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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)

Base di dati: WHO (Importata da 03.05.2024)
Cambiato: 2 ott 2022, 22:22
Categoria di malattie:

Health conditions (Fonte di dati: 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 (Fonte di dati: 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 (Fonte di dati: 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.

Altri dati sulla sperimentazione nel registro primario dell’OMS

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

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2013-003457-25
Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

6 mag 2014

Inserimento del primo partecipante

3 lug 2014

Stato di reclutamento

Not Recruiting

Titolo scientifico (Fonte di dati: 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)

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional clinical trial of medicinal product

Disegno della sperimentazione (Fonte di dati: 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

Fase (Fonte di dati: WHO)

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

Punti finali primari (Fonte di dati: 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

Punti finali secondari (Fonte di dati: 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

Contatto per informazioni (Fonte di dati: WHO)

Actelion Pharmaceuticals Ltd.

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

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)

Collegamento ai risultati nel registro primario

ancora nessuna informazione disponibile

Informazioni sulla disponibilità dei dati dei singoli partecipanti

ancora nessuna informazione disponibile

Siti di esecuzione della sperimentazione

Paesi di esecuzione (Fonte di dati: 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

Contatto per maggiori informazioni sulla sperimentazione

Contatto per informazioni generali (Fonte di dati: WHO)

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

Contatto per informazioni scientifiche (Fonte di dati: WHO)

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

Altri numeri di identificazione delle sperimentazioni

Secondary ID (Fonte di dati: WHO)

AC-055E202
2013-003457-25-CZ
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