CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 357 enrolled
Drug / intervention
tadalafil +1 moredrug
Likely dose
tadalafil 20 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00549302
NCT00549302Phase 3Completed
CompareCT.gov

An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients With Pulmonary Arterial Hypertension

Eli Lilly and Company·interventional·Posted Oct 25, 2007·Updated Apr 9, 2013

In Brief

A Phase 3 clinical trial evaluating tadalafil for Hypertension, Pulmonary. Completed, enrolled 357 participants across 10 sites in 10 countries.

Detailed Summary

Study to determine the long term safety of tadalafil in patients with increased blood pressure in the blood vessel that carries blood from the right heart to the lungs and to see if it will keep the disease from getting worse.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Pulmonary
CountriesBelgium, Canada, France, Germany, Ireland, Italy, Japan, Spain, United Kingdom, United States
CollaboratorsICOS Corporation

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 25, 2007
Enrollment StartDec 1, 2005
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 18.7 years ago

Interventions

tadalafildrug

20 milligram (mg) tablet, taken by mouth once a day for 52 weeks for the phase 1 portion. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of Pulmonary Arterial Hypertension (PAH).

tadalafildrug

40 mg tablet taken by mouth once a day for 52 weeks in phase 1. Open label phase includes 40 mg tablet taken by mouth once a day until the sponsor concludes the study or tadalafil becomes commercially available for the treatment of PAH.