A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)
Recruiting in Palo Alto (17 mi)
+64 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Altavant Sciences GmbH
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.
Research Team
HM
Howard M Lazarus, MD, FCCP
Principal Investigator
Altavant Sciences GmbH
Eligibility Criteria
Inclusion Criteria
PVR ≥ 350 dyne•sec/cm5
Congenital systemic to pulmonary shunt (atrial septal defect, ventricular septal defect, patent ductus arteriosus) repaired at least one year prior to Screening
stable treatment with HIV medications for at least 8 weeks prior to Screening
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Treatment Details
Interventions
- Rodatristat Ethyl (Serotonin Synthesis Inhibitor)
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Rodatristat Ethyl 600 mg BIDExperimental Treatment1 Intervention
Rodatristat ethyl 600 mg tablet BID + standard of care medication(s) taken for 24 weeks
Group II: Rodatristat Ethyl 300 mg BIDExperimental Treatment2 Interventions
Rodatristat ethyl 300 mg tablet BID + standard of care medication(s) taken for 24 weeks
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo tablet + standard of care medication(s) taken for 24 weeks
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Who Is Running the Clinical Trial?
Altavant Sciences GmbH
Lead Sponsor
Trials
6
Recruited
220+