← Back to Search

Serotonin Synthesis Inhibitor

Rodatristat Ethyl 300 mg BID for Pulmonary Arterial Hypertension

Phase 2

Waitlist Available

Research Sponsored by Altavant Sciences GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from initiation to week 24

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from initiation to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from initiation to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change from baseline of pulmonary vascular resistance (PVR) as measured by right heart catheterization between active and placebo

Secondary outcome measures

Change from baseline in 6MWD

Change from baseline in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) levels

Proportion of patients who improve in WHO World Health Organization (WHO) Functional Class (FC)

Other outcome measures

Change from baseline on the following actigraphy endpoints

Time to Clinical Improvement (TTCI)

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rodatristat ethyl 300 mg tablet BID

2021

Completed Phase 2

~110

rodatristat ethyl 600 mg BID

2021

Completed Phase 2

~110

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Altavant Sciences GmbHLead Sponsor

5 Previous Clinical Trials

116 Total Patients Enrolled

1 Trials studying Pulmonary Arterial Hypertension

3 Patients Enrolled for Pulmonary Arterial Hypertension

Howard M Lazarus, MD, FCCPStudy DirectorAltavant Sciences GmbH

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment welcoming new participants?

"Affirmative. Clinicaltrials.gov hosts data that confirms this clinical trial is actively recruiting participants, having been first uploaded on March 15th 2021 and last updated on July 11th 2022. The research requires 90 patients to be enrolled from 30 different sites."

Answered by AI

How far-reaching is this experiment's reach?

"Presently, this clinical trial is running in 30 different sites across the USA. Participants can select their nearest location from places such as Los Angeles, Washington and Jacksonville to reduce travel requirements upon enrollment."

Answered by AI

How many participants are being enrolled to participate in this research?

"Indeed, clinicialtrials.gov affirms that this trial is currently recruiting participants; it was first published on March 15th 2021 and the most recent update occurred July 11th 2022. 90 patients must be recruited from 30 sites to complete the study."

Answered by AI

Is Rodatristat Ethyl 300 mg tablet a hazard for participants?

"The safety of Rodatristat Ethyl 300 mg tablet has been evaluated as a 2, taking into account that this is still a Phase 2 trial. While there are some reports on the drug's safety, none have yet determined its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)

2021. "A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04712669.