Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study (MUSIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00903331
First received: May 14, 2009
Last updated: January 2, 2014
Last verified: January 2014
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Interventions: Drug: ACT-064992 (macitentan)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 48 centers in Australia, Canada, France, Germany, Israel, Italy, Slovenia, South Africa, Spain, Sweden, Turkey, and the USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study included a screening period of up to 28 days followed by a double-blind treatment phase that was further divided into two periods. 300 patients were screened and 178 randomized in a 2:1 ratio to study treatment with ACT-064922 or placebo

Reporting Groups
  Description
Placebo

Matching placebo, once daily

Placebo : matching placebo, once daily

ACT-064922

ACT-064922 tablet, 10 mg, once daily

ACT-064992 (macitentan) : tablet, 10 mg, once daily


Participant Flow:   Overall Study
    Placebo     ACT-064922  
STARTED     59     119  
COMPLETED     54     101  
NOT COMPLETED     5     18  
Death                 4                 8  
Withdrawal of consent                 1                 8  
Lung transplant                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

Matching placebo, once daily

Placebo : matching placebo, once daily

ACT-064922

ACT-064922 tablet, 10 mg, once daily

ACT-064992 (macitentan) : tablet, 10 mg, once daily

Total Total of all reporting groups

Baseline Measures
    Placebo     ACT-064922     Total  
Number of Participants  
[units: participants]
  59     119     178  
Age  
[units: years]
Mean ± Standard Deviation
  64.5  ± 6.32     65.1  ± 7.85     64.9  ± 7.37  
Gender  
[units: participants]
     
Female     22     35     57  
Male     37     84     121  
Region of Enrollment  
[units: participants]
     
Australia     9     18     27  
Canada     5     10     15  
France     10     16     26  
Germany     5     8     13  
Israel     2     5     7  
Italy     1     7     8  
Slovenia     1     1     2  
South Africa     1     1     2  
Spain     4     7     11  
Sweden     0     1     1  
Turkey     3     8     11  
United States     18     37     55  



  Outcome Measures
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1.  Primary:   Forced Vital Capacity (FVC) at Baseline and End of Period 1   [ Time Frame: 12 months ]

2.  Secondary:   Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study   [ Time Frame: Up to end of study (Up to 24 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Parisa Danaietash
Organization: Actelion Pharmaceuticals Ltd
e-mail: parisa.danaietash@actelion.com


No publications provided by Actelion

Publications automatically indexed to this study:

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00903331     History of Changes
Other Study ID Numbers: AC-055B201
Study First Received: May 14, 2009
Results First Received: October 29, 2013
Last Updated: January 2, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada
United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee of Protection of Individuals SUD-EST IV (Lyon)
Slovenia: Agency for Medicinal Products - Ministry of Health
Slovenia: Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: District Research Governance
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
Turkey: Ethics Committee
Turkey: Ministry of Health
Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board