A Phase 3 interventional study of tadalafil and tadalafil in Pulmonary Hypertension, sponsored by Eli Lilly and Company. Completed at 6 sites in 3 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2008-02-21.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 406 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo
Drug: placebo
2.5 mg tadalafil
Drug: tadalafil
10 mg tadalafil
Drug: tadalafil
20 mg tadalafil
Drug: tadalafil
40 mg tadalafil
Drug: tadalafil
tadalafil 2.5 mg and placebo tablets taken by mouth once a day for 16 weeks.
Also known as: LY450190, Cialis, IC351
tadalafil 10 mg and placebo tablets taken by mouth once a day for 16 weeks.
Also known as: LY450190, Cialis, IC351
tadalafil 20 mg and placebo tablets taken by mouth once a day for 16 weeks.
Also known as: LY450190, Cialis, IC351
tadalafil 40 mg and placebo tablets taken by mouth once a day for 16 weeks.
Also known as: LY450190, Cialis, IC351
placebo tablet taken by mouth once a day for 16 weeks
6 minute walk distance change from baseline to Week 16
Time frame: 16 weeks
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
This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company