Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00796666 · ClinicalTrials.gov registry record · Phase 3
Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
NCT00796666: Clinical Trial Phase 3 study, sponsored by Pfizer.
NCT00796666 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 131 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00796666, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
Study Summary
As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.
Primary Outcome
Clinical worsening defined as time between first dose of study drug and occurrence of death; or heart-lung/lung transplant; or hospitalization for worsening pulmonary atrial hypertension (PAH); or atrial septostomy; or withdrawal due to addition of chronic medications for treatment of worsening PAH: prostacyclin/prostacyclin analogues/phosphodiesterase-5inhibitors/alternative endothelin receptor antagonists/intravenous inotropes; or increase of calcium channel blockers or oxygen. TTCW measured a
Interventions
- DRUG Sitaxsentan
- DRUG Sitaxsentan and Sildenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
Why NCT00796666 stopped before completion
NCT00796666 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Sitaxsentan is the first listed.
NCT00796666 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00796666 about?
NCT00796666 is a clinical study titled "Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil". As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.
What is the current status of trial NCT00796666?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2009-05. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00796666?
The interventions under investigation include: Sitaxsentan (DRUG), Sitaxsentan and Sildenafil (DRUG).
Who is sponsoring clinical trial NCT00796666?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00796666's enrollment target sits among peer trials
131 1593rd of 2000 higher than 407 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03051464 · 131 participants · Phase 2
No Surgery Trial / Two Dose-escalation Strategies
- NCT04301843 · 131 participants · Phase 2
Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma
- NCT04748549 · 131 participants · NA
Intraoperative VR for Older Patients Undergoing TKA
- NCT05951179 · 131 participants · Phase 2
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia