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COMPLETED Phase 3

Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension

NCT00887978 · View on ClinicalTrials.gov ↗

Study Summary

This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG UT-15C SR

Study Locations (20)

California

  • University of California, San Francisco-Fresno — Fresno
  • UCSD Medical Center — La Jolla
  • West Los Angeles VA Healthcare Center — Los Angeles
  • UC Davis Medical Center — Sacramento
  • Harbor-UCLA Medical Center — Torrance

Florida

  • University of Florida-Jacksonville — Jacksonville
  • Cleveland Clinic Florida — Weston

Massachusetts

  • Tufts Medical Center — Boston
  • Pulmonary Critical Care Medicine, Brigham and Women's Hospital — Boston

Alabama

  • University of Alabama-Birmingham — Birmingham

Arizona

  • Arizona Pulmonary Specialist, LTD — Phoenix

Colorado

  • University of Colorado Health Science Center — Aurora

Georgia

  • Emory University School of Medicine — Atlanta

Illinois

  • University of Chicago Hospitals — Chicago

Trial Details

FieldValue
Enrollment Target 310 participants
Start Date 2009-06
Est. Completion 2011-07
Phase Phase 3

Sponsor

United Therapeutics

67 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00887978

The ClinicalTrials.gov registry entry for NCT00887978 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 310 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 67 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 Pulmonary Hypertension appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT00887978 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Massachusetts. 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 NCT00887978 about?

NCT00887978 is a clinical study titled "Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension". This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals fo...

What is the current status of trial NCT00887978?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 310 participants. The study started on 2009-06. Estimated completion is 2011-07.

What conditions does trial NCT00887978 study?

This clinical trial studies the following conditions: Pulmonary Hypertension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00887978?

The interventions under investigation include: Placebo (DRUG), UT-15C SR (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00887978?

This trial is sponsored by United Therapeutics, which has 67 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00887978 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. 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