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NCT00323297 · ClinicalTrials.gov registry record · Phase 4
Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension
A Phase 4 study of Pulmonary Arterial Hypertension, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 4
- Development phase
- 105
- Enrollment target
- 20
- Study locations
NCT00323297: Completed Phase 4 study of Pulmonary Arterial Hypertension, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00323297 is a Phase 4 study of Pulmonary Arterial Hypertension that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 105 participants, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00323297, a Phase 4 study of Pulmonary Arterial Hypertension, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 105 participants
- Enrollment target
- 20
- Study locations
Study Summary
To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.
Primary Outcome
6MWT is the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Bosentan
- DRUG Sildenafil Citrate
Study Locations (20)
Other
- Vseobecna fakultni nemocnice v Praze - Prague
- Institut klinicke a experimentalni mediciny, Klinika kardiologie - Prague
- Clinique des Maladies Respiratoires - Lille
- Hopital Claude Huriez - Lille
- Hopital Adules Brabois - Vandœuvre-lès-Nancy
- Unfallkrankenhaus Berlin, Klinik fuer Innere Medizin - Berlin
- II. Medizinische Klinik, Kardiologie, Angiologie und Pneumologie - Coburg
- Universitaetsklinikum Essen, Zentrum fuer Innere Medizin, Klinik fuer Kardiologie - Essen
- Universitaetsklinikum Giessen und Marburg GmbH, Standort Giessen - Giessen
- Medizinische Hochschule Hannover - Hanover
- Universitaetsklinikum des Saarlandes, Innere Medizin V - Homburg
- Medizinische Klinik und Poliklinik I, Universitaetsklinikum Leipzig - Leipzig
Texas
- Baylor College of Medicine - Houston
- The Methodist Hospital - Houston
- Diagnostics Research Group - San Antonio
California
- West Los Angeles VA Healthcare, Pulmonary Hypertension Program - Los Angeles
Michigan
- Henry Ford Hospital - Detroit
Pennsylvania
- Allegheny General Hospital - Pittsburgh
New South Wales
- St. Vincents Hospital - Darlinghurst
Queensland
- The Prince Charles Hospital - Chermside
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2006-09 |
| Est. Completion | 2013-08 |
| Phase | Phase 4 |
What the finished NCT00323297 record still lists
NCT00323297 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00323297 names 20 study sites across 7 states, led by Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT00323297 about?
NCT00323297 is a clinical study titled "Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension". To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.
What is the current status of trial NCT00323297?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 105 participants. The study started on 2006-09. Estimated completion is 2013-08.
What conditions does trial NCT00323297 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT00323297?
The interventions under investigation include: Placebo (OTHER), Bosentan (DRUG), Sildenafil Citrate (DRUG).
Who is sponsoring clinical trial NCT00323297?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00323297 being conducted?
This trial has 20 study locations across California, Michigan, Pennsylvania, Texas, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Arterial 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 NCT00323297's enrollment target sits among peer trials
105 18th of 63 higher than 46 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial 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.
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