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NCT00325442 · ClinicalTrials.gov registry record · Phase 3
FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
A Phase 3 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 354
- Enrollment target
NCT00325442 is a Phase 3 study that has completed, run by United Therapeutics. The registered enrollment target is 354 participants.
The verdict
NCT00325442, a Phase 3 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 354 participants
- Enrollment target
Study Summary
This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16. Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
Interventions
- DRUG Placebo
- DRUG Oral treprostinil (UT-15C) sustained release tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2006-10 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00325442
The ClinicalTrials.gov registry entry for NCT00325442 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 354 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00325442 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00325442 about?
NCT00325442 is a clinical study titled "FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)". This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals fo...
What is the current status of trial NCT00325442?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 354 participants. The study started on 2006-10. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00325442?
The interventions under investigation include: Placebo (DRUG), Oral treprostinil (UT-15C) sustained release tablets (DRUG).
Who is sponsoring clinical trial NCT00325442?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
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