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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 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.

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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

Sponsor

Shaddy, Robert, M.D.

2 total trials

What the Registry Record Tells You About NCT00129363

The ClinicalTrials.gov registry entry for NCT00129363 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 329-participant average among 51 other Congestive Heart Failure trials with a reported enrollment target (77% lower). The listed sponsor is Shaddy, Robert, M.D., which has 2 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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