A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (ELEVATE 2)
Study Purpose
The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Inclusion Criteria:
1. Male and female 18 years or older 2. Body Mass Index (BMI) >18kg/m2 to <=40kg/m2 3. Symptomatic PAH belonging to one of the following 2018 WHO Clinical Group 1 subtypes: a. Idiopathic PAH b. Heritable PAH c. Drug- or toxin-induced d. PAH associated with: 1. Connective tissue disease. 2. Congenital systemic to pulmonary shunt (atrial septal defect, ventricular septal defect, patent ductus arteriosus) repaired at least one year prior to Screening. 3. Human immunodeficiency virus (HIV) infection- - if diagnosed with HIV, must have stable disease status defined as follows: 1.
- III. 5.
Exclusion Criteria:
1. Women of childbearing potential who are pregnant, planning to become pregnant, or lactating or female/male patients unwilling to use effective contraception. 2. WHO pulmonary hypertension (PH) Group 1 PAH associated with portal hypertension or schistosomiasis; PH due to left heart disease (WHO PH Group 2), lung diseases and/or hypoxia (WHO PH Group 3), chronic thromboembolic PH (WHO PH Group 4), or PH with unclear multifactorial mechanisms (WHO PH Group 5) 3. PH associated with significant venous or capillary involvement (PCWP > 15 mmHg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects (CHD) 4. Three or more of the following risk factors for left ventricular disease: 1. BMI > 30 kg/m2. 2. Diagnosis of essential hypertension that is actively treated. 3. Diabetes mellitus. 4. History of significant coronary artery disease (e.g., chronic stable angina, history of coronary intervention within the last 3 months, or a stenosis > 70% at coronary angiography) 5. Atrial fibrillation. 6. Left atrial volume index > 41 mL/m2 [or left atrial diameter (LA) > 4 cm if LAVi unavailable] 5. Known genetic hypertrophic cardiomyopathy. 6. Known cardiac sarcoidosis or amyloidosis. 7. The patient has a history of, or currently has, a constrictive cardiomyopathy. 8. Known history of any left ventricular ejection fraction (LVEF) < 40% by echocardiogram within 3 years of randomization (Note: a transient decline in LVEF below 40% that occurred and recovered more than 6 months before the start of Screening and was associated with an acute intercurrent condition [e.g., atrial fibrillation] is allowed). 9. Hemodynamically significant valvular heart disease as determined by the Investigator, including: 1. greater than mild aortic and/or mitral stenosis and/or. 2. severe mitral and/or aortic regurgitation (> Grade 3) 10. Severe arthritis, musculoskeletal problems, or morbid obesity that, in the opinion of the Investigator, is the cause of the patient's functional limitation and would affect the patient's ability to perform or complete the 6MWT.Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04712669 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Altavant Sciences GmbH |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Howard M Lazarus, MD, FCCP |
Principal Investigator Affiliation | Altavant Sciences GmbH |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Czechia, France, Germany, Italy, Latvia, Moldova, Republic of, Poland, Serbia, Spain, Ukraine, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Pulmonary Arterial Hypertension |
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.
Arms
Experimental: Rodatristat Ethyl 300 mg BID
Rodatristat ethyl 300 mg tablet BID + standard of care medication(s) taken for 24 weeks
Experimental: Rodatristat Ethyl 600 mg BID
Rodatristat ethyl 600 mg tablet BID + standard of care medication(s) taken for 24 weeks
Placebo Comparator: Placebo
Matching placebo tablet + standard of care medication(s) taken for 24 weeks
Interventions
Drug: - rodatristat ethyl 300 mg tablet BID
rodatristat ethyl 300 mg tablet + matching placebo tablet twice daily on top of standard of care
Drug: - rodatristat ethyl 600 mg BID
2 rodatristat ethyl 300 mg tablets twice daily on top of standard of care
Drug: - Placebo
2 matching placebo tablets on top of standard of care
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Arizona Pulmonary Specialists
Phoenix, Arizona, 85012
Status
Recruiting
Address
University of California San Diego Health Sciences
La Jolla, California, 92093
Status
Recruiting
Address
VA Greater LA Healthcare System/UCLA
Los Angeles, California, 90073
Status
Not yet recruiting
Address
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Status
Recruiting
Address
UC Davis Medical Center
Sacramento, California, 95816
Status
Recruiting
Address
Jeffrey S. Sager, MD Medical Corporation
Santa Barbara, California, 93105
Status
Recruiting
Address
University of Colorado
Aurora, Colorado, 80045
Status
Recruiting
Address
George Washington University Medical Center
Washington, District of Columbia, 20037
Status
Recruiting
Address
Mayo Clinic Florida
Jacksonville, Florida, 32224
Status
Recruiting
Address
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Recruiting
Address
Norton Pulmonary Specialists
Louisville, Kentucky, 40202
Status
Recruiting
Address
Tufts Medical Center
Boston, Massachusetts, 02111
Status
Recruiting
Address
Brigham and Women's Hospital (BWH), Harvard Medical School
Boston, Massachusetts, 02115
Status
Recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Mayo Clinic
Rochester, Minnesota, 55905
Status
Recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
University of New Mexico Heath Science Center
Albuquerque, New Mexico, 87106
Status
Recruiting
Address
NYU Langone Health
New York, New York, 10016
Status
Recruiting
Address
University of Rochester
Rochester, New York, 14623
Status
Recruiting
Address
University of North Carolina Medical Center - Chapel Hill
Chapel Hill, North Carolina, 27514
Status
Recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Recruiting
Address
University of Cincinnati Physicians
Cincinnati, Ohio, 45219
Status
Recruiting
Address
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Status
Recruiting
Address
Brown University - Rhode Island Hospital
Providence, Rhode Island, 02903
Status
Recruiting
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Status
Recruiting
Address
UT Southwestern
Dallas, Texas, 75390
Status
Recruiting
Address
Houston Methodist Hospital
Houston, Texas, 77030
Status
Recruiting
Address
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3307
International Sites
Status
Recruiting
Address
Ordensklinikum Linz GmbH Elisabethinen
Linz, Oberösterreich, 4020
Status
Recruiting
Address
AKH- Wien, Medizinische Univsersität Wien
Wien, , 1090
Status
Recruiting
Address
Hôpital Erasme
Brussels, Brussels Capital Region, 1070
Status
Recruiting
Address
UZ Leuven - Campus Gasthuisberg - Pneumologie
Leuven, Vlaams Brabant, 3000
Status
Recruiting
Address
University Clinical Centre of the Republic of Srpska
Banja Luka, , 78 000
Status
Recruiting
Address
University Clinical Hospital Mostar
Mostar, , 88000
Status
Recruiting
Address
University MHAT "Sv. Anna"
Sofia, Sofia-Grad, 1750
Status
Recruiting
Address
Peter Lougheed Centre
Calgary, Alberta, T1Y6J4
Status
Recruiting
Address
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9
Status
Recruiting
Address
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2N2
Status
Recruiting
Address
Sir Mortimer B. Davis Jewish General Hospital
Montréal, Quebec, H3T 1E2
Status
Recruiting
Address
Fakultni nemocnice Olomouc
Olomouc, , 779 00
Status
Recruiting
Address
Vseobecna fakultni nemocnice v Praze
Praha 2, , 128 08
Status
Recruiting
Address
Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
Caen Cedex, Calvados, 14033
Status
Recruiting
Address
Groupement Hospitalier Est
Lyon, Rhône, 69677
Status
Recruiting
Address
Chu De Bicetre
Le Kremlin-Bicêtre, Val-de-Marne, 94275
Status
Recruiting
Address
CHU de Saint-Etienne - Hopital Nord
Saint-Étienne, , 42270
Status
Recruiting
Address
Universitätsklinikum Giessen und Marburg
Gießen, , 35392
Status
Recruiting
Address
Umberto I Policlinico di Roma, Università La Sapienza
Rome, Roma, 00161
Status
Recruiting
Address
AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can
Genova, , 16132
Status
Recruiting
Address
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia, , 27100
Status
Recruiting
Address
P.Stradina Clinical University Hospital
Riga, , LV-1002
Status
Recruiting
Address
Spitalul Clinic Republican
Chisinau, , MD2025
Status
Recruiting
Address
Wojewodzki Specjalistyczny Szpital im. dr Wl. Bieganskiego
Łódź, Lódzkie, 91-347
Status
Recruiting
Address
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , 15-276
Status
Recruiting
Address
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, , 20-954
Status
Active, not recruiting
Address
Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina
Otwock, , 05-400
Status
Recruiting
Address
Institute for Cardiovascular diseases of Vojvodina
Sremska Kamenica, Vojvodina, 21204
Status
Recruiting
Address
Institute for Pulmonary Diseases of Vojvodina
Sremska Kamenica, Vojvodina, 21204
Status
Recruiting
Address
Clinical Center of Serbia
Belgrade, , 11000
Status
Recruiting
Address
Hospital Clinic de Barcelona
Barcelona, , 08036
Status
Recruiting
Address
Hospital Universitario 12 de Octubre
Madrid, , 28041
Status
Active, not recruiting
Address
Dnipropetrovsk Regional Clinical Diagnostic Center
Dnipropetrovs'k, Dnipropetrovs'ka Oblast', 49070
Status
Active, not recruiting
Address
Nats Naukovyi Tsentr Amn Ukrainy
Kyiv, , 03680
Status
Recruiting
Address
Royal Free London NHS Foundation Trust
London, , NW3 2QG
Status
Recruiting
Address
Royal Brompton Hospital
London, , SW3 6NP