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Safety and Efficacy Study of Carvedilol to Treat Children With Congestive Heart Failure

NCT00052026 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2008-12-25

No results posted yet for this study

Summary

The purpose of this study is to determine whether a new medicine, called carvedilol, improves symptoms and heart function in children who have congestive heart failure (diminished function of their heart muscle that pumps blood to the body). To accomplish this, we will give carvedilol to some patients who have diminished heart function and congestive heart failure and see whether symptoms and heart function are better at the end of an 8 month period in those who received carvedilol compared to the other patients who did not receive carvedilol. We will be testing 2 different doses of carvedilol compared to no additional medicine.

Conditions

  • Congestive Heart Failure

Interventions

DRUG

carvedilol

low-dose carvedilol administered twice daily for 8 months

DRUG

placebo

administered twice daily for 8 months

DRUG

carvedilol

high-dose carvedilol administered twice daily for 8 months

Sponsors & Collaborators

Principal Investigators

  • Robert E. Shaddy, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-05-31
Primary Completion
2005-06-30
Completion
2006-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00052026 on ClinicalTrials.gov