drugset / Trial / NCT02503657
Safety, Tolerability, and Efficacy of MN-001 (Tipelukast) in Patients With Idiopathic Pulmonary Fibrosis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6-month open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in patients diagnosed with moderate to severe idiopathic pulmonary fibrosis (IPF). Participants were randomly assigned to receive MN-001 or matching placebo twice daily over a 26-week period. A total of 15 participants were enrolled.
Timeline
- Start
- 2016-03-09
- Primary completion
- 2020-12-07
- Completion
- 2022-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tipelukast | Small molecule | 750 mg | — |