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COMPLETED Phase 3

Study to Evaluate the Safety of Twice Daily Oral Carvedilol

NCT00129363 · View on ClinicalTrials.gov ↗

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.

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00129363

The ClinicalTrials.gov registry entry for NCT00129363 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shaddy, Robert, M.D., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00129363 reports 17 study locations spanning 13 distinct geographic areas — top geographies include California, Michigan, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00129363?

The interventions under investigation include: Carvedilol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00129363?

This trial is sponsored by Shaddy, Robert, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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