Autopsy report · NCT00430716

To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

“This study was terminated at the recommendation of an independent Data Monitoring Committee. The decision was not based on any safety concerns.”

The sponsor’s own words in the registry.

Life of this trial

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

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Sponsor type

Industry

Conditions

Pulmonary Arterial Hypertension

Interventions

Sildenafil citrate; Sildenafil citrate; Sildenafil citrate; Sildenafil citrate

Participants

130

Sites

46

Countries

Belgium, Brazil, Bulgaria, China, Greece, India, Italy, Latvia, Malaysia, Netherlands, Philippines, Poland and more

Trials that died the same way

• GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
  “The study was terminated following assessment of the lack of efficacy of the study product by the Independent Data monitoring Committee for the study.” (78% match in meaning)
• A Study of Ponsegromab in People With Heart Failure
  “Following a prespecified interim analysis, and in consultation with the independent Data Monitoring Committee, the Sponsor terminated the study” (74% match in meaning)
• Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy
  “This study was terminated based on preliminary safety data.” (73% match in meaning)
• Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease
  “Due to a safety signal found at a planned interim safety review, further conduct of this safety study is not recommended hence the study was terminated.” (71% match in meaning)
• Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)
  “Study terminated based on evaluation of safety data.” (71% 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.