Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Namita Sood, MD

Description

Summary

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

Official Title

A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension

Details

Rodatristat Ethyl is a peripherally restricted TPH inhibitor being studied as a potential treatment for PAH. This dose-ranging, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effect of Rodatristat Ethyl from baseline on pulmonary vascular resistance as measured at right heart catheterization. Patients will be enrolled into a main study with an option to enroll into an open label extension. The study is expected to enroll patients in the USA, Canada and Europe.

Keywords

Pulmonary Arterial Hypertension PAH Familial Primary Pulmonary Hypertension Hypertension Rodatristat Ethyl 300 mg tablet Rodatristat Ethyl 300 mg BID Rodatristat Ethyl 600 mg BID

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male and female 18 years or older
  • Body Mass Index (BMI) 18kg/m2 to 38kg/m2
  • Symptomatic PAH belonging to WHO Group 1 on a stable treatment regimen with one or more approved PAH treatments
  • PAH defined as mean pulmonary artery pressure ≥ 20 mmHg during right heart catheterization performed at rest
  • FEV1 ≥ 60 % of predicted normal, FEV1:FVC ratio ≥ 0.70 or TLC ≥ 70% of predicted normal
  • WHO FC II or III

You CAN'T join if...

  • Pregnant women
  • WHO Pulmonary Hypertension (PH) Group 2 - 5
  • PAH associated with significant venous or capillary involvement (PCWP > 15 mmHg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects (CHD))
  • Three or more risk factors for left ventricular disease; BMI ≥ 30 kg/m2, diagnosis of essential hypertension that is actively treated, diabetes mellitus, history of significant coronary artery disease, atrial fibrillation, and/or left atrial volume index > 41 mL/m2

  • Known genetic hypertrophic cardiomyopathy, or cardiac sarcoidosis or amyloidosis
  • The patient has a history of, or currently has, a constrictive cardiomyopathy
  • Known history of any LVEF < 40% by echocardiogram within 3 years of randomization
  • Hemodynamically significant valvular heart disease
  • Patient severely disabled and unable to complete the study
  • End stage renal disease or severe liver disease
  • Known congenital long QT syndrome (LQTS) or known family history of LQTS
  • Depression that is currently rated as severe or recent suicidal behavior or active suicidal ideation with intent to act
  • Uncontrolled arterial hypertension or hypotension
  • Patients currently taking one or more drugs known to prolong the QT interval and which are clearly associated with a known risk of Torsades de Pointe
  • QTcF interval > 450 ms for males or > 470 ms for females
  • Any ECG or clinical laboratory abnormality which precludes safe participation in the study in the opinion of the Investigator

Locations

  • UC Davis Medical Center accepting new patients
    Sacramento California 95816 United States
  • Arizona Pulmonary Specialists accepting new patients
    Phoenix Arizona 85012 United States

Lead Scientist at UC Davis

  • Namita Sood, MD
    Professor, Pulmonary, Critical Care, and Sleep Medicine. Authored (or co-authored) 11 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Altavant Sciences GmbH
Links
Sign up for this study
ID
NCT04712669
Phase
Phase 2
Study Type
Interventional
Last Updated