NCT04712669

A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE)

A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Altavant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.

Detailed description

Rodatristat Ethyl is a peripherally restricted TPH inhibitor being studied as a potential treatment for PAH. This dose-ranging, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effect of Rodatristat Ethyl from baseline on pulmonary vascular resistance as measured at right heart catheterization. Patients will be enrolled into a main study with an option to enroll into an open label extension. The study is expected to enroll patients in the USA, Canada and Europe.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	rodatristat ethyl 300 mg tablet BID	rodatristat ethyl 300 mg tablet + matching placebo tablet twice daily on top of standard of care
DRUG	rodatristat ethyl 600 mg BID	2 rodatristat ethyl 300 mg tablets twice daily on top of standard of care
DRUG	Placebo	2 matching placebo tablets on top of standard of care

Timeline

• Start date: 2021-03-15
• Primary completion: 2023-06-05
• Completion: 2023-08-28
• First posted: 2021-01-15
• Last updated: 2025-06-04
• Results posted: 2025-06-04

Locations

64 sites across 17 countries: United States, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Czechia, France, Germany, Italy, Latvia, Moldova, Poland, Serbia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study