Pulmonary Arterial HypertensionPhase 3SYMPHONYextNCT01847014

Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument

A Phase 3 study testing Macitentan in people with Pulmonary Arterial Hypertension, run by Actelion at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. 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: 4 participants
Where: 2 sitesUnited States
Study dates: 1 Sep 2013to 30 Nov 2017
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 any study-mandated procedure.
Patients with PAH who completed study AC-055-401
Women of childbearing potential must:
Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum pregnancy tests.
Agree to use two methods of contraception from Visit 1 until 1 month after study drug discontinuation.

Who cannot join

Patients who prematurely discontinued study drug in study AC-055-401
Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study
Known hypersensitivity to macitentan or its excipients or drugs of the same class

Trial locations and contacts

2 sites in 1 country.

United States2 sites

The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio
Kentuckiana Pulmonary Associates
Louisville, Kentucky

Other trials in United States

About this study

Official title: AC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument

Conditions: Pulmonary Arterial Hypertension
Being tested: Macitentan
Keywords: Pulmonary Arterial Hypertension (PAH), psychometric instrument, PAH-SYMPACT
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
Also called ACT-064992
Macitentan tablet, dose of 10 mg, once daily.

Study groups in NCT01847014
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.

Incident Rate of Adverse Events (AEs).
Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit.
Measured: From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201330 Nov 2017

First posted6 May 2013 (estimated)
Study start1 Sep 2013
Primary completion1 Oct 2015
Study completion30 Nov 2017

Why it stopped: Protocol-defined criterion of macitentan availability achieved.

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: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01847014
Sponsor's protocol ID: AC-055-402
Acronym: SYMPHONYext
Status last verified: Jun 2018
First submitted: 2 May 2013
Last updated: 22 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH

All Pulmonary Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
ClinicalTrials.gov ID: NCT01847014
Acronym / sponsor ID: SYMPHONYext / AC-055-402
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension (PAH), psychometric instrument, PAH-SYMPACT
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Protocol-defined criterion of macitentan availability achieved.
Enrolment: 4 participants (actual)
Lead sponsor: ActelionIndustry (pharma, biotech, devices)
Study start: 1 Sep 2013 (actual)
Primary completion: 1 Oct 2015 (actual)
Study completion: 30 Nov 2017 (actual)
First posted: 6 May 2013 (estimated)
Results: Posted 22 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 (5 listed)

Signed informed consent prior to any study-mandated procedure.
Patients with PAH who completed study AC-055-401
Women of childbearing potential must:
Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum pregnancy tests.
Agree to use two methods of contraception from Visit 1 until 1 month after study drug discontinuation.

Key exclusion criteria (3 listed)

Patients who prematurely discontinued study drug in study AC-055-401
Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study
Known hypersensitivity to macitentan or its excipients or drugs of the same class

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-064992Macitentan tablet, dose of 10 mg, once daily.	Drug	Macitentan

Primary outcome

Incident Rate of Adverse Events (AEs).
Time frame: From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug).
Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit.

Results and safety

Results posted to the registry on 22 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Macitentan	4	4

Primary outcome: Incident Rate of Adverse Events (AEs).

Time frame: From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug).. Count of participants. Unit: Participants

Measure	Macitentan n = 4
Participants with severe intensity AEs	1
Participants with AEs	3

Population analysed: Four participants represent the Extension Analysis Set, who transitioned from completion of SYMPHONY AC-055-401 to this open-label extension clinical trial.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Macitentan	1 of 4 (25%)	3 of 4 (75%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pulmonary Arterial Hypertension

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH

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.

Alain Romero, MD study chair

Actelion Pharmaceuticals US, Inc

Gary Palmer, MD, MBA study chair

Actelion Pharmaceuticals US, Inc.

2 sites in 1 country: 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 2 sites in United States.

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 5 inclusion and 3 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 22 Aug 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?

Incident Rate of Adverse Events (AEs). (time frame: From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01847014.

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 22 Aug 2018.