Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

Phase 2/3 Completed 12 enrolled University of North Carolina, Chapel Hill Eli Lilly and Company · collab United Therapeutics · collab University of Cincinnati · collab

NaSingle-groupOpen-labelTreatment

Summary

This study is designed to assess safety and efficacy of tadalafil in patients with Sarcoidosis Associated Pulmonary Hypertension. Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis

Timeline

Start: 2011-03
Primary completion: 2013-07
Completion: 2013-10

Outcome

Missed primary endpoint

paper The study did not meet the primary end point of change in 6MWD because of the small sample size. PMID 28090299 ↗

paper At 24 weeks, there was no overall improvement in 6-minute walk distance (6MWD). PMID 28090299 ↗

Publications

Ford HJ, Baughman RP, Aris R, Engel P, Donohue JF. Tadalafil therapy for sarcoidosis-associated pulmonary hypertension. Pulm Circ. 2016 Dec;6(4):557-562. doi: 10.1086/688775.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tadalafil	Small molecule	40 mg	—