Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension

NCT02279745 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: APD811-007
• Study Type: interventional
• Target: 45
• Locations: 10 countries
• Sites: 46

Brief Summary

This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) who have completed Study APD811-003, or who were assigned to receive placebo and were discontinued due to clinical worsening.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Pulmonary Vascular Resistance

  Pulmonary vascular resistance was collected by right heart catheterization (RHC).

  At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.

• Change From Baseline in Cardiac Output

  Cardiac output was collected by right heart catheterization (RHC).

  At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.

• Change From Baseline in Cardiac Index

  Cardiac index was collected by right heart catheterization (RHC).

  At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.

• Change From Baseline in Mean Pulmonary Arterial Pressure

  Mean pulmonary arterial pressure was collected by right heart catheterization (RHC).

  At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.

Secondary Outcomes (3)

• Time From Randomization to the First Protocol-defined Clinical Worsening Event

  From Baseline to 28 days following discontinuation of study drug, up to 235 weeks.

• Change From Baseline in 6MWD

  From Baseline to discontinuation of study drug, up to 235 weeks

• Change From Baseline in WHO/NYHA FC

  From Baseline to 28 days following discontinuation of study drug, up to 235 weeks

Study Arms (1)

Oral Ralinepag

EXPERIMENTAL

Ralinepag immediate-release (IR) capsules of 10, 20, 30, 40, and 100 mcg or extended-release (XR) tablets of 50, 250, and 400 mcg for oral administration.

Drug: Ralinepag

Interventions

Ralinepag DRUG

Active

Also known as: APD811

Oral Ralinepag

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of a personally signed and dated informed consent document.
• Was willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and was deemed an appropriate candidate for participation in a long-term extension study.
• Female subjects were nonpregnant, nonlactating, surgically sterile or postmenopausal, or agreed to use an accepted method of birth control for at least 3 months prior to the first dose, during, and for at least 30 days after the last dose of study drug.
• Male subjects were either surgically sterile or agreed to use a condom with spermicide when sexually active with a female partner who was not using an acceptable method of birth control during the study and for 30 days after the last dose of study drug.
• Male and female subjects agreed not to participate in a conception process during the study and for 30 days after the last dose of study drug.
• Fulfilled all eligibility criteria for Study APD811-003 and completed the study as planned.
• Subjects who were assigned to placebo in Study APD811-003 and experienced clinical worsening in that study could enroll in Study APD811-007 after completing all end of study procedures per protocol, including RHC, for Study APD811-003 and had their data locked.

You may not qualify if:

• Subjects who enrolled in Study APD811-003 and were withdrawn from study drug treatment due to any adverse event (AE), serious adverse event (SAE), or subjects who did not complete Study APD811003, with the exception made for placebo-treated subjects who experienced a clinical worsening event.
• Female •subjects who wished to become pregnant.
• Systolic blood pressure \<90 mmHg at Baseline.
• Other severe acute or chronic medical or laboratory abnormalities that could have increased the risk associated with study participation or investigational product administration or interfered with the interpretation of study results and, in the judgment of the investigator, would have made the subject inappropriate for entry into this study.

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (46)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Cedars-Sinai Medical Center

Beverly Hills, California, 90211, United States

Location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

University of Colorado Cardiac and Vascular Center, Anschutz Inpatient Pavilion

Aurora, Colorado, 80045, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Chest Medicine Associates

Portland, Maine, 04106, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Boston University Medical Center General Clinical Research Unit (GCRU)

Boston, Massachusetts, 02118, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

UC Health

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

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

Columbus, Ohio, 43221, United States

Location

UPMC, Presbyterian

Pittsburgh, Pennsylvania, 15229, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, 77030, United States

Location

St. Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7001, Australia

Location

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Fiona Stanley Hospital

Murdoch, 6150, Australia

Location

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

Sofia, 1000, Bulgaria

Location

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

Sofia, 1303, Bulgaria

Location

Department of Internal Medicine I - Cardiology, University Hospital Olomouc

Olomouc, 77900, Czechia

Location

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

Prague, 12808, Czechia

Location

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

Budapest, 1051, Hungary

Location

Semmelweis University, Department of Pulmonology - Semmelweis Egyetem Pulmonológiai Klinika

Budapest, 1051, Hungary

Location

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

Budapest, 1051, Hungary

Location

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

Budapest, 105, Hungary

Location

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

Debrecen, 4032, Hungary

Location

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

Krakow, 15-276, Poland

Location

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, Poland

Location

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

Lodz, 90-647, Poland

Location

"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, Romania

Location

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

Bucharest, 050159, Romania

Location

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

Timișoara, 300310, Romania

Location

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

Belgrade, 11000, Serbia

Location

Кlinicko-bolnicki Centar Zemun, Кlinika za internu medicinu, Sluzba za kardiologiju

Belgrade, 11080, Serbia

Location

Institut za plucne bolesti Vojvodine Sremska Kamenica, Klinika za urgcntnu pulmologiju, Odeljcnje intenzivne nege - Institute of Pulmonary Diseases of Vojvodina Sremska Kamenica (IPDVSK), The Clinic for Urgent Pulmonology, ICU - Intensive Care Unit

Kamenitz, 21204, Serbia

Location

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, Slovakia

Location

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

Košice, 4011, Slovakia

Location

Clinic Hospital of Barcelona, Department of Pneumology

Barcelona, 08036, Spain

Location

General University Hospital Vall d'Hebron, Department of Pneumology

Barcelona, 08036, Spain

Location

Hospital 12th of October, Department of Cardiology

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

ralinepag

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: United Therapeutics Corp.

clinicaltrials@unither.com

919-485-8350

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2014
• First Posted: October 31, 2014
• Study Start: July 8, 2015
• Primary Completion: March 29, 2021
• Study Completion: March 29, 2021
• Last Updated: December 22, 2021
• Results First Posted: December 22, 2021

Record last verified: 2021-11

Locations

CZ (2); AU (5); PL (3); SL (2); ES (3); US (18); RO (3); BU (2); HU (5); SE (3)