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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01346930
Other study ID # AC-055B202
Secondary ID
Status Withdrawn
Phase Phase 2
First received May 2, 2011
Last updated September 2, 2014
Start date July 2011
Est. completion date August 2016

Study information

Verified date September 2014
Source Actelion
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review CommitteeCanada: Health CanadaUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesSlovenia: Agency for Medicinal Products - Ministry of HealthSlovenia: Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteeGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesSouth Africa: Human Research Ethics CommitteeSouth Africa: Medicines Control CouncilTurkey: Ministry of HealthTurkey: Ethics CommitteeIsrael: Ethics CommissionIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ethics CommitteeSpain: Comité Ético de Investigación ClínicaSpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencySweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The MUSIC OL study is an open-label extension study, in which all eligible patients having completed the double-blind AC-055B201/MUSIC study as scheduled receive macitentan 10 mg once daily. The study objective is to assess the long-term safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis (IPF).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Signed informed consent prior to initiation of any study-related procedure.

- Patients with IPF and having completed the double-blind AC-055B201/MUSIC study as scheduled, i.e., having remained in the study until the sponsor-declared end-of-study (EOS), whether or not study treatment was prematurely discontinued.

- Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.

Exclusion Criteria:

- Any major violation of protocol AC-055B201/MUSIC.

- Premature discontinuation of study treatment during the AC-055B201/MUSIC study due to an adverse event (AE) assessed as related to the use of macitentan, excluding events of IPF worsening.

- Pregnancy or breast-feeding.

- AST and/or ALT > 3 times the upper limit of the normal range.

- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.

- Known hypersensitivity to drugs of the same class as macitentan, or any of the excipients.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Macitentan
10 mg, tablet, once daily

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Actelion

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events leading to premature discontinuation of study drug 5 years Yes
Secondary Treatment-emergent Severe Adverse Events & occurrence of AST and/or ALT > 3 times the upper limit of the normal range up to 28 days after study drug discontinuation 5 years Yes
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