Conditions: Hypertension, Pulmonary
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 357
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 20 milligram (mg) tadalafil taken once a day arm 2: 40 mg tadalafil tablet taken once a day

Interventions: intervention 1: tadalafil intervention 2: tadalafil
Intervention descriptions: intervention 1: 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). intervention 2: 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.

Protocol document: