Pulmonary Arterial HypertensionPhase 3ORCHESTRANCT02081690
A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain
A Phase 3 study testing Macitentan in people with Pulmonary Arterial Hypertension, run by Actelion at 39 sites in 3 countries.
Trial 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™. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Macitentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 39 sitesin 3 countries
- Study dates
- 1 Mar 2014to 1 Nov 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 26Show fewer
- Associated with one of the following:
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
39 sites in 3 countries.
39 sites in 3 countries
Spain14 sites
Hospital General de Alicante
Alicante, 03010
Hospital Val Hebron
Barcelona, 08035
Hospital Clinic
Barcelona, 08036
Hospital de Cruces
Bilbao, 48903
Hospital Reina Sofia
Córdoba, 14004
Hospital Universitario Insular Gran Canarias
Las Palmas de Gran Canaria, Canary Islands, 35016
Hospital Dr Negrin
Las Palmas de Gran Canaria, 35010
Hospital 12 Octubre
Madrid, 28041
Hospital La Paz
Madrid, 28046
Hospital Carlos Haya
Málaga, 29010
Hospital Son Espases
Palma de Mallorca, 7010
Hospital de Valdecilla
Santander, 39008
Hospital Virgen del Rocio
Seville, 41013
Hospita General U. Valencia
Valencia, 46014
France13 sites
Hôpital de Haut Levêque
Bordeaux, 33604
Hôpital Côte de Nacre
Caen, 14033
Hôpital Albert Michallon
Grenoble, 38700
CHU de Bicêtre
Le Kremlin-Bicêtre, 94270
CHRU Lille - Hôpital Cardiologique
Lille, 59037
Hôpital Louis Pradel
Lyon, 69677
Hôpital Arnaud de Villeneuve
Montpellier, 34295
Hôpitaux de Brabois
Nancy, 54511
Hôpital Pontchaillou
Rennes, 35033
Hôpital Charles Nicolle
Rouen, 76031
Hôpital Nord
Saint-Etienne, 42227
Hôpital Civil
Strasbourg, 67091
Hôpital Larrey
Toulouse, 31059
Italy12 sites
Universita degli Studi di Bari
Bari, 70124
Ospedale di Venere
Bari, 70131
Ospedale Sant'Orsola
Bologna, 40138
A.O.U.C. Careggi
Florence, 50124
Milan Sacco Hospital
Milan, 20157
AORN Azienda Ospedaliera dei Colli
Naples, 80131
Ambulatorio Scompenso Cardiaco e Trapiant
Pavia, 27100
Istituto di Fisiologia clinica - CNR
Pisa, 56126
Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare
Roma, 00186
UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica
Rome, 00161
Ospedale "S. Maria di Cà Foncello"
Treviso, 31100
Policlinico G.B. Rossi
Verona, 37134
About this study
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™
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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Macitentan
- Keywords
- PAH-SYMPACT, psychometric instrument
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacitentanDrug
Macitentan tablet, dose of 10 mg, once daily
| Study group | Role | What they receive |
|---|---|---|
| Macitentan | Experimental | Macitentan tablet, dose of 10 mg, once daily Receives: Drug: Macitentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (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).
Measured: From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (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).
Measured: From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (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)."
Measured: From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study start1 Mar 2014
- Primary completion1 Oct 2015
- Study completion1 Nov 2015
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Loïc Perchene, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081690
- Sponsor's protocol ID
- AC-055-310
- Acronym
- ORCHESTRA
- Status last verified
- Feb 2018
- First submitted
- 5 Mar 2014
- Last updated
- 21 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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™
- ClinicalTrials.gov ID
- NCT02081690
- Acronym / sponsor ID
- ORCHESTRA / AC-055-310
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- PAH-SYMPACT, psychometric instrument
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 160 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Nov 2015 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Posted 5 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Macitentan | Experimental | Drug: MacitentanMacitentan tablet, dose of 10 mg, once daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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:
- Documented hemodynamic diagnosis of PAH by right heart catheterization - performed at any time prior to Screening showing:
- 6-minute walk distance (6MWD) ≥ 150 m at Screening.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MacitentanMacitentan tablet, dose of 10 mg, once daily | Drug | Macitentan |
Primary outcome
Evaluation of the Reliability and the Construct Validity of the Cardiopulmonary Symptoms Domain of the PAH-SYMPACT
Time frame: From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)
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
Time frame: From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)
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
Time frame: From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)
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
Time frame: From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)
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)."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loïc Perchene study director
Actelion
39 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Macitentan in people with Pulmonary Arterial Hypertension, run by Actelion at 39 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Spain, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the Reliability and the Construct Validity of the Cardiopulmonary Symptoms Domain of the PAH-SYMPACT (time frame: From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.