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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ralinepag
Sponsored by
United Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subjects who enrolled in Study APD811-003 and were withdrawn from study drug treatment due to any adverse event (AE), serious adverse event (SAE), or subjects who did not complete Study APD811003, with the exception made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.

Sites / Locations

  • University of Alabama at Birmingham
  • Cedars-Sinai Medical Center
  • David Geffen School of Medicine at UCLA
  • University of California Davis Medical Center
  • Harbor-UCLA Medical Center
  • University of Colorado Cardiac and Vascular Center, Anschutz Inpatient Pavilion
  • Cleveland Clinic Florida
  • University of Iowa Hospitals and Clinics
  • Chest Medicine Associates
  • University of Maryland Medical Center
  • Boston University Medical Center General Clinical Research Unit (GCRU)
  • University of Michigan Health System
  • UC Health
  • University Hospitals Case Medical Center
  • The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion
  • UPMC, Presbyterian
  • UT Southwestern Medical Center
  • Memorial Hermann Hospital - Texas Medical Center
  • St. Vincent's Hospital
  • The Prince Charles Hospital
  • Royal Hobart Hospital
  • St Vincent's Hospital
  • Fiona Stanley Hospital
  • Multiprofile Hospital for Active Treatment "National Heart Hospital" EAD, Clinic of Cardiology
  • Multiprofile Hospital for Active Treatment " St. Anna", Sofia AD, Cardiology Clinic
  • Department of Internal Medicine I - Cardiology, University Hospital Olomouc
  • Second Internal Clinic - Clinic of Cardiology and Angiology, 1st Faculty of Medicine, Charles University in Prague, General University Hospital in Prague
  • Gottsegen Gyorgy Orszagos Kardiológiai lntézet - National Institute of Cardiology, Department of Adult Cardiology
  • Semmelweis University, Department of Pulmonology - Semmelweis Egyetem Pulmonológiai Klinika
  • 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
  • University of Pecs, Medical School, Heart Institute - Pécsi Tudományegyetem, Klinikai Központ, Szívgyógyászati Klinika
  • University of Derecen Clinical Research Center Cardiology and Cardiac Surgery Department - Debreceni Egyetem Klinikai Kozpont Kardiologiai es Szivsebeszeti Klinika
  • 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
  • Medical University of Bialystok Clinical Hospital Cardiology Clinic - Uniwersytecki Szpital Kliniczny, Klinika Kardiologii z Oddziałem Intensywnego Nadzoru Kardiologicznego
  • Biegański Provincial Specialist Hospital Department of Cardiology - Wojewódzki Szpital Specjalistyczny im. dr Wł. Biegańskiego w Lodzi, Oddział Kardiologiczny
  • "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
  • "Marius Nasta" Institute of Pneumoftiziology, Department of Pneumoftiziology IV - Institutul de Pneumoftiziologie "Marius Nasta", Sectia Clinica Pneumoftiziologie IV
  • "Dr. Victor Babes" Clinic Hospital for Infesctious Diseases and Pneumoftiziology, Department of Clinic Pneumology II
  • Clinical Centre of Serbia (CCS), Cardiology Clinic - Klinicki Centar SrЬije, Klinika za kardiologiju
  • Кlinicko-bolnicki Centar Zemun, Кlinika za internu medicinu, Sluzba za kardiologiju
  • 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
  • Department of Heart Failure and Transplantation, National Institute of Cardiovascular Diseases - Oddelenie zlyhávania a transplantácie srdca, Národný ústav srdcových a cievnych chorôb, a.s.
  • Cardiology department, East Slovak Institute for Cardiovascular Diseases - Kardiologické oddelenie Klinika kardiológie , Východoslovenský ústav srdcových a cievnych chorôb, a.s
  • Clinic Hospital of Barcelona, Department of Pneumology
  • General University Hospital Vall d'Hebron, Department of Pneumology
  • Hospital 12th of October, Department of Cardiology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Ralinepag

Arm Description

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Pulmonary Vascular Resistance
Pulmonary vascular resistance was collected by right heart catheterization (RHC).
Change From Baseline in Cardiac Output
Cardiac output was collected by right heart catheterization (RHC).
Change From Baseline in Cardiac Index
Cardiac index was collected by right heart catheterization (RHC).
Change From Baseline in Mean Pulmonary Arterial Pressure
Mean pulmonary arterial pressure was collected by right heart catheterization (RHC).

Secondary Outcome Measures

Time From Randomization to the First Protocol-defined Clinical Worsening Event
Clinical worsening events were defined as death, or onset of a treatment-emergent adverse event (AE) with a fatal outcome occurring ≤14 days after treatment discontinuation; hospitalization for worsening PAH, heart-lung or lung transplant, or atrial septostomy; necessity of addition (or dose change) of any prostacyclin/prostacyclin analogue, phosphodiesterase type 5 inhibitor (PDE5-I) or soluble guanylate cyclase (sGC), or endothelin receptor antagonist (ERA); and the combined occurrence of a decrease in 6-Minute Walk Distance (6MWD) by at least 20% from Baseline, confirmed on two 6-Minute Walk Tests (6MWTs) on different days; worsening in WHO/New York Heart Association (NYHA) Functional Class (FC) from Baseline; and appearance of or worsening of signs/symptoms of right heart failure that did not respond to optimized oral diuretic therapy.
Change From Baseline in 6MWD
6MWD was measured at Baseline (prior to starting study drug) and every 3 months thereafter including the End of Study Visit.
Change From Baseline in WHO/NYHA FC
WHO/NYHA FC was measured at Baseline (prior to starting study drug) and every 3 months thereafter including at the End of Study and 28-Day Follow-up Visits. FC recorded as I, II, III, or IV based on the following: I: PH but without limitation of physical activity; physical activity without undue dyspnea or fatigue, chest pain or near syncope. II: PH with slight limitation of physical activity; physical activity causes undue dyspnea or fatigue, chest pain or near syncope. III: PH with marked limitation of physical activity; less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. IV: PH with inability to carry out any physical activity without symptoms. Signs of right heart failure. Dyspnea and/or fatigue at rest. Discomfort is increased by any physical activity.

Full Information

First Posted
October 25, 2014
Last Updated
November 23, 2021
Sponsor
United Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02279745
Brief Title
Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension
Official Title
An Open-label Extension Study of Ralinepag in Patients With Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 8, 2015 (Actual)
Primary Completion Date
March 29, 2021 (Actual)
Study Completion Date
March 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with WHO Group 1 PAH who completed Study APD811-003. Subjects who completed Study APD811-003 and met eligibility criteria for Study APD811-007 were enrolled. Additionally, placebo-treated subjects who discontinued study drug treatment due to clinical worsening in Study APD811-003 were permitted to enroll in Study APD811-007, upon approval of the medical monitor, provided that all end of study procedures including right heart catheterization (RHC) were performed per the study protocol. The Week 25 Visit in Study APD811-003 served as the Baseline Visit for Study APD811-007. All subjects enrolled in Study APD811-007 received open-label treatment with ralinepag. The starting dose and titration schedule were individually determined and in accordance with the starting dose and titration schedule optimized from Study APD811-003. Adjustments in the dose and titration schedule were made according to subject tolerability. After an individual subject completed Study APD811-003 and that subject's database was locked, subject unblinding occurred. Subjects on active treatment (ralinepag) remained on their current dose and had onsite clinical assessments performed every 3 months until the subject was discontinued from the study. Subjects in the placebo treatment group underwent a dose titration period until a stable, maximum tolerated dose (MTD) was reached (up to 9 weeks), followed by a treatment period after the MTD was determined during which monthly onsite clinic assessments were performed for the first 3 months and then every 3 months until the subject was discontinued from the study or the study was terminated. Dose reductions could be made at any time for safety reasons. Incremental dose increases were also allowed during the Treatment Period at the discretion of the Investigator (as clinically indicated) and according to the stepwise titration scheme. Subjects were assessed for clinical worsening during each clinic visit. If clinical worsening was confirmed, the Investigator could have opted to either continue treatment with ralinepag at the current dose, increase the dose of ralinepag, interrupt treatment, or discontinue the subject at his/her discretion. In addition, attempts were made to contact all subjects at the time of Study APD811-007 termination to assess their vital (mortality) status. After the last subject enrolled in Study APD811-007 completed approximately 6 months of the study, a cumulative all-subject data analysis was performed for all subjects who entered the study. Subjects continued to have visits to the clinic every 3 months until the Sponsor discontinued the study. At the time of the Sponsor's decision to discontinue the study, all ongoing subjects completed an End of Study Visit. A 28-day Follow-up Visit was conducted to ensure appropriate subject safety. Subjects who remained on ralinepag were eligible to transition into the Phase 3 open-label extension study (ROR-PH-303) prior to APD811-007 study termination. For those subjects that did not enroll in Study ROR-PH-303, a 28-day Follow-up Visit was conducted to evaluate ongoing subject safety, including survival status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Ralinepag
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ralinepag
Other Intervention Name(s)
APD811
Intervention Description
Active
Primary Outcome Measure Information:
Title
Change From Baseline in Pulmonary Vascular Resistance
Description
Pulmonary vascular resistance was collected by right heart catheterization (RHC).
Time Frame
At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.
Title
Change From Baseline in Cardiac Output
Description
Cardiac output was collected by right heart catheterization (RHC).
Time Frame
At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.
Title
Change From Baseline in Cardiac Index
Description
Cardiac index was collected by right heart catheterization (RHC).
Time Frame
At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.
Title
Change From Baseline in Mean Pulmonary Arterial Pressure
Description
Mean pulmonary arterial pressure was collected by right heart catheterization (RHC).
Time Frame
At 1 or 2 years after the subject enrolled into the study, pending their last RHC prior to Protocol Amendment 2.
Secondary Outcome Measure Information:
Title
Time From Randomization to the First Protocol-defined Clinical Worsening Event
Description
Clinical worsening events were defined as death, or onset of a treatment-emergent adverse event (AE) with a fatal outcome occurring ≤14 days after treatment discontinuation; hospitalization for worsening PAH, heart-lung or lung transplant, or atrial septostomy; necessity of addition (or dose change) of any prostacyclin/prostacyclin analogue, phosphodiesterase type 5 inhibitor (PDE5-I) or soluble guanylate cyclase (sGC), or endothelin receptor antagonist (ERA); and the combined occurrence of a decrease in 6-Minute Walk Distance (6MWD) by at least 20% from Baseline, confirmed on two 6-Minute Walk Tests (6MWTs) on different days; worsening in WHO/New York Heart Association (NYHA) Functional Class (FC) from Baseline; and appearance of or worsening of signs/symptoms of right heart failure that did not respond to optimized oral diuretic therapy.
Time Frame
From Baseline to 28 days following discontinuation of study drug, up to 235 weeks.
Title
Change From Baseline in 6MWD
Description
6MWD was measured at Baseline (prior to starting study drug) and every 3 months thereafter including the End of Study Visit.
Time Frame
From Baseline to discontinuation of study drug, up to 235 weeks
Title
Change From Baseline in WHO/NYHA FC
Description
WHO/NYHA FC was measured at Baseline (prior to starting study drug) and every 3 months thereafter including at the End of Study and 28-Day Follow-up Visits. FC recorded as I, II, III, or IV based on the following: I: PH but without limitation of physical activity; physical activity without undue dyspnea or fatigue, chest pain or near syncope. II: PH with slight limitation of physical activity; physical activity causes undue dyspnea or fatigue, chest pain or near syncope. III: PH with marked limitation of physical activity; less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. IV: PH with inability to carry out any physical activity without symptoms. Signs of right heart failure. Dyspnea and/or fatigue at rest. Discomfort is increased by any physical activity.
Time Frame
From Baseline to 28 days following discontinuation of study drug, up to 235 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado Cardiac and Vascular Center, Anschutz Inpatient Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Chest Medicine Associates
City
Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Boston University Medical Center General Clinical Research Unit (GCRU)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
UC Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
UPMC, Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15229
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Memorial Hermann Hospital - Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7001
Country
Australia
Facility Name
St Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Multiprofile Hospital for Active Treatment "National Heart Hospital" EAD, Clinic of Cardiology
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment " St. Anna", Sofia AD, Cardiology Clinic
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
Department of Internal Medicine I - Cardiology, University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Second Internal Clinic - Clinic of Cardiology and Angiology, 1st Faculty of Medicine, Charles University in Prague, General University Hospital in Prague
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Gottsegen Gyorgy Orszagos Kardiológiai lntézet - National Institute of Cardiology, Department of Adult Cardiology
City
Budapest
ZIP/Postal Code
1051
Country
Hungary
Facility Name
Semmelweis University, Department of Pulmonology - Semmelweis Egyetem Pulmonológiai Klinika
City
Budapest
ZIP/Postal Code
1051
Country
Hungary
Facility Name
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
City
Budapest
ZIP/Postal Code
1051
Country
Hungary
Facility Name
University of Pecs, Medical School, Heart Institute - Pécsi Tudományegyetem, Klinikai Központ, Szívgyógyászati Klinika
City
Budapest
ZIP/Postal Code
105
Country
Hungary
Facility Name
University of Derecen Clinical Research Center Cardiology and Cardiac Surgery Department - Debreceni Egyetem Klinikai Kozpont Kardiologiai es Szivsebeszeti Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
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
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Medical University of Bialystok Clinical Hospital Cardiology Clinic - Uniwersytecki Szpital Kliniczny, Klinika Kardiologii z Oddziałem Intensywnego Nadzoru Kardiologicznego
City
Kraków
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Biegański Provincial Specialist Hospital Department of Cardiology - Wojewódzki Szpital Specjalistyczny im. dr Wł. Biegańskiego w Lodzi, Oddział Kardiologiczny
City
Lodz
ZIP/Postal Code
90-647
Country
Poland
Facility Name
"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
City
Bucharest
ZIP/Postal Code
022322
Country
Romania
Facility Name
"Marius Nasta" Institute of Pneumoftiziology, Department of Pneumoftiziology IV - Institutul de Pneumoftiziologie "Marius Nasta", Sectia Clinica Pneumoftiziologie IV
City
Bucharest
ZIP/Postal Code
050159
Country
Romania
Facility Name
"Dr. Victor Babes" Clinic Hospital for Infesctious Diseases and Pneumoftiziology, Department of Clinic Pneumology II
City
Timisoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
Clinical Centre of Serbia (CCS), Cardiology Clinic - Klinicki Centar SrЬije, Klinika za kardiologiju
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Кlinicko-bolnicki Centar Zemun, Кlinika za internu medicinu, Sluzba za kardiologiju
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
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
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Department of Heart Failure and Transplantation, National Institute of Cardiovascular Diseases - Oddelenie zlyhávania a transplantácie srdca, Národný ústav srdcových a cievnych chorôb, a.s.
City
Bratislava
ZIP/Postal Code
833 48
Country
Slovakia
Facility Name
Cardiology department, East Slovak Institute for Cardiovascular Diseases - Kardiologické oddelenie Klinika kardiológie , Východoslovenský ústav srdcových a cievnych chorôb, a.s
City
Košice
ZIP/Postal Code
4011
Country
Slovakia
Facility Name
Clinic Hospital of Barcelona, Department of Pneumology
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
General University Hospital Vall d'Hebron, Department of Pneumology
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital 12th of October, Department of Cardiology
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

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

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