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EUCTR2013-003457-25

Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Data source: WHO (Imported from 02.08.2020)
Changed: 02.08.2020
Disease category:

Health conditions (Data source: WHO)

Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 21.1Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Interventions (Data source: WHO)


Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Current Sponsor code: ACT-064992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria:
Subject with CTEPH having completed the double-blind (DB) AC-055E201 / MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 47
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

Exclusion criteria:
- Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities.
- Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003457-25

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2013-003457-25-BE

Further information on trial

Date trial registered

11.04.2014

Incorporation of the first participant

22.12.2014

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL)

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

Main Objective: - To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects with inoperable CTEPH
- To evaluate the long term effects of macitentan 10 mg on exercise capacity and functional class (FC).;Secondary Objective: Not Applicable;Primary end point(s): Evaluation of the long-term safety and tolerability:
- Treatment-emergent AEs up to 30 days after study drug
discontinuation.
- AEs leading to premature discontinuation of study drug.
- Treatment-emergent SAEs up to 30 days after study drug
discontinuation.
- Treatment-emergent marked laboratory abnormalities up to 30 days
after study drug discontinuation.
- Change in vital signs (blood pressure , heart rate) and body weight
from baseline to all assessed time points during the study;Timepoint(s) of evaluation of this end point: From baseline up to 30 days after study drug discontinuation

Secundary end point (Data source: WHO)

Secondary end point(s): Change from baseline to each scheduled time point in exercise capacity,
as measured by the 6MWD;Timepoint(s) of evaluation of this end point: Baseline up to 30 months

Contact information (Data source: WHO)

Actelion Pharmaceuticals Ltd.

Trial results (Data source: WHO)

Results summary

Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Austria, Belgium, Bulgaria, Canada, Chile, China, Czech Republic, France, Germany, Hungary, Italy, Lithuania, Mexico, Netherlands, Poland, Russian Federation, South Africa, Switzerland, Thailand, Ukraine, United Kingdom, United States

Contact for further information on the trial

Contact for general information (Data source: WHO)

Clinical Trial Disclosure Desk
Gewerbestrasse 16
Actelion Pharmaceuticals Ltd.
clinical-trials-disclosure@its.jnj.com

Contact for scientific information (Data source: WHO)

Clinical Trial Disclosure Desk
Gewerbestrasse 16
Actelion Pharmaceuticals Ltd.
clinical-trials-disclosure@its.jnj.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Actelion Pharmaceuticals Ltd.

Further trial identification numbers

Secondary ID (Data source: WHO)

AC-055E202
2013-003457-25-CZ