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A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain (ORCHESTRA)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Macitentan
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring PAH-SYMPACT, psychometric instrument

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent prior to initiation of any study-mandated procedure.
  2. Patients with symptomatic PAH in WHO Functional Class (FC) II or III.
  3. Patients with PAH belonging to one of the following subgroups of the Dana Point Clinical Classification Group 1:

    1. Idiopathic, or,
    2. Heritable, or,
    3. Drug or toxin induced, or,
    4. Associated with one of the following:

    i. Connective tissue disease, ii. Congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair, iii. HIV infection.

  4. Documented hemodynamic diagnosis of PAH by right heart catheterization - performed at any time prior to Screening showing:

    1. Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and,
    2. Resting pulmonary vascular resitance (PVR) > 240 dyn.s.cm-5 and,
    3. Pulmonary capillary wede pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg.
  5. 6-minute walk distance (6MWD) ≥ 150 m at Screening.
  6. Able to fluently speak and read the local language.
  7. Men or women aged 18-80; women of childbearing potential (as defined below) must:

    1. Have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to perform monthly serum pregnancy tests, and,
    2. Agree to use two reliable methods of contraception in parallel, from Screening Visit 1 until 1 month after study drug discontinuation (see details below).

      • A female is considered to have childbearing potential unless she meets at least one of the following criteria:

        • Previous bilateral salpingo and/or oophorectomy, or hysterectomy.
        • Premature ovarian failure confirmed by a specialist.
        • Pre-pubescence, XY genotype, Turner syndrome, uterine agenesis.
        • Postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause.
      • Of the two contraceptive methods that must be used, one must be from Group 1, and one must be from Group 2, defined as follows:

        • Group 1: Oral, implantable, transdermal or injectable hormonal contraceptives, intrauterine devices, female sterilization (tubal ligation or non surgical sterilization, e.g., permanent contraception with Essure procedure), or partner's sterilization (vasectomy). If a hormonal contraceptive is chosen from this group, it must be taken for at least 1 month prior to enrollment. Alternatively, if the Essure procedure is chosen as a contraceptive method, a hysterosalpingogram must have been performed to confirm correct location of the microinserts and tubal occlusion (as per manufacturer's recommendations).
        • Group 2: Female or male condoms, diaphragm or cervical cap, any of them in combination with a spermicide.
      • Sexual abstinence, rhythm methods, or contraception by the partner alone are not considered as acceptable methods of contraception for this study.

Exclusion Criteria:

  1. Known moderate-to-severe obstructive lung disease (i.e., forced expiratory volume in one second [FEV1] < 80 % of predicted, with FEV1 / forced vital capacity [FVC] < 70%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema).
  2. Known moderate-to-severe restrictive lung disease (i.e., total lung capacity [TLC] < 60% of predicted value).
  3. Hemoglobin < 100g/L at Screening.
  4. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 X upper limit of the normal range (ULN) at Screening.
  5. Patients undergoing dialysis.
  6. Systolic blood pressure (SBP) < 90 mmHg at Screening.
  7. Body weight < 40 kg at Screening.
  8. Known concomitant life-threatening diseases with a life expectancy of < 12 months.
  9. Treatment with ERAs within 3 months prior to Visit 2, or scheduled to receive any of these compounds, other than macitentan, during the trial.
  10. Treatment with intravenous or subcutaneous prostacyclin or prostacyclin analogs within 3 months prior to Visit 2, or scheduled to receive any of these compounds during the trial.
  11. Treatment with soluble guanylate cyclase stimulator (riociguat) within 3 months prior to Visit 2, or scheduled to receive riociguat during the trial.
  12. Patients who changed the dose of or discontinued phosphodiesterase type-5 inhibitor (PDE5i), inhaled prostacyclin analogues, or calcium channel blockers within 3 months prior to Visit 2.
  13. Initiation of diuretics within 1 week prior to the Baseline period.
  14. Patients on oral diuretics in whom the dose has not been stable for at least 1 week prior to the Baseline period.
  15. Treatment with cytochrome P4500 (CYP) 3A inducers within 4 weeks prior to Visit 2.
  16. Recently started (< 8 weeks prior to Visit 2) or planned cardio-pulmonary rehabilitation program based on exercise.
  17. Females who are lactating or pregnant (positive Screening or Baseline pregnancy test) or plan to become pregnant during the study.
  18. Known hypersensitivity to macitentan or its excipients or drugs of the same class.
  19. Treatment with another investigational drug within 3 months prior to Visit 2.
  20. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.

Sites / Locations

  • Hôpital de Haut Levêque
  • Hôpital Côte de Nacre
  • Hôpital Albert Michallon
  • CHU de Bicêtre
  • CHRU Lille - Hôpital Cardiologique
  • Hôpital Louis Pradel
  • Hôpital Arnaud de Villeneuve
  • Hôpitaux de Brabois
  • Hôpital Pontchaillou
  • Hôpital Charles Nicolle
  • Hôpital Nord
  • Hôpital Civil
  • Hôpital Larrey
  • Universita degli Studi di Bari
  • Ospedale di Venere
  • Ospedale Sant'Orsola
  • A.O.U.C. Careggi
  • Milan Sacco Hospital
  • AORN Azienda Ospedaliera dei Colli
  • Ambulatorio Scompenso Cardiaco e Trapiant
  • Istituto di Fisiologia clinica - CNR
  • Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare
  • UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica
  • Ospedale "S. Maria di Cà Foncello"
  • Policlinico G.B. Rossi
  • Hospital Universitario Insular Gran Canarias
  • Hospital General de Alicante
  • Hospital Val Hebron
  • Hospital Clinic
  • Hospital de Cruces
  • Hospital Reina Sofia
  • Hospital Dr Negrin
  • Hospital 12 Octubre
  • Hospital La Paz
  • Hospital Carlos Haya
  • Hospital Son Espases
  • Hospital de Valdecilla
  • Hospital Virgen del Rocio
  • Hospita General U. Valencia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Macitentan

Arm Description

Macitentan tablet, dose of 10 mg, once daily

Outcomes

Primary Outcome Measures

Evaluation of the Reliability and the Construct Validity of the Cardiopulmonary Symptoms Domain of the PAH-SYMPACT
The Cardiopulmonary Symptoms domain consists of 6 items reported on a 5-point Likert scale (from 0 to 4). The value 0 means "no symptom" and value 4 corresponds to "very severe symptoms".The symptoms part of the PAH-SYMPACT was administered daily over a 7 day period. The recall period of symptom items is the last 24 hours. An average Cardiopulmonary Symptoms domain score is determined based on the daily scores of the 6 items. It was administered two times (daily during 7 days each time) prior to administration of Macitentan (Visit 2, Baseline) and daily during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16).
Evaluation of the Reliability and the Construct Validity of the Cardiovascular Symptoms Domain of the PAH-SYMPACT
The Cardiovascular Symptoms domain consists of 5 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "no symptoms" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH-SYMPACT was administered daily over a 7 day period. The recall period of symptom items is the last 24 hours. An average Cardiovascular Symptoms domain score is determined based on the daily scores of the 5 items. It was administered two times (daily during 7 days each time) prior to administration of Macitentan (Visit 2, Baseline) and daily during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16).
Evaluation of the Reliability and the Construct Validity of the Physical Impacts Domain of the PAH-SYMPACT
The Physical Impacts domain consists of 7 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "not at all"/"with no difficulty at all" and value 4 corresponds to "very much"/"extremely"/ "not able at all". The impacts part of the PAH-SYMACT was administered on Day 7 of the symptoms part administration. Items in the impact part have a 7 day recall period. An average Physical Impacts domain score is determined based on the 7 items in the domain. It was administered two times prior to administration of Macitentan (Visit 2, Baseline) and during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16).
Evaluation of the Reliability and the Construct Validity of the Cognitive/Emotional Impacts Domain of the PAH-SYMPACT
The Cognitive/Emotional Impacts domain consists of 4 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "not at all"/"with no difficulty at all" and value 4 corresponds to "very much"/"extremely"/ "not able at all". The impacts part of the PAH-SYMACT was administered on Day 7 of the symptoms part administration. Items in the impact part have a 7 day recall period. An average Cognitive/Emotional Impacts domain score is determined based on the 4 items in the domain. It was administered two times prior to administration of Macitentan (Visit 2, Baseline) and during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16)."

Secondary Outcome Measures

Full Information

First Posted
March 5, 2014
Last Updated
February 22, 2018
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT02081690
Brief Title
A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain
Acronym
ORCHESTRA
Official Title
A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
October 1, 2015 (Actual)
Study Completion Date
November 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study. Primary objectives: To evaluate the psychometric characteristics of reliability and construct validity of the French, Italian and Spanish versions of the PAH-SYMPACT™. To evaluate the ability of the French, Italian and Spanish versions of the PAH SYMPACT™ to detect change. Secondary objective: To assess the safety of macitentan in patients with pulmonary arterial hypertension (PAH). Exploratory objective: To explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT™) in patients with PAH in France, Italy and Spain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
PAH-SYMPACT, psychometric instrument

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Macitentan
Arm Type
Experimental
Arm Description
Macitentan tablet, dose of 10 mg, once daily
Intervention Type
Drug
Intervention Name(s)
Macitentan
Intervention Description
Macitentan tablet, dose of 10 mg, once daily
Primary Outcome Measure Information:
Title
Evaluation of the Reliability and the Construct Validity of the Cardiopulmonary Symptoms Domain of the PAH-SYMPACT
Description
The Cardiopulmonary Symptoms domain consists of 6 items reported on a 5-point Likert scale (from 0 to 4). The value 0 means "no symptom" and value 4 corresponds to "very severe symptoms".The symptoms part of the PAH-SYMPACT was administered daily over a 7 day period. The recall period of symptom items is the last 24 hours. An average Cardiopulmonary Symptoms domain score is determined based on the daily scores of the 6 items. It was administered two times (daily during 7 days each time) prior to administration of Macitentan (Visit 2, Baseline) and daily during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16).
Time Frame
From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)
Title
Evaluation of the Reliability and the Construct Validity of the Cardiovascular Symptoms Domain of the PAH-SYMPACT
Description
The Cardiovascular Symptoms domain consists of 5 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "no symptoms" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH-SYMPACT was administered daily over a 7 day period. The recall period of symptom items is the last 24 hours. An average Cardiovascular Symptoms domain score is determined based on the daily scores of the 5 items. It was administered two times (daily during 7 days each time) prior to administration of Macitentan (Visit 2, Baseline) and daily during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16).
Time Frame
From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)
Title
Evaluation of the Reliability and the Construct Validity of the Physical Impacts Domain of the PAH-SYMPACT
Description
The Physical Impacts domain consists of 7 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "not at all"/"with no difficulty at all" and value 4 corresponds to "very much"/"extremely"/ "not able at all". The impacts part of the PAH-SYMACT was administered on Day 7 of the symptoms part administration. Items in the impact part have a 7 day recall period. An average Physical Impacts domain score is determined based on the 7 items in the domain. It was administered two times prior to administration of Macitentan (Visit 2, Baseline) and during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16).
Time Frame
From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)
Title
Evaluation of the Reliability and the Construct Validity of the Cognitive/Emotional Impacts Domain of the PAH-SYMPACT
Description
The Cognitive/Emotional Impacts domain consists of 4 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "not at all"/"with no difficulty at all" and value 4 corresponds to "very much"/"extremely"/ "not able at all". The impacts part of the PAH-SYMACT was administered on Day 7 of the symptoms part administration. Items in the impact part have a 7 day recall period. An average Cognitive/Emotional Impacts domain score is determined based on the 4 items in the domain. It was administered two times prior to administration of Macitentan (Visit 2, Baseline) and during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16)."
Time Frame
From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent prior to initiation of any study-mandated procedure. Patients with symptomatic PAH in WHO Functional Class (FC) II or III. Patients with PAH belonging to one of the following subgroups of the Dana Point Clinical Classification Group 1: Idiopathic, or, Heritable, or, Drug or toxin induced, or, Associated with one of the following: i. Connective tissue disease, ii. Congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair, iii. HIV infection. Documented hemodynamic diagnosis of PAH by right heart catheterization - performed at any time prior to Screening showing: Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and, Resting pulmonary vascular resitance (PVR) > 240 dyn.s.cm-5 and, Pulmonary capillary wede pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg. 6-minute walk distance (6MWD) ≥ 150 m at Screening. Able to fluently speak and read the local language. Men or women aged 18-80; women of childbearing potential (as defined below) must: Have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to perform monthly serum pregnancy tests, and, Agree to use two reliable methods of contraception in parallel, from Screening Visit 1 until 1 month after study drug discontinuation (see details below). A female is considered to have childbearing potential unless she meets at least one of the following criteria: Previous bilateral salpingo and/or oophorectomy, or hysterectomy. Premature ovarian failure confirmed by a specialist. Pre-pubescence, XY genotype, Turner syndrome, uterine agenesis. Postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause. Of the two contraceptive methods that must be used, one must be from Group 1, and one must be from Group 2, defined as follows: Group 1: Oral, implantable, transdermal or injectable hormonal contraceptives, intrauterine devices, female sterilization (tubal ligation or non surgical sterilization, e.g., permanent contraception with Essure procedure), or partner's sterilization (vasectomy). If a hormonal contraceptive is chosen from this group, it must be taken for at least 1 month prior to enrollment. Alternatively, if the Essure procedure is chosen as a contraceptive method, a hysterosalpingogram must have been performed to confirm correct location of the microinserts and tubal occlusion (as per manufacturer's recommendations). Group 2: Female or male condoms, diaphragm or cervical cap, any of them in combination with a spermicide. Sexual abstinence, rhythm methods, or contraception by the partner alone are not considered as acceptable methods of contraception for this study. Exclusion Criteria: Known moderate-to-severe obstructive lung disease (i.e., forced expiratory volume in one second [FEV1] < 80 % of predicted, with FEV1 / forced vital capacity [FVC] < 70%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema). Known moderate-to-severe restrictive lung disease (i.e., total lung capacity [TLC] < 60% of predicted value). Hemoglobin < 100g/L at Screening. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 X upper limit of the normal range (ULN) at Screening. Patients undergoing dialysis. Systolic blood pressure (SBP) < 90 mmHg at Screening. Body weight < 40 kg at Screening. Known concomitant life-threatening diseases with a life expectancy of < 12 months. Treatment with ERAs within 3 months prior to Visit 2, or scheduled to receive any of these compounds, other than macitentan, during the trial. Treatment with intravenous or subcutaneous prostacyclin or prostacyclin analogs within 3 months prior to Visit 2, or scheduled to receive any of these compounds during the trial. Treatment with soluble guanylate cyclase stimulator (riociguat) within 3 months prior to Visit 2, or scheduled to receive riociguat during the trial. Patients who changed the dose of or discontinued phosphodiesterase type-5 inhibitor (PDE5i), inhaled prostacyclin analogues, or calcium channel blockers within 3 months prior to Visit 2. Initiation of diuretics within 1 week prior to the Baseline period. Patients on oral diuretics in whom the dose has not been stable for at least 1 week prior to the Baseline period. Treatment with cytochrome P4500 (CYP) 3A inducers within 4 weeks prior to Visit 2. Recently started (< 8 weeks prior to Visit 2) or planned cardio-pulmonary rehabilitation program based on exercise. Females who are lactating or pregnant (positive Screening or Baseline pregnancy test) or plan to become pregnant during the study. Known hypersensitivity to macitentan or its excipients or drugs of the same class. Treatment with another investigational drug within 3 months prior to Visit 2. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc Perchene
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital de Haut Levêque
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpital Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Albert Michallon
City
Grenoble
ZIP/Postal Code
38700
Country
France
Facility Name
CHU de Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Name
CHRU Lille - Hôpital Cardiologique
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Louis Pradel
City
Lyon
ZIP/Postal Code
69677
Country
France
Facility Name
Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpitaux de Brabois
City
Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Hôpital Nord
City
Saint-Etienne
ZIP/Postal Code
42227
Country
France
Facility Name
Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Universita degli Studi di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ospedale di Venere
City
Bari
ZIP/Postal Code
70131
Country
Italy
Facility Name
Ospedale Sant'Orsola
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O.U.C. Careggi
City
Firenze
ZIP/Postal Code
50124
Country
Italy
Facility Name
Milan Sacco Hospital
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
AORN Azienda Ospedaliera dei Colli
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ambulatorio Scompenso Cardiaco e Trapiant
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Istituto di Fisiologia clinica - CNR
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare
City
Roma
ZIP/Postal Code
00186
Country
Italy
Facility Name
UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale "S. Maria di Cà Foncello"
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
Policlinico G.B. Rossi
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Hospital Universitario Insular Gran Canarias
City
Las Palmas de Gran Canaria
State/Province
Islas Canarias
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital General de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Val Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Cruces
City
Bilbao
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Dr Negrin
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital 12 Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Carlos Haya
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Son Espases
City
Palma de Mallorca
ZIP/Postal Code
7010
Country
Spain
Facility Name
Hospital de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospita General U. Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain

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