CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 161 enrolled
Drug / intervention
carvedilol +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00052026
NCT00052026Phase 3Completed
CompareCT.gov

A Multicenter, Placebo-Controlled, 8-Month Study of the Effect of Twice Daily Carvedilol in Children With Congestive Heart Failure Due to Systemic Ventricular Systolic Dysfunction

Shaddy, Robert, M.D.·interventional·Posted Jan 23, 2003·Updated Dec 25, 2008

In Brief

A Phase 3 clinical trial evaluating carvedilol and placebo for Congestive Heart Failure. Completed, enrolled 161 participants across 21 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongestive Heart Failure
CountriesUnited States
CollaboratorsUniversity of Utah

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 23, 2003
Enrollment StartMay 1, 2000
Primary CompletionJun 1, 2005
Study CompletionJul 1, 2006
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 23.4 years ago

Interventions

carvediloldrug

low-dose carvedilol administered twice daily for 8 months

placebodrug

administered twice daily for 8 months

carvediloldrug

high-dose carvedilol administered twice daily for 8 months