drugset / Trial / NCT00853112

A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension

NCT00853112 ↗

Phase 2 Terminated 48 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

Summary

Study will assess PF-00489791 efficacy and safety in Pulmonary Arterial Hypertension (PAH)

Timeline

Start
2009-04
Primary completion
2010-07
Completion
2010-07

Outcome

Missed primary endpoint

Stopped: “See termination reason in detailed description.”

registry analysis (superiority or other test); Placebo vs PF-00489791 1 mg; p = 0.120; Predicted Mean Difference -115.0 (95% CI -371.5 to -1.1); Bayesian 4-parameter Emax model NCT00853112 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject PF-00489791 Small molecule 1 mg Oral
Subject PF-00489791 Small molecule 2 mg Oral
Subject PF-00489791 Small molecule 4 mg Oral
Subject PF-00489791 Small molecule 10 mg Oral
Subject PF-00489791 Small molecule 20 mg Oral
Comparator Sildenafil Unknown 20 mg —