Autopsy report · NCT00811018

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.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 5 years 9 months after it had already started.
• Ran for about 8 years 4 months before it stopped.
• 1,192 participants enrolled.
• Results were posted on the registry 9 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Pfizer

Sponsor type

Industry

Conditions

Pulmonary Arterial Hypertension

Interventions

Sitaxsentan

Participants

1,192

Sites

91

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Israel, Italy, Mexico, Netherlands and more

Trials that died the same way

• A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
  “Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.” (97% 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.” (68% 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.” (67% match in meaning)
• Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
  “The trial was terminated early on 05 October 2022 due to non-feasibility and poor recruitment and not based on safety concerns.” (67% match in meaning)
• A Study to Test the Effects of Nezavist at Different Doses in Healthy Adults
  “The trial was terminated early due to regulatory constraints preventing the continuation of study conduct.” (67% 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.