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

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Altavant Sciences GmbH

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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/m^2, 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/m^2

• 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