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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00903331




Registration number
NCT00903331
Ethics application status
Date submitted
14/05/2009
Date registered
18/05/2009
Date last updated
17/02/2014

Titles & IDs
Public title
Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study
Scientific title
A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis
Secondary ID [1] 0 0
AC-055B201
Universal Trial Number (UTN)
Trial acronym
MUSIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ACT-064992 (macitentan)
Treatment: Drugs - Placebo

Experimental: ACT-064922 - ACT-064922 tablet (macitentan), 10 mg, once daily

Placebo comparator: Placebo - Matching placebo, once daily


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

Treatment: Drugs: Placebo
matching placebo, once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Forced Vital Capacity (FVC) at Baseline and End of Period 1
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study
Timepoint [1] 0 0
Up to end of study (Up to 24 months)

Eligibility
Key inclusion criteria
1. Signed informed consent.
2. Male or female patients of at least 18 years of age (females of child-bearing potential must use a reliable method of contraception).
3. IPF diagnosis within 3 years prior to randomization, proven according to the American Thoracic Society/European Respiratory Society consensus conference criteria, with surgical lung biopsy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Interstitial lung disease due to conditions other than IPF.
2. Presence of extensive honeycombing on Baseline high-resolution computed tomography (HRCT) scan performed within 3 months prior to randomization.
3. Severe concomitant illness limiting life expectancy (< 1 year).
4. Severe restrictive lung disease: forced vital capacity (FVC) < 50% predicted, or FVC < 1.2 liter.
5. Diffusing capacity of the lung for carbon monoxide (DLCO) < 30% predicted.
6. Residual volume = 120% predicted.
7. Obstructive lung disease: forced expiratory volume in 1 second (FEV1)/FVC) < 0.70.
8. Documented sustained improvement of the patient's IPF condition up to 12 months prior to randomization with or without IPF-specific therapy.
9. Recent pulmonary or upper respiratory tract infection (up to 4 weeks prior to randomization).
10. Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements (e.g., pulmonary function tests).
11. Chronic heart failure with New York Heart Association class III/IV or known left ventricular ejection fraction < 25%.
12. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
13. Estimated creatinine clearance < 30 mL/min.
14. Aspartate aminotransferase (AST) and/or alanine aminotransferase > 1.5 x upper limit of normal.
15. Hemoglobin < 75% of the lower limit of the normal range.
16. Systolic blood pressure < 100 mmHg.
17. Pregnant or breast-feeding.
18. Current drug or alcohol dependence.
19. Chronic treatment with the following drugs (within 4 weeks of randomization):

* Oral corticosteroids (> 20 mg/day of prednisone or equivalent),
* Immunosuppressive or cytotoxic drugs including cyclophosphamide and azathioprine,
* Antifibrotic drugs including pirfenidone, D penicillamine, colchicine, tumor necrosis factor a blockers, imatinib and interferon ?,
* Chronic use of N-acetylcysteine prescribed for IPF (> 600 mg/day).
* Oral anticoagulants prescribed for IPF.
20. Treatment with endothelin receptor antagonists within 4 weeks prior to randomization.
21. Systemic treatment within 4 weeks prior to randomization with cyclosporine A or tacrolimus, everolimus, sirolimus (calcineurin or mammalian target of rapamycin (mTOR) inhibitors).
22. Treatment with Cytochrome P450 3A inducers within 4 weeks prior to randomization.
23. Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.
24. Planned treatment, or treatment with another investigational drug within 4 weeks prior to randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
178
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Prince Charles Hospital Lung Transplant - Chermside
Recruitment hospital [2] 0 0
St. Vincent's Public Hospital - Darlinghurst
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Kansas
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United States of America
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Missouri
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
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Bobigny
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France
State/province [17] 0 0
Bron
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France
State/province [18] 0 0
Lille
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Germany
State/province [19] 0 0
Berlin
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Germany
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Giessen
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Germany
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Immenhausen
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Germany
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Koln
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Germany
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Munchen
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Israel
State/province [24] 0 0
Jerusalem
Country [25] 0 0
Israel
State/province [25] 0 0
Petach Tikvah
Country [26] 0 0
Israel
State/province [26] 0 0
Rehovot
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Israel
State/province [27] 0 0
Tel Aviv
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Israel
State/province [28] 0 0
Tel Hashomer
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Italy
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Milan
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Italy
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Orbassano
Country [31] 0 0
Italy
State/province [31] 0 0
Roma
Country [32] 0 0
Italy
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Trieste
Country [33] 0 0
Slovenia
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Golnik
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South Africa
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Johannesburg
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South Africa
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Pretoria
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Spain
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Barcelona
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Spain
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Madrid
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Sweden
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Stockholm
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Turkey
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Ankara
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Turkey
State/province [40] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Loic Perchenet, Ph.D.
Address 0 0
Actelion
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00903331