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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)

Datenbasis: WHO (Import vom 03.05.2024)
Geändert: 02.10.2022, 22:22
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 19.0Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Interventions (Datenquelle: 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 (Datenquelle: 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.

Weitere Angaben zur Studie im WHO-Primärregister

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

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2013-003457-25
Weitere Informationen zur Studie

Datum der Studienregistrierung

06.05.2014

Einschluss der ersten teilnehmenden Person

03.07.2014

Rekrutierungsstatus

Not Recruiting

Wissenschaftlicher Titel (Datenquelle: 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)

Studientyp (Datenquelle: WHO)

Interventional clinical trial of medicinal product

Design der Studie (Datenquelle: 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 (Datenquelle: WHO)

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

Primäre Endpunkte (Datenquelle: 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 discontinuationpplicable

Sekundäre Endpunkte (Datenquelle: 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

Kontakt für Auskünfte (Datenquelle: WHO)

Actelion Pharmaceuticals Ltd.

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

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 zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

noch keine Angaben verfügbar

Studiendurchführungsorte

Durchführungsländer (Datenquelle: 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

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

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

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

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

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

AC-055E202
2013-003457-25-CZ
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