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NCT00887978 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Pulmonary Hypertension, sponsored by United Therapeutics.

Completed
Registry status
Phase 3
Development phase
310
Enrollment target
20
Study locations

NCT00887978 is a Phase 3 study of Pulmonary Hypertension that has completed, run by United Therapeutics. The registered enrollment target is 310 participants, below the 609-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT00887978, a Phase 3 study of Pulmonary Hypertension, has completed, sponsored by United Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
310 participants
Enrollment target
20
Study locations

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

Pulmonary Hypertension

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

63 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, categorized as Phase 3. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 609-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (49% lower). The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.

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.

NCT00887978 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Massachusetts.

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.

What interventions are being tested in trial NCT00887978?

The interventions under investigation include: Placebo (DRUG), UT-15C SR (DRUG).

Who is sponsoring clinical trial NCT00887978?

This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.