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NCT00644605 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 275
- Enrollment target
NCT00644605 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 275 participants.
The verdict
NCT00644605, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 275 participants
- Enrollment target
Study Summary
To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day \[TID\]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.
Interventions
- DRUG placebo
- DRUG sildenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2002-10 |
| Est. Completion | 2003-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00644605
The ClinicalTrials.gov registry entry for NCT00644605 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 275 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 158 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00644605 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00644605 about?
NCT00644605 is a clinical study titled "A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension". To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day \[TID\]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 year...
What is the current status of trial NCT00644605?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 275 participants. The study started on 2002-10. Estimated completion is 2003-11.
What interventions are being tested in trial NCT00644605?
The interventions under investigation include: placebo (DRUG), sildenafil (DRUG).
Who is sponsoring clinical trial NCT00644605?
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.
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