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NCT00129363 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate the Safety of Twice Daily Oral Carvedilol

A Phase 3 study of Congestive Heart Failure, sponsored by Shaddy, Robert, M.D..

Completed
Registry status
Phase 3
Development phase
75
Enrollment target
17
Study locations

NCT00129363: Completed Phase 3 study of Congestive Heart Failure, sponsored by Shaddy, Robert, M.D..

NCT00129363 is a Phase 3 study of Congestive Heart Failure that has completed, run by Shaddy, Robert, M.D.. The registered enrollment target is 75 participants, below the 329-participant average among 51 other Congestive Heart Failure trials with a reported enrollment target (77% lower). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00129363, a Phase 3 study of Congestive Heart Failure, has completed, sponsored by Shaddy, Robert, M.D..

COMPLETED
Registry status
Phase 3
Development phase
75 participants
Enrollment target
17
Study locations

Study Summary

The objective of this study is to evaluate the long-term safety of carvedilol in pediatric patients with chronic heart failure, who completed the Pediatric Carvedilol Study 321. Carvedilol will be provided as open-label therapy for a period of at least 6 months (or until termination of the study) by SmithKline Beecham Corporation d/b/a GlaxoSmithKline (GSK) or the University Sponsor.

Conditions Studied

Interventions

  • DRUG Carvedilol

Study Locations (17)

California

  • Mattel Children's Hospital at UCLA - Los Angeles
  • Children's Hospital Los Angeles - Los Angeles
  • Stanford University - Palo Alto

Michigan

  • C.S. Mott Children's Hospital - Ann Arbor
  • Children's Hospital of Michigan - Detroit

Texas

  • UT Southwestern Medical Center - Dallas
  • Texas Children's Hospital - Houston

Colorado

  • University of Colorado - Denver

Florida

  • University of Miami - Miami

Illinois

  • Children's Memorial Hospital - Chicago

Massachusetts

  • Children's Hospital, Boston - Boston

Missouri

  • Washington University - St Louis

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2002-01
Est. Completion 2006-01
Phase Phase 3
Shaddy, Robert, M.D.

2 total trials

What the finished NCT00129363 record still lists

NCT00129363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 329-participant average among 51 other Congestive Heart Failure trials with a reported enrollment target (77% lower).

The record links to 1 condition, with Congestive Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Carvedilol is the first listed.

NCT00129363 lists 17 locations in 13 states (California, Michigan, Texas).

Frequently Asked Questions

What is clinical trial NCT00129363 about?

NCT00129363 is a clinical study titled "Study to Evaluate the Safety of Twice Daily Oral Carvedilol". The objective of this study is to evaluate the long-term safety of carvedilol in pediatric patients with chronic heart failure, who completed the Pediatric Carvedilol Study 321. Carvedilol will be provided as open-label therapy for a period of at least 6 months (or until termination of the study) by...

What is the current status of trial NCT00129363?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2002-01. Estimated completion is 2006-01.

What conditions does trial NCT00129363 study?

This clinical trial studies the following conditions: Congestive Heart Failure.

What interventions are being tested in trial NCT00129363?

The interventions under investigation include: Carvedilol (DRUG).

Who is sponsoring clinical trial NCT00129363?

This trial is sponsored by Shaddy, Robert, M.D., which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00129363 being conducted?

This trial has 17 study locations across California, Colorado, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Congestive Heart Failure

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00129363's enrollment target sits among peer trials

75 31st of 51 higher than 21 of 51 other Congestive Heart Failure trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Congestive Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00129363, the US trial registry maintained by the National Library of Medicine. NCT00129363 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.