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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This study has been withdrawn prior to enrollment.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 2, 2014
Last verified: September 2014

May 2, 2011
September 2, 2014
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 ]
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 ]
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
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Withdrawn
0
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01346930
AC-055B202
No
Not Provided
Not Provided
Not Provided
Sponsor, Actelion
Actelion
Not Provided
Study Chair: Loic Perchenet, PhD Actelion
Actelion
September 2014

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