Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1036 for:    DUAL-2
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Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients (DUAL-2)

This study has been terminated.
(company decision)
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01474122
First received: October 31, 2011
Last updated: January 19, 2015
Last verified: January 2015
Results First Received: January 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Systemic Sclerosis
Ulcers
Interventions: Drug: macitentan 3mg
Drug: macitentan 10mg
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
Conducted at 73 centers in 20 countries.The first patient randomized was 9 Feb 2012 and last patient, last visit was 6 Feb 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A screening visit was performed between Day −14 and Day −1 of the study. Of the 324 patients screened for the study, 59 were screen failures.

Reporting Groups
  Description
Macitentan 3mg

macitentan tablet 3mg once daily

macitentan 3mg: macitentan tablet 3mg once daily

Macitentan 10mg

macitentan tablet 10mg once daily

macitentan 10mg: macitentan tablet 10mg once daily

Placebo

matching placebo once daily

placebo: matching placebo once daily


Participant Flow for 2 periods

Period 1:   Period 1: Baseline to Week 16
    Macitentan 3mg     Macitentan 10mg     Placebo  
STARTED     88     88 [1]   89  
COMPLETED     87     86     88  
NOT COMPLETED     1     2     1  
[1] One patient was randomised but did not receive study treatment

Period 2:   Period 2: Week 16 to End of Study
    Macitentan 3mg     Macitentan 10mg     Placebo  
STARTED     87     86     88  
COMPLETED     70 [1]   73 [1]   73 [1]
NOT COMPLETED     17     13     15  
[1] Patients on treatment at the time of study termination



  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.
Full analysis set

Reporting Groups
  Description
Macitentan 3mg

macitentan tablet 3mg once daily

macitentan 3mg: macitentan tablet 3mg once daily

Macitentan 10mg

macitentan tablet 10mg once daily

macitentan 10mg: macitentan tablet 10mg once daily

Placebo

matching placebo once daily

placebo: matching placebo once daily

Total Total of all reporting groups

Baseline Measures
    Macitentan 3mg     Macitentan 10mg     Placebo     Total  
Number of Participants  
[units: participants]
  88     88     89     265  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     76     83     75     234  
>=65 years     12     5     14     31  
Age  
[units: years]
Mean ± Standard Deviation
  50.6  ± 13.20     47.4  ± 13.02     50.6  ± 12.88     49.6  ± 13.06  
Gender  
[units: participants]
       
Female     75     71     71     217  
Male     13     17     18     48  
Race/Ethnicity, Customized  
[units: participants]
       
White     62     63     68     193  
Black or African American     2     0     0     2  
Asian     6     4     6     16  
Hispanic     12     14     9     35  
Other     6     7     6     19  
Region of Enrollment  
[units: participants]
       
Argentina     12     3     3     18  
Belgium     0     1     0     1  
China     3     3     5     11  
Colombia     3     5     6     14  
Germany     2     3     2     7  
Greece     2     4     5     11  
Ireland     1     2     1     4  
Israel     5     7     12     24  
Mexico     6     9     6     21  
Netherlands     3     2     1     6  
New Zealand     2     1     3     6  
Poland     7     11     5     23  
Portugal     1     2     4     7  
Puerto Rico     1     1     0     2  
Russian Federation     5     4     7     16  
South Africa     3     4     2     9  
Turkey     0     0     1     1  
Ukraine     9     7     4     20  
United Kingdom     7     3     6     16  
United States     16     16     16     48  



  Outcome Measures
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1.  Primary:   Incidence Rate of New Digital Ulcers (DUs) up to Week 16   [ Time Frame: Baseline to Week 16 ]

2.  Secondary:   Percentage of Participants Without a New DU Up To Week 16   [ Time Frame: Baseline to Week 16 ]

3.  Secondary:   Percentage of Participants With at Least One DU Complication   [ Time Frame: Up to 95 weeks ]

4.  Secondary:   Change in Hand Functionality Health Assessment Questionnaire – Disability Index (HAQ-DI) Hand Component From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]

5.  Secondary:   Health Assessment Questionnaire – Disability Index (HAQ-DI) Overall Score From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]

6.  Secondary:   Change in Hand Functionality - Hand Disability in Systemic Sclerosis – Digital Ulcers (HDISS-DU) Score From Baseline to Week 16   [ Time Frame: Baseline to Week 16 ]


  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
No text entered.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Angelina Marr
Organization: Actelion Pharmaceuticals Ltd
phone: +41 61 565 63 69
e-mail: angelina.marr@actelion.com


No publications provided


Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01474122     History of Changes
Other Study ID Numbers: AC-055C302
Study First Received: October 31, 2011
Results First Received: January 19, 2015
Last Updated: January 19, 2015
Health Authority: United States: Food and Drug Administration