Clinical Trial: PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.
Detailed Summary: This is a randomized, double-blind, placebo-controlled, multicenter study. The key measure of effectiveness of the study drug will be determined using a 6-minute walk test. Eligible patients will be treated for 16 weeks and may be eligible to enter a 52-week extension phase study (PHIRST-2). Study procedures for both studies (PHIRST-1 and PHIRST-2) will include routine blood tests, medical history, physical exams, questionnaire responses, and exercise tests.
Sponsor: Eli Lilly and Company
Current Primary Outcome: 6 minute walk distance change from baseline to Week 16 [ Time Frame: 16 weeks ]
Original Primary Outcome: 6 minute walk distance change from baseline to Week 16
Current Secondary Outcome:
- World Health Organization (WHO) functional class, Borg dyspnea, cardiopulmonary hemodynamics, quality of life - change from baseline to Week 16 [ Time Frame: 16 weeks ]
- Time to first occurrence of clinical worsening [ Time Frame: Not defined ]
Original Secondary Outcome: WHO functional class, Borg dyspnea, cardiopulmonary hemodynamics, quality of life - Change from baseline to Week 16. Time to first occurence of clinical worsening.
Information By: Eli Lilly and Company
Dates:
Date Received: August 1, 2005
Date Started: August 2005
Date Completion:
Last Updated: February 13, 2008
Last Verified: February 2008
