Autopsy report · NCT00795639

Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)

“Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 2 years 3 months before it stopped.
• 183 participants enrolled.
• Results were posted on the registry 1 year after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Pfizer

Sponsor type

Industry

Conditions

Pulmonary Arterial Hypertension; Pulmonary Hypertension

Interventions

Sitaxsentan; Placebo

Participants

183

Sites

85

Countries

Argentina, Bulgaria, Chile, China, Colombia, Costa Rica, Czechia, Dominican Republic, Guatemala, India, Malaysia, Mexico and more

Trials that died the same way

• A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension
  “This trial was prematurely terminated on Dec 9 2010 due to safety concerns, specifically emerging evidence of hepatic injury.” (97% match in meaning)
• Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis
  “A temporary precautionary pause in enrolment into all arms of the trial was implemented on 21 July 2026, due to emerging hepatic safety signal. A protocol amendment is currently underway.” (70% match in meaning)
• Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
  “The trial was terminated early based on an interim review by the Data and Safety Monitoring Committee for positive efficacy outcome and no safety concerns.” (67% match in meaning)
• Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP
  “The trial was stopped earlier than planned after an ad hoc interim analysis” (66% match in meaning)
• Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
  “The trial was prematurely terminated. Termination was not because of safety concerns but due to slow recruitment.” (66% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.