A Randomized, Double-Blind, Placebo-controlled, Safety and Efficacy Study of VI-0106 (Extended-release Tacrolimus) in Subjects with PAH and Functional Limitations Despite Optimized Therapy with Available PAH Medications

Condition studied

Pulmonary Arterial Hypertension (PAH)

Investigational medicinal product(s)

Every trial of Tacrolimus across our registers →

Eligibility

Primary endpoint

Change from baseline in 6MWD at Week 24.

Endpoint detail

Percentage of subjects with a ≥1 category improvement vs baseline in WHO functional class at Week 24, Time to clinical worsening: first occurrence of: all-cause death; inpatient hospitalization for PAH or right-sided HF; worsening-related listing for lung or heart-lung transplant; diminished functional capacity: 6MWD ↓ ≥15% and ≥22 m (confirmed ×2, ≥4 h apart) AND WHO FC ↑ ≥1 category (FC IV at baseline: 6MWD criterion alone sufficient); initiation of rescue PAH therapy or IV prostacyclin dose ↑ ≥10%, Time to clinical worsening by a restricted definition comprised of all-cause death and in-patient hospitalization for PAH or right-sided heart failure, Change from baseline in 6MWD at Week 28 (4 weeks after temporary withdrawal of VI-0106) as measurement of a disease-modifying effect.