Rodatristat Ethyl 300 mg tablet for Pulmonary Arterial Hypertension

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pulmonary Arterial Hypertension+6 MoreRodatristat Ethyl 300 mg tablet - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new drug to see if it's safe and effective in treating pulmonary arterial hypertension.

Eligible Conditions
  • Pulmonary Arterial Hypertension

Treatment Effectiveness

Study Objectives

2 Primary · 16 Secondary · Reporting Duration: From initiation to Week 24

Week 24
Change from baseline in 6MWD
Change from baseline in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) levels
Percent change from baseline of pulmonary vascular resistance (PVR) as measured by right heart catheterization between active and placebo
Proportion of patients who improve in WHO World Health Organization (WHO) Functional Class (FC)
Week 24
Change from baseline in of right atrial size by echocardiogram
Body Weight Changes
Change from baseline in the RV fractional area change by echocardiogram
Change from baseline in the tricuspid annular plane systolic excursion (TAPSE) by echocardiogram
Change from baseline in the tricuspid annular systolic velocity by echocardiogram
Change from baseline of cardiac index (CI)
Change from baseline of mean mixed venous oxygen saturation (SvO2)
Change from baseline of mean pulmonary artery pressure (mPAP)
Change from baseline of pulmonary artery compliance (PAC)
Change from baseline of pulmonary vascular resistance as measured by right heart catheterization
Change from baseline on the following actigraphy endpoints
Change in baseline in WHO FC World Health Organization (WHO) Functional Class (FC)
Change in baseline in the Pulmonary Arterial Hypertension Symptoms and Impact Questionnaire (PAH SYMPACT) Score
Change in baseline in the Registry to Evaluate Early and Long Term PAH Disease Management (REVEAL) Lite 2 score
Time to Clinical Improvement (TTCI)
Time to the first occurrence of a clinical worsening event (TTCW)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Rodatristat Ethyl 300 mg BID
1 of 3
Rodatristat Ethyl 600 mg BID
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

90 Total Participants · 3 Treatment Groups

Primary Treatment: Rodatristat Ethyl 300 mg tablet · Has Placebo Group · Phase 2

Rodatristat Ethyl 300 mg BIDExperimental Group · 3 Interventions: Rodatristat Ethyl 300 mg tablet, rodatristat ethyl 300 mg tablet BID, Placebo · Intervention Types: Drug, Drug, Drug
Rodatristat Ethyl 600 mg BIDExperimental Group · 2 Interventions: Rodatristat Ethyl 300 mg tablet, rodatristat ethyl 600 mg BID · Intervention Types: Drug, Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from initiation to week 24

Who is running the clinical trial?

Altavant Sciences GmbHLead Sponsor
4 Previous Clinical Trials
89 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
3 Patients Enrolled for Pulmonary Arterial Hypertension
Howard M Lazarus, MD, FCCPStudy DirectorAltavant Sciences GmbH

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not had a hospitalization due to HIV for at least 4 weeks prior to Screening.
PVR ≥ 350 dyne/sec/cm5.