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

A Phase 2a, Randomized, Double Blind, Placebo-controlled, Parallel Group Study Investigating The Dose-response Of Pf-00489791 On Acute Hemodynamics In Subjects With Idiopathic And Familial Pulmonary Arterial Hypertension

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Pfizer decided to stop this trial early upon Stage 1 completion due to change in PF-00489791 development and not as a result of safety concerns for PF-00489791. Date of termination (LSLV) occurred on July 28, 2010.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	PF-00489791	tablet form, 1 mg, single dose (Day 1)
DRUG	PF-00489791	tablet form, 2 mg, single dose (Day 1)
DRUG	PF-00489791	tablet form, 4 mg, single dose (Day 1)
DRUG	PF-00489791	tablet form, 10 mg, single dose (Day 1)
DRUG	PF-00489791	tablet form, 20 mg, single dose (Day 1)
DRUG	placebo	tablet form, single dose (Day 1)
DRUG	sildenafil	tablet form, 20 mg, single dose (Day 1)

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-03-02
• Last updated: 2017-10-24
• Results posted: 2017-10-24

Locations

25 sites across 8 countries: United States, Canada, Germany, India, Russia, Spain, Sweden, Switzerland