NCT00454207

Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

A Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1)

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	sildenafil citrate (UK-92,480)	sildenafil citrate (UK-92,480)

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-03-30
• Last updated: 2021-02-21
• Results posted: 2010-09-09

Locations

8 sites across 1 country: Japan