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Long Term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension

Study Purpose

This study is an open-label extension study to determine the long-term safety and tolerability of APD811 in patients with WHO Group 1 PAH who have completed the Phase 2 study, APD811-003. Patients must have completed the APD811-003 study and must meet eligibility criteria for APD811-007.

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 - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Evidence of a personally signed and dated informed consent document.
  • - Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and is deemed an appropriate candidate for participation in a long-term extension study and administration of APD811.
  • - Fulfilled all eligibility criteria for APD811-003 and completed the study as planned.
  • - Patients who discontinued for clinical worsening in APD811-003 and were assigned to placebo and completed all end of study procedures including right heart catheterization (RHC) may participate after their data from the APD811-003 study is cleaned and locked.

Exclusion Criteria:

  • - Patients who enrolled in APD811-003 and were withdrawn from study drug treatment due to any AE, SAE, or clinical worsening if assigned to APD811, or patients who did not complete the APD811 003 study for other reasons.
  • - Female patients who wish to become pregnant.
  • - Systolic BP <90 mmHg at Baseline/Day 1.
- Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study

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.

 NCT02279745
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.

 United Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Active, not recruiting
Countries Australia, Bulgaria, Czechia, Hungary, Poland, Romania, Serbia, Slovakia, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Pulmonary Arterial Hypertension
Additional Details

This study is an open-label extension study to determine the long-term safety and tolerability of APD811 in patients with WHO Group 1 PAH who have completed the Phase 2 Study APD811-003. Patients must have completed Study APD811-003 and met eligibility criteria for Study APD811-007. Additionally, placebo-treated patients who discontinue study drug treatment due to clinical worsening in Study APD811-003 will be permitted to enroll in Study APD811-007, upon approval of the medical monitor, provided that all end of study procedures including right heart catheterization are performed per protocol. The Week 25 Visit in Study APD811-003 will serve as the Baseline Visit for Study APD811-007. All patients enrolled in Study APD811-007 will receive open-label treatment with APD811. The starting dose and titration schedule will be individually determined and in accordance with the starting dose and titration schedule optimized from Study APD811-003. Adjustments in the dose and titration schedule may be made according to patient tolerability. After an individual patient completes Study APD811-003 and that patient's database is locked, patient unblinding will occur. Patients on active treatment (APD811) will remain on current dose and have onsite clinical assessments performed every 3 months until the patient is discontinued from the study. Patients in the placebo treatment group will undergo a dose titration period until a stable, maximum tolerated dose (MTD) is reached (up to 9 weeks), followed by a treatment period after the MTD is determined during which monthly onsite clinic assessments will be performed for the first 3 months and then every 3 months until the patient is discontinued from the study or the study is terminated (see Table 2). Discontinuation of the study may also occur at Sponsor's decision to terminate the study. Dose reductions may be made at any time for safety reasons. Incremental dose increases will also be allowed during the Treatment Period at the discretion of the investigator (as clinically indicated) and according to the stepwise titration scheme. Uptitration should not occur within 6 weeks of an efficacy assessment. Patients will be assessed for clinical worsening during each clinic visit. If clinical worsening is confirmed, the Investigator may opt to either continue treatment with APD811 at the current dose, increase the dose of APD811, interrupt treatment, or discontinue the patient at his/her discretion. In addition, all patients will be contacted yearly following discontinuation in Study APD811-007 to assess mortality status. The mortality status follow-up contact of patients who withdraw consent will depend on local regulations or specific agreement with the subject and investigator. After the last patient enrolled in Study APD811-007 has completed approximately 6 months of the study, a cumulative all-patient data analysis will be performed for all patients who entered the study. Patients will continue to have visits to the clinic every 3 months indefinitely to collect data until marketing approval of APD811 is granted or until the Sponsor discontinues the study. At the time of marketing approval or the Sponsor's decision to discontinue the study, all on-going patients will complete an End of Study Visit. A 28-day Follow-up Visit will be conducted to ensure appropriate subject safety.

Arms & Interventions

Arms

Experimental: Ralinepag

Ralinepag immediate release (IR) capsules of 0.01, 0.02, 0.03, 0.04 mg, and 0.10 mg per capsule or extended release (XR) tablets of 50, 250, and 400 mcg (0.05, 0.25 and 0.4 mg) for oral administration. The starting dose and titration schedule will be determined for each subject in accordance with the starting dose and titration schedule optimized from Study APD811-003.

Interventions

Drug: - Ralinepag

Active

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.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35249

Cedars-Sinai Medical Center, Beverly Hills, California

Status

Address

Cedars-Sinai Medical Center

Beverly Hills, California, 90211

David Geffen School of Medicine at UCLA, Los Angeles, California

Status

Address

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095

Sacramento, California

Status

Address

University of California Davis Medical Center

Sacramento, California, 95817

Harbor-UCLA Medical Center, Torrance, California

Status

Address

Harbor-UCLA Medical Center

Torrance, California, 90502

Aurora, Colorado

Status

Address

University of Colorado Cardiac and Vascular Center, Anschutz Inpatient Pavilion

Aurora, Colorado, 80045

Cleveland Clinic Florida, Weston, Florida

Status

Address

Cleveland Clinic Florida

Weston, Florida, 33331

University of Iowa Hospitals and Clinics, Iowa City, Iowa

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Address

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

Chest Medicine Associates, Portland, Maine

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Address

Chest Medicine Associates

Portland, Maine, 04106

University of Maryland Medical Center, Baltimore, Maryland

Status

Address

University of Maryland Medical Center

Baltimore, Maryland, 21201

Boston, Massachusetts

Status

Address

Boston University Medical Center General Clinical Research Unit (GCRU)

Boston, Massachusetts, 02118

University of Michigan Health System, Ann Arbor, Michigan

Status

Address

University of Michigan Health System

Ann Arbor, Michigan, 48109

UC Health, Cincinnati, Ohio

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Address

UC Health

Cincinnati, Ohio, 45219

University Hospitals Case Medical Center, Cleveland, Ohio

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Address

University Hospitals Case Medical Center

Cleveland, Ohio, 44106

Columbus, Ohio

Status

Address

The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion

Columbus, Ohio, 43221

UPMC, Presbytarian, Pittsburgh, Pennsylvania

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Address

UPMC, Presbytarian

Pittsburgh, Pennsylvania, 15229

UT Southwestern Medical Center, Dallas, Texas

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Address

UT Southwestern Medical Center

Dallas, Texas, 75390

Houston, Texas

Status

Address

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, 77030

International Sites

The Prince Charles Hospital, Chermside, Australia

Status

Address

The Prince Charles Hospital

Chermside, , 4032

Darlinghurst, Australia

Status

Address

St. Vincent's Hospital/Lung Transplant Unit

Darlinghurst, , 2010

St Vincent's Hospital, Fitzroy, Australia

Status

Address

St Vincent's Hospital

Fitzroy, , 3065

Royal Hobart Hospital, Hobart, Australia

Status

Address

Royal Hobart Hospital

Hobart, , 7000

Fiona Stanley Hospital, Murdoch, Australia

Status

Address

Fiona Stanley Hospital

Murdoch, , 6150

Pleven, Bulgaria

Status

Address

Multiprofile Hospital for Active Treatment in Cardiology EAD, Department of Cardiology

Pleven, , 5800

Sofia, Bulgaria

Status

Address

Multiprofile Hospital for Active Treatment "National Heart Hospital" EAD, Clinic of Cardiology

Sofia, , 1309

Sofia, Bulgaria

Status

Address

Multiprofile Hospital for Active Treatment " St. Anna", Sofia AD, Cardiology Clinic

Sofia, , 1750

Olomouc, Czechia

Status

Address

Department of Internal Medicine I - Cardiology, University Hospital Olomouc

Olomouc, , 77900

Prague, Czechia

Status

Address

Second Internal Clinic - Clinic of Cardiology and Angiology, 1st Faculty of Medicine, Charles University in Prague, General University Hospital in Prague

Prague, , 12808

Budapest, Hungary

Status

Address

Gottsegen Gyorgy Orszagos Kardiológiai lntézet National Institute of Cardiology, Department of Adult Cardiology

Budapest, , 1096

Budapest, Hungary

Status

Address

Semmelweis University, Department of Pulmonology - Semmelweis Egyetem Pulmonológiai Klinika

Budapest, , 1125

Debrecen, Hungary

Status

Address

University of Derecen Clinical Research Center Cardiology and Cardiac Surgery Department - Debreceni Egyetem Klinikai Kozpont Kardiologiai es Szivsebeszeti Klinika

Debrecen, , 4032

Pécs, Hungary

Status

Address

University of Pecs, Medical School, Heart Institute - Pécsi Tudományegyetem, Klinikai Központ, Szívgyógyászati Klinika

Pécs, , 7624

Szeged, Hungary

Status

Address

University of Szeged Faculty of Medicine, 2nd Department of Medicine and Cardiology Center, Albert Szent-Györyi Clinical Center - SZTE ÁOK Szent-Györgyi A lbert Klinikai Központ I I. sz. Belgyógyászati Klini ka és Kard ilógiai Központ

Szeged, , 6725

Białystok, Poland

Status

Address

Medical University of Bialystok Clinical Hospital Cardiology Clinic - Uniwersytecki Szpital Kliniczny, Klinika Kardiologii z Oddziałem Intensywnego Nadzoru Kardiologicznego

Białystok, , 15-276

Krakow, Poland

Status

Address

John Paul II Hospital in Cracov Department of Cardiac and Vascular Diseases - Krakowski Szpital Specjalistyczny im. Jana Pawła II, Oddział Kliniczny Chorób Serca i Naczyń

Krakow, , 31-202

Lodz, Poland

Status

Address

Biegański Provincial Specialist Hospital Department of Cardiology - Wojewódzki Szpital Specjalistyczny im. dr Wł. Biegańskiego w Lodzi, Oddział Kardiologiczny

Lodz, , 91-347

Bucharest, Romania

Status

Address

"Prof. Dr. C.C. Iliescu" Institute of Cardiovascular Diseases, Department of Clinic Cardiology III - Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Secţia Clinica Cardiologie fIJ

Bucharest, , 022322

Bucharest, Romania

Status

Address

"Marius Nasta" Institute of Pneumoftiziology, Department of Pneumoftiziology IV - Institutul de Pneumoftiziologie "Marius Nasta", Sectia Clinica Pneumoftiziologie IV

Bucharest, , 050159

Timisoara, Romania

Status

Address

"Dr. Victor Babes" Clinic Hospital for Infesctious Diseases and Pneumoftiziology, Department of Clinic Pneumology II

Timisoara, , 300310

Belgrade, Serbia

Status

Address

Clinical Centre of Serbia (CCS), Cardiology Clinic - Klinicki Centar SrЬije, Klinika za kardiologiju

Belgrade, , 11000

Belgrade, Serbia

Status

Address

Кlinjcko-bolnicki centar Zemun, Кlinika za internu medicmu, Sluzba za kardiologiju

Belgrade, , 11080

Sremska Kamenica, Serbia

Status

Address

Institute of Pulmonary Diseases of Vojvodina Sremska Kamenica (IPDVSK), The Clinic for Urgent Pulmonology, ICU - Intensive Care Unit - Klinicki Centar SrЬije, Klinika za kardiologiju

Sremska Kamenica, , 21204

Bratislava, Slovakia

Status

Address

Department of Heart Failure and Transplantation, National Institute of Cardiovascular Diseases - Oddelenie zlyhávania a transplantácie srdca, Národný ústav srdcových a cievnych chorôb, a.s.

Bratislava, , 833 48

Košice, Slovakia

Status

Address

Cardiology department, East Slovak Institute for Cardiovascular Diseases - Kardiologické oddelenie Klinika kardiológie , Východoslovenský ústav srdcových a cievnych chorôb, a.s

Košice, , 4011

Barcelona, Spain

Status

Address

General Universitary Hospital Vall d'Hebron, Department of Pneumology

Barcelona, , 08035

Barcelona, Spain

Status

Address

Clinic Hospital of Barcelona, Department of Pneumology

Barcelona, , 08036

Madrid, Spain

Status

Address

Hospital 12th of October, Department of Cardiology

Madrid, , 28041

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