NCT00549302

Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	tadalafil	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).
DRUG	tadalafil	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.

Timeline

• Start date: 2005-12-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2007-10-25
• Last updated: 2013-04-09
• Results posted: 2013-02-18

Locations

10 sites across 10 countries: United States, Belgium, Canada, France, Germany, Ireland, Italy, Japan, Spain, United Kingdom