Pulmonary HypertensionPhase 2MELODY-1NCT02070991
Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
A Phase 2 study testing Macitentan in people with Pulmonary Hypertension, run by Actelion at 32 sites in 11 countries.
Trial summary
Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Macitentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 32 sitesin 11 countries
- Study dates
- 1 Jul 2014to 1 Nov 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females >=18 years of age
- Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)
- Optimized diuretic therapy
Who cannot join
- Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)
- Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs), Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)
Trial locations and contacts
32 sites in 11 countries.
32 sites in 11 countries
United States6 sites
University of Michigan Internal Medicine Cardiology, Pulmonary Hypertension Program
Ann Arbor, Michigan, 48109
Boston University School of Medicine
Boston, Massachusetts, 02118
The Lindner Clinical Trial Center
Cincinnati, Ohio
Houston Methodist Hospital - Heart Failure/Pulm Hypertension
Houston, Texas
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202
Washington University School of Medicine - Center for Advanced Med
St Louis, Missouri
Czechia4 sites
FN Brno-Bohunice, I. interní kardiologická klinika
Brno
FN Olomouc, 1. Interní klinika - kardiologická
Olomouc
IKEM (Institut klinické a experimentální medicíny, Institute for Clinical and Experimental Medicine)
Prague
Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie
Prague
Germany4 sites
DRK Klinken Berlin Kopenick Klinik für Innere Medizin Kardiologie
Berlin
Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)
Cologne
Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Innere Medizin III Kardiologie und Angiologie
Kiel
Klinikum der Universität München Medizinische Klinik und Poliklinik 1 - Großhadern Schwerpunkt Pneumologie
Munich
Israel4 sites
Carmel Medical Center, Pulmonary Unit
Haifa, 34362
Institute of Pulmonology Hadassah Medical Centre : Ein Karem
Jerusalem, 91120
Kaplan Medical Centre / Pulmonary Institute and Department of Medicine
Rehovot, 76100
The Chaim Sheba Medical Center / The Institute of Pulmonology, Physiology and Exercise
Tel HaShomer, 52621
Spain4 sites
Hospital Vall d´Hebron Servicio de Cardiologia
Barcelona, 08035
Hospital Clinic Servicio de Cardiologia
Barcelona, 08036
Hospital Reina Sofia Servicio de Cardiologia
Córdoba, 14004
Hospital Universitario 12 Octubre Servicio de Cardiología
Madrid, 28041
Austria2 sites
Krankenhaus der Elisabethinen Linz, 2. Interne Abteilung
Linz
Medical University of Vienna and AKH Cardiology
Vienna, A-1090
Belgium2 sites
Hôpital Erasme, Cliniques Universitaires de Bruxelles, Cardiologie
Brussels, 1070
University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie
Leuven, 3000
Italy2 sites
A.O. Universitaria Policlinico S. Orsola-Malpighi - Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale - Unità Operativa di Cardiologia
Bologna, 40138
Ospedali Riuniti Di Trieste
Trieste, 34149
Switzerland2 sites
Universitätsklinik für Kardiologie Schweizer Herz- und Gefässzentrum Bern
Bern
Centre Hospitalier Universitaire Vaudois Service de Cardiologie
Lausanne
About this study
Official title: A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, 12-week Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.
- Conditions
- Pulmonary Hypertension
- Being tested
- Macitentan, Placebo
- Keywords
- pre- and post-capillary pulmonary hypertension, CpcPH
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacitentanDrug
Also called ACT-064992
oral tablet, 10 mg once daily
PlaceboDrug
Also called matching placebo
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Macitentan | Experimental | oral tablet, 10 mg once daily. Receives: Drug: Macitentan |
| Placebo | Placebo comparator | Matching placebo, once daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment
The main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline.
Measured: From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day
Secondary outcomes (7)
NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest
Measured: From randomization up to end of treatment period (Week 12)
PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest
Pulmonary vascular resistance (PVR) was assessed at rest by right heart catheterization (RHC).
Measured: From randomization up to end of treatment period (Week 12)
Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)
Measured: From randomization up to end of treatment period (Week 12)
Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)
Measured: From randomization up to end of treatment period (Week 12)
Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP)
Measured: From randomization up to end of treatment period (Week 12)
Change From Baseline to Week 12 in Cardiac Index (CI)
Measured: From randomization up to end of treatment period (Week 12)
Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG)
Measured: From randomization up to end of treatment period (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study start1 Jul 2014
- Primary completion1 Nov 2015
- Study completion1 Nov 2015
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sébastien Roux, PhD, Study chair, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070991
- Sponsor's protocol ID
- AC-055G201
- Acronym
- MELODY-1
- Status last verified
- Apr 2019
- First submitted
- 21 Feb 2014
- Last updated
- 15 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, 12-week Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
- ClinicalTrials.gov ID
- NCT02070991
- Acronym / sponsor ID
- MELODY-1 / AC-055G201
- Conditions
- Pulmonary Hypertension
- Keywords
- pre- and post-capillary pulmonary hypertension, CpcPH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 1 Nov 2015 (actual)
- Study completion
- 1 Nov 2015 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Posted 15 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macitentan | Experimental | Drug: Macitentanoral tablet, 10 mg once daily. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo, once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and Females >=18 years of age
- Subjects with combined pre-and post-capillary Pulmonary Hypertension (CpcPH) due to left ventricular dysfunction (subset of WHO groups 2.1 and 2.2)
- Optimized diuretic therapy
Key exclusion criteria (2 listed)
- Types of Pulmonary Hypertension other than WHO groups 2.1 and 2.2 (Nice classification)
- Administration of PAH-specific therapy (i.e., Endothelin receptor antagonists (ERAs), Prostanoids, Phosphodiesterase 5 (PDE-5) inhibitors, guanylate cyclase stimulators)
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 |
|---|---|---|
| MacitentanAlso: ACT-064992oral tablet, 10 mg once daily | Drug | Macitentan |
| PlaceboAlso: matching placebomatching placebo | Drug | Placebo |
Primary outcome
Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment
Time frame: From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day
The main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline.
7 secondary outcomes
NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest
Time frame: From randomization up to end of treatment period (Week 12)
PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest
Time frame: From randomization up to end of treatment period (Week 12)
Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)
Time frame: From randomization up to end of treatment period (Week 12)
Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)
Time frame: From randomization up to end of treatment period (Week 12)
Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP)
Time frame: From randomization up to end of treatment period (Week 12)
Change From Baseline to Week 12 in Cardiac Index (CI)
Time frame: From randomization up to end of treatment period (Week 12)
Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG)
Time frame: From randomization up to end of treatment period (Week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- 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.
Sébastien Roux, PhD study chair
Actelion
32 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Macitentan in people with Pulmonary Hypertension, run by Actelion at 32 sites in 11 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Czechia, Germany, Israel, Spain and 6 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 May 2019). 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?
Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment (time frame: From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day). 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 15 May 2019.