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Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis (MUSIC OL)

This study has been withdrawn prior to enrollment.
(Due to Protocol AC-055B201 (MUSIC) not meeting it's primary end point)
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT01346930
First received: May 2, 2011
Last updated: September 12, 2011
Last verified: September 2011
History of Changes

May 2, 2011
September 12, 2011
July 2011
August 2016   (final data collection date for primary outcome measure)
Adverse Events leading to premature discontinuation of study drug [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01346930 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
Long Term, Single-arm, Open-label Extension Study of the MUSIC Study to Assess the Safety and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis

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).
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
Drug: Macitentan
10 mg, tablet, once daily
Experimental: Macitentan
Macitentan tablet, 10 mg, once daily
Intervention: Drug: Macitentan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
178
August 2016
August 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01346930
AC-055B202
No
Sponsor, Actelion
Actelion
Not Provided
Study Chair: Loic Perchenet, PhD Actelion
Actelion
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP