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A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH (CAPACITY)

Primary Purpose

PAH, Pulmonary Hypertension, Hypertension

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ralinepag
Placebo
Sponsored by
United Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PAH focused on measuring Prostacyclin, Connective Tissue Disease-Associated, Cardiopulmonary Exercise Capacity (CPET), IP Receptor Agonist

Eligibility Criteria

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

Inclusion Criteria:

  1. Signed informed consent form.
  2. At least 18 years of age.
  3. Primary diagnosis of PAH.
  4. Has had a diagnostic RHC performed at or within 3 years before Screening (or at Screening if one is not available) that is consistent with the diagnosis of PAH.
  5. Has World Health Organization (WHO)/New York Heart Association (NYHA) Functional Class (FC) II to III symptoms
  6. Must be on a stable dose of PAH-specific oral therapy, defined as no change in dose or regimen for at least 90 days prior to randomization. Allowable PAH-specific therapy is an endothelin receptor antagonist and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator. Subjects may be on a stable dose of either a PDE5-I or a sGC stimulator, not both.
  7. Has a 6-minute walk distance (6MWD) of ≥150 meters at Screening.
  8. Has a peak VO2 of ≥9 to <18 mL/min/kg during the Screening CPET, as assessed by the CPET core laboratory.
  9. If the subject is taking concomitant medications that may affect the clinical manifestations of PAH, the subject must be on a stable dose for at least 30 days prior to randomization. The exception is that the dose of diuretics must be stable for at least the 10 days prior to randomization.
  10. Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through to the Week 28 Visit/28-day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process during the study and for 30 days after the final dose of study drug. Eligible male subjects must agree not to participate in sperm donation for 90 days after the final dose of study drug. Women who are surgically sterile or postmenopausal are not considered to be of childbearing potential. If of childbearing potential, female partners of male study participants should agree to utilize medically acceptable methods of contraception for the duration of study participation.

Exclusion Criteria:

  1. For subjects with known human immunodeficiency virus-associated PAH, a cluster of differentiation 4 T-cell count <200/mm3 at Screening.
  2. Has 3 or more left ventricular disease/dysfunction risk factors.
  3. Symptomatic coronary artery disease and/or myocardial infarction within past 6 months.
  4. Current symptomatic aortic or mitral valve disease.
  5. Has evidence of more than mild lung disease on pulmonary function tests performed within 1 year prior to, or during, Screening.
  6. Has evidence of thromboembolic disease as determined by ventilation-perfusion lung scan or local standard of care diagnostic evaluation at or after diagnosis of PAH.
  7. Current diagnosis of ongoing and clinically significant sleep apnea as defined by the Investigator.
  8. Requires use of supplemental oxygen during CPET.
  9. Respiratory exchange ratio <1.0 at Screening CPET as determined by the CPET core laboratory.
  10. Acute non-cardiac disorder that may affect exercise performance or be aggravated by exercise (eg, infection, renal failure, thyrotoxicosis).
  11. Male subjects with a QTcF >450 msec and female subjects with a QTcF >470 msec on electrocardiogram (ECG) recorded at Screening and analyzed by the central ECG laboratory. Subjects with evidence of intraventricular conduction delay, defined as a QRS interval >110 msec, will be excluded if QTcF is >500 msec for both males and females.
  12. Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis, or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy).
  13. Confirmed active infection with hepatitis B virus or hepatitis C virus.
  14. Subjects with alanine aminotransferase or aspartate aminotransferase ≥3 times the upper limit of normal or total bilirubin ≥2 times the upper limit of normal at Screening.
  15. Chronic renal insufficiency as defined by an estimated glomerular filtration rate using the Modification of Diet in Renal Disease Study equation of <30 mL/min/1.73 m2 or requiring dialysis at Screening.
  16. Hemoglobin concentration <9 g/dL at Screening.
  17. Subjects treated with an intravenous, subcutaneous, inhaled, or oral prostacyclin pathway agent (eg, epoprostenol, treprostinil, iloprost, beraprost, or selexipag) for PAH within 90 days of randomization (use in vasoreactive testing is permitted). Subject is not eligible if previous prostacyclin therapy was stopped for a safety or tolerability issue related to systemic prostacyclin adverse effects.
  18. Subject has pulmonary veno-occlusive disease.
  19. Malignancy diagnosed and/or treated within 3 years of Screening, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent.
  20. Subject tests positive for amphetamine, cocaine, methamphetamine, methylenedioxymethamphetamine, or phencyclidine in urine drug screen performed at Screening, or has a recent history (6 months) of alcohol or drug abuse. Subjects will not be excluded due to a positive drug screen caused by prescribed medications.
  21. Initiation or discontinuation of a cardio-pulmonary rehabilitation program based upon exercise within 90 days prior to Screening and/or planned during study participation.
  22. Prior participation in any study of ralinepag or another interventional clinical study with medicinal products within 30 days prior to Screening. Concurrent participation in registry or observational studies is allowed, if the subject can fulfill all other entry criteria and comply with all study procedures.
  23. Any reason that, in the opinion of the Investigator, precludes the subject from participating in the study (eg, any previous or intercurrent medical condition) that may increase the risk associated with study participation or that would confound study analysis (eg, right-to-left shunt detected during CPET) or impair study participation or cooperation.
  24. Known hypersensitivity to ralinepag or any of the excipients.
  25. Life expectancy <12 months based on the Investigator's opinion.
  26. Women who are pregnant, lactating, or breast-feeding.

Sites / Locations

  • Banner University Medical Center (University of Arizona)
  • University of Colorado Anschutz Medical Campus
  • National Jewish Health
  • Tampa General Hospital/University of South Florida Center for Advanced Lung Disease and Lung Transplant
  • Medical College of Wisconsin/Froedtert Hospital
  • Hospital Britanico de Buenos Aires
  • Instituto de Cardiología de Corrientes
  • Macquarie University
  • Westmead Hospital, Dept Respiratory and Sleep Medicine
  • The Prince Charles Hospital
  • Princess Alexandra Hospital
  • Ordensklinikum Linz GmbH, Elisabethinen
  • AKH Wien, Innere Med. II, Kardiologie
  • Erasme University Hospital - Department of Cardiology
  • Gasthuisberg University Hospital - Department of Pulmonology
  • Hospital Madre Teresa
  • Hospital Sao Paulo
  • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo - InCor-HCFMUSP
  • Centro de Hipertensão Pulmonar
  • Peter Lougheed Center
  • University of Alberta Hospital
  • London Health Science Centre- Victoria Hospital
  • Thoraxklinik-Heidelberg, Zentrum für Pulmonale Hypertonie
  • Universitätsklinikum Carl Gustav Carus TU Dresden, Medizinische Klinik I, Abteilung für Pneumologie
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Centro Cardiologico Monzino, IRCCS
  • AOU Policlinico Umberto I
  • Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Kardiologii z Oddziałem Intensywnego Nadzoru Kardiologicznego
  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Oddział Kardiologiczny
  • Hospital Universitari Vall d'Hebron
  • Hospital Clínic I Provincial de Barcelona
  • Hospital Universitario 12 de Octubre
  • Imperial college Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ralinepag

Placebo

Arm Description

Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the individual maximum tolerated dose (maximum dose of 1400 mcg)

Matching placebo tablets (oral)

Outcomes

Primary Outcome Measures

Change from Baseline in peak VO2 assessed by CPET
Peak VO2 by CPET was measured at Baseline (prior to starting study drug) and Week 28

Secondary Outcome Measures

Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
NT-proBNP was measured at Baseline (prior to starting study drug) and Weeks 4, 8, 12, 16, 20, 24 and 28
Change from Baseline in Minute Ventilation (VE)/Carbon Dioxide output (VCO2) slope
VE/VCO2 slope (from CPET) was calculated at Baseline (prior to starting study drug) and Week 28
Change from Baseline in health-related quality of life measured by the Short Form Health Survey (SF-36) Scores
SF-36 was assessed at Baseline (prior to starting study drug) and Weeks 16 and 28. The SF-36 consisted of 36 questions in 8 health categories (Vitality, Physical Functioning, Bodily Pain, General Health Perception, Role Physical, Role Emotional, Social Functioning, and Mental Health). Responses to the questions were graded on a numerical scale, with 1 as the best score and higher numbers as worse scores. The raw scores from the subscales were converted and summed by the Investigator to a total score between 0 and 100 to measure functional health and well-being from the patient's point of view. The final score range was 0 (representing the lowest possible score; worst health state) to 100 (representing the highest possible score; best health state).
Time to First All-cause Non-elective Hospitalization
The time to first all-cause nonelective hospitalization during the study period will be assessed.

Full Information

First Posted
September 6, 2019
Last Updated
October 19, 2023
Sponsor
United Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04084678
Brief Title
A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH
Acronym
CAPACITY
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by CPET in Subjects With WHO Group 1 Pulmonary Hypertension Who Recently Initiated Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
April 12, 2023 (Actual)
Study Completion Date
April 12, 2023 (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
Study ROR-PH-302, ADVANCE CAPACITY, is designed to evaluate the effects of ralinepag therapy on exercise capacity as assessed by change in peak oxygen consumption (VO2) derived from cardiopulmonary exercise testing (CPET) after 28 weeks of treatment
Detailed Description
ROR-PH-302 is a 28-week multicenter, randomized, double-blind, placebo-controlled study. Subjects who meet entry criteria will be randomly allocated 2:1 to receive ralinepag or placebo, in addition to their PAH-specific background therapy, as applicable. The primary endpoint is change from Baseline in peak VO2 (assessed by CPET) at Week 28. All subjects who complete the study on study drug through Week 28 will have the option to receive ralinepag in an open-label extension (OLE) study. Subjects who discontinue study drug prior to Week 28, as well as those who complete Week 28 on study drug but choose not to participate in the OLE study, will be contacted every 6 months and at the end of the study to determine their survival status. Subjects who prematurely discontinue study drug or withdraw from the study for any reason will not be eligible to enter the OLE study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PAH, Pulmonary Hypertension, Hypertension, Connective Tissue Disease, Familial Primary Pulmonary Hypertension, Vascular Diseases, Cardiovascular Diseases, Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Disease, Pulmonary Arterial Hypertension
Keywords
Prostacyclin, Connective Tissue Disease-Associated, Cardiopulmonary Exercise Capacity (CPET), IP Receptor Agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ralinepag
Arm Type
Experimental
Arm Description
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the individual maximum tolerated dose (maximum dose of 1400 mcg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets (oral)
Intervention Type
Drug
Intervention Name(s)
Ralinepag
Other Intervention Name(s)
APD811
Intervention Description
Oral ralinepag
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching oral tablets
Primary Outcome Measure Information:
Title
Change from Baseline in peak VO2 assessed by CPET
Description
Peak VO2 by CPET was measured at Baseline (prior to starting study drug) and Week 28
Time Frame
Baseline to Week 28
Secondary Outcome Measure Information:
Title
Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Description
NT-proBNP was measured at Baseline (prior to starting study drug) and Weeks 4, 8, 12, 16, 20, 24 and 28
Time Frame
Baseline to Week 28
Title
Change from Baseline in Minute Ventilation (VE)/Carbon Dioxide output (VCO2) slope
Description
VE/VCO2 slope (from CPET) was calculated at Baseline (prior to starting study drug) and Week 28
Time Frame
Baseline to Week 28
Title
Change from Baseline in health-related quality of life measured by the Short Form Health Survey (SF-36) Scores
Description
SF-36 was assessed at Baseline (prior to starting study drug) and Weeks 16 and 28. The SF-36 consisted of 36 questions in 8 health categories (Vitality, Physical Functioning, Bodily Pain, General Health Perception, Role Physical, Role Emotional, Social Functioning, and Mental Health). Responses to the questions were graded on a numerical scale, with 1 as the best score and higher numbers as worse scores. The raw scores from the subscales were converted and summed by the Investigator to a total score between 0 and 100 to measure functional health and well-being from the patient's point of view. The final score range was 0 (representing the lowest possible score; worst health state) to 100 (representing the highest possible score; best health state).
Time Frame
Baseline to Week 28
Title
Time to First All-cause Non-elective Hospitalization
Description
The time to first all-cause nonelective hospitalization during the study period will be assessed.
Time Frame
Baseline to Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent form. At least 18 years of age. Primary diagnosis of PAH. Has had a diagnostic RHC performed at or within 3 years before Screening (or at Screening if one is not available) that is consistent with the diagnosis of PAH. Has World Health Organization (WHO)/New York Heart Association (NYHA) Functional Class (FC) II to III symptoms Must be on a stable dose of PAH-specific oral therapy, defined as no change in dose or regimen for at least 90 days prior to randomization. Allowable PAH-specific therapy is an endothelin receptor antagonist and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator. Subjects may be on a stable dose of either a PDE5-I or a sGC stimulator, not both. Has a 6-minute walk distance (6MWD) of ≥150 meters at Screening. Has a peak VO2 of ≥9 to <18 mL/min/kg during the Screening CPET, as assessed by the CPET core laboratory. If the subject is taking concomitant medications that may affect the clinical manifestations of PAH, the subject must be on a stable dose for at least 30 days prior to randomization. The exception is that the dose of diuretics must be stable for at least the 10 days prior to randomization. Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through to the Week 28 Visit/28-day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process during the study and for 30 days after the final dose of study drug. Eligible male subjects must agree not to participate in sperm donation for 90 days after the final dose of study drug. Women who are surgically sterile or postmenopausal are not considered to be of childbearing potential. If of childbearing potential, female partners of male study participants should agree to utilize medically acceptable methods of contraception for the duration of study participation. Exclusion Criteria: For subjects with known human immunodeficiency virus-associated PAH, a cluster of differentiation 4 T-cell count <200/mm3 at Screening. Has 3 or more left ventricular disease/dysfunction risk factors. Symptomatic coronary artery disease and/or myocardial infarction within past 6 months. Current symptomatic aortic or mitral valve disease. Has evidence of more than mild lung disease on pulmonary function tests performed within 1 year prior to, or during, Screening. Has evidence of thromboembolic disease as determined by ventilation-perfusion lung scan or local standard of care diagnostic evaluation at or after diagnosis of PAH. Current diagnosis of ongoing and clinically significant sleep apnea as defined by the Investigator. Requires use of supplemental oxygen during CPET. Respiratory exchange ratio <1.0 at Screening CPET as determined by the CPET core laboratory. Acute non-cardiac disorder that may affect exercise performance or be aggravated by exercise (eg, infection, renal failure, thyrotoxicosis). Male subjects with a QTcF >450 msec and female subjects with a QTcF >470 msec on electrocardiogram (ECG) recorded at Screening and analyzed by the central ECG laboratory. Subjects with evidence of intraventricular conduction delay, defined as a QRS interval >110 msec, will be excluded if QTcF is >500 msec for both males and females. Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis, or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy). Confirmed active infection with hepatitis B virus or hepatitis C virus. Subjects with alanine aminotransferase or aspartate aminotransferase ≥3 times the upper limit of normal or total bilirubin ≥2 times the upper limit of normal at Screening. Chronic renal insufficiency as defined by an estimated glomerular filtration rate using the Modification of Diet in Renal Disease Study equation of <30 mL/min/1.73 m2 or requiring dialysis at Screening. Hemoglobin concentration <9 g/dL at Screening. Subjects treated with an intravenous, subcutaneous, inhaled, or oral prostacyclin pathway agent (eg, epoprostenol, treprostinil, iloprost, beraprost, or selexipag) for PAH within 90 days of randomization (use in vasoreactive testing is permitted). Subject is not eligible if previous prostacyclin therapy was stopped for a safety or tolerability issue related to systemic prostacyclin adverse effects. Subject has pulmonary veno-occlusive disease. Malignancy diagnosed and/or treated within 3 years of Screening, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent. Subject tests positive for amphetamine, cocaine, methamphetamine, methylenedioxymethamphetamine, or phencyclidine in urine drug screen performed at Screening, or has a recent history (6 months) of alcohol or drug abuse. Subjects will not be excluded due to a positive drug screen caused by prescribed medications. Initiation or discontinuation of a cardio-pulmonary rehabilitation program based upon exercise within 90 days prior to Screening and/or planned during study participation. Prior participation in any study of ralinepag or another interventional clinical study with medicinal products within 30 days prior to Screening. Concurrent participation in registry or observational studies is allowed, if the subject can fulfill all other entry criteria and comply with all study procedures. Any reason that, in the opinion of the Investigator, precludes the subject from participating in the study (eg, any previous or intercurrent medical condition) that may increase the risk associated with study participation or that would confound study analysis (eg, right-to-left shunt detected during CPET) or impair study participation or cooperation. Known hypersensitivity to ralinepag or any of the excipients. Life expectancy <12 months based on the Investigator's opinion. Women who are pregnant, lactating, or breast-feeding.
Facility Information:
Facility Name
Banner University Medical Center (University of Arizona)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Tampa General Hospital/University of South Florida Center for Advanced Lung Disease and Lung Transplant
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Medical College of Wisconsin/Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hospital Britanico de Buenos Aires
City
Ciudad Autónoma de Bs. As.
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Instituto de Cardiología de Corrientes
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Facility Name
Macquarie University
City
North Ryde
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Westmead Hospital, Dept Respiratory and Sleep Medicine
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Ordensklinikum Linz GmbH, Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
AKH Wien, Innere Med. II, Kardiologie
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Erasme University Hospital - Department of Cardiology
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Gasthuisberg University Hospital - Department of Pulmonology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hospital Madre Teresa
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30441-070
Country
Brazil
Facility Name
Hospital Sao Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04037-002
Country
Brazil
Facility Name
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo - InCor-HCFMUSP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Centro de Hipertensão Pulmonar
City
Porto Alegre
ZIP/Postal Code
90035074
Country
Brazil
Facility Name
Peter Lougheed Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
London Health Science Centre- Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Thoraxklinik-Heidelberg, Zentrum für Pulmonale Hypertonie
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus TU Dresden, Medizinische Klinik I, Abteilung für Pneumologie
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Centro Cardiologico Monzino, IRCCS
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
AOU Policlinico Umberto I
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Kardiologii z Oddziałem Intensywnego Nadzoru Kardiologicznego
City
Białystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Oddział Kardiologiczny
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Imperial college Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH

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