NCT00644605

A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension

A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 275 (estimated)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of three doses of oral sildenafil (20, 40 and 80 mg three times a day \[TID\]) on exercise capacity, as measured by the 6-Minute Walk test, as well as the safety and tolerability, after 12 weeks of treatment in subjects with pulmonary arterial hypertension who are aged 18 years and over. To investigate the plasma concentration-effect relationship and to determine the population pharmacokinetic (PK) parameters.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	sildenafil	sildenafil 40 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
DRUG	sildenafil	sildenafil 80 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks; initially, patients received 40mg TID for one week and were then up-titrated to 80mg TID
DRUG	placebo	placebo by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks
DRUG	sildenafil	sildenafil 20 mg by mouth three times daily (TID), with doses at least 6 hours apart, for 12 weeks

Timeline

• Start date: 2002-10-01
• Completion: 2003-11-01
• First posted: 2008-03-27
• Last updated: 2021-02-01

Locations

68 sites across 23 countries: United States, Australia, Belgium, Brazil, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Poland, Singapore, South Africa, South Korea, Spain, Sweden, United Kingdom