice-daily.

Sponsors & Collaborators

  • CTI Clinical Trial and Consulting Services

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • CTI-1, LLC

    lead INDUSTRY

Principal Investigators

  • Barry Greenberg, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-04-30
Completion
2008-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00323037 on ClinicalTrials.gov