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NCT00147199 · ClinicalTrials.gov registry record · Phase 3
Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)
A Phase 3 study of Pulmonary Hypertension, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 235
- Enrollment target
- 20
- Study locations
NCT00147199: Completed Phase 3 study of Pulmonary Hypertension, sponsored by United Therapeutics.
NCT00147199 is a Phase 3 study of Pulmonary Hypertension that has completed, run by United Therapeutics. The registered enrollment target is 235 participants, below the 610-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00147199, a Phase 3 study of Pulmonary Hypertension, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 235 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.
Primary Outcome
Change in peak 6-minute walk distance from baseline to Week 12. Peak 6MWD was defined as a 6-minute walk test (6MWT) within 10 to 60 minutes after study drug inhalation
Conditions Studied
Interventions
- DRUG Inhaled treprostinil
- DRUG Placebo inhalation solution
Study Locations (20)
Other
- Medical University Graz - Graz
- Universite Libre de Bruxelles - Brussels
- University Hospital Gasthuisburg - Leuven
- Hospital Antoine Beclere - Paris
California
- UCSD Medical center - La Jolla
- UCLA Medical Center - Torrance
Alabama
- University of Alabama - Birmingham
Arizona
- University of Arizona - Tucson
Colorado
- University of Colorado - Aurora
Florida
- Orlando Heart Center - Orlando
Kansas
- Kansas University Medical Center - Kansas City
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-10 |
| Phase | Phase 3 |
What the finished NCT00147199 record still lists
NCT00147199 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 610-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Pulmonary Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Inhaled treprostinil is the first listed.
NCT00147199 names 20 study sites across 16 states, led by Other, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT00147199 about?
NCT00147199 is a clinical study titled "Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)". This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.
What is the current status of trial NCT00147199?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2005-06. Estimated completion is 2007-10.
What conditions does trial NCT00147199 study?
This clinical trial studies the following conditions: Pulmonary Hypertension.
What interventions are being tested in trial NCT00147199?
The interventions under investigation include: Inhaled treprostinil (DRUG), Placebo inhalation solution (DRUG).
Who is sponsoring clinical trial NCT00147199?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00147199 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.
Learn More About Clinical Trials
Similar trials for Pulmonary Hypertension
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 NCT00147199's enrollment target sits among peer trials
235 20th of 72 higher than 53 of 72 other Pulmonary Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Hypertension 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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