ELEVATE 2
Research type
Research Study
Full title
A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension
IRAS ID
1003552
Contact name
Watiri Kamau-Kelley
Contact email
Sponsor organisation
Altavant Sciences GmbH
Eudract number
2020-004971-42
Clinicaltrials.gov Identifier
Research summary
This research study is testing the investigational drug rodatristat ethyl for the treatment of a serious rare disease called pulmonary arterial hypertension (PAH). In patients with PAH, the blood vessels in the lungs are diseased and become thick and narrow, causing an increase in the blood pressure between the heart and lungs. Currently PAH is incurable, however treatments are available to help alleviate the symptoms. The current standard treatment includes the use of medications called vasodilators, which act to open the blood vessels in the lungs, to improve blood flow and reduce high blood pressure in the blood vessels of the lungs.
Rodatristat ethyl is being tested to understand if it may be a useful additional treatment when given to patients who are already taking vasodilators for their PAH symptoms. Prior to this study, rodatristat ethyl has been given to a few patients with PAH. It has also been previously given to 136 healthy people in clinical trials to help the researchers understand how it acts in the body and to identify any severe side effects that would make it unfit for testing in clinical trials. There were no severe side effects in healthy people who took rodatristat ethyl, therefore the Sponsor is studying it in more detail in this next stage of clinical trials.
The purpose of this research study is to:
• identify if rodatristat ethyl can improve PAH symptoms
• better understand the safety and tolerability of rodatristat ethyl
• study how rodatristat ethyl is processed in the body
• better understand how rodatristat ethyl impacts the levels of a substance called serotonin in the body of PAH patients.It is expected that approximately 90 patients with PAH will participate in this study at about 45-50 study sites across US, Canada and Europe.
REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0333
Date of REC Opinion
7 Jul 2021
REC opinion
Further Information Favourable Opinion