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

NCT04712669 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-06-04

Study results available
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Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Altavant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Howard M Lazarus, MD, FCCP · Altavant Sciences GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2023-06-05
Completion
2023-08-28
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Latvia
  • Moldova
  • Poland
  • Serbia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04712669 on ClinicalTrials.gov