Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension
NCT00323297 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00323297
The ClinicalTrials.gov registry entry for NCT00323297 describes a study currently listed as completed. It is categorized as Phase 4, 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 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 27 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 Arterial Hypertension appearing as the primary indexed condition, and to 3 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: NCT00323297 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Texas, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00323297?
The interventions under investigation include: Placebo (OTHER), Bosentan (DRUG), Sildenafil Citrate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00323297?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 27 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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