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

Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH) (Compass-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00303459
First received: March 16, 2006
Last updated: January 22, 2015
Last verified: January 2015
Results First Received: January 2, 2015  
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: Pulmonary Arterial Hypertension
Interventions: Drug: bosentan
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
First subject, first visit was17 May 2006 and last subject, last visit was 05 Dec 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a screening period of up to 14 days to assess eligibility. A total of 377 patients were screened.

Reporting Groups
  Description
Bosentan

Bosentan

bosentan: bosentan/62.5 mg tablet, twice a day (b.i.d.) for 4 weeks then bosentan/125 mg tablet/b.i.d.

Placebo

Placebo

placebo: Matching bosentan placebo/b.i.d.


Participant Flow:   Overall Study
    Bosentan     Placebo  
STARTED     159     175 [1]
COMPLETED     76     86  
NOT COMPLETED     83     89  
Death                 33                 44  
Withdrawal of consent                 32                 26  
Lost to Follow-up                 5                 4  
Administrative reason                 7                 7  
Decision by the investigator                 5                 7  
Lung transplantation                 1                 1  
[1] One subject randomized to placebo did not receive study treatment



  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.
All randomized set

Reporting Groups
  Description
Bosentan

Bosentan

bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.

Placebo

Placebo

placebo: Matching bosentan placebo/b.i.d.

Total Total of all reporting groups

Baseline Measures
    Bosentan     Placebo     Total  
Number of Participants  
[units: participants]
  159     175     334  
Age  
[units: years]
Mean ± Standard Deviation
  52.9  ± 15.44     54.7  ± 15.73     53.9  ± 15.60  
Gender  
[units: participants]
     
Female     125     128     253  
Male     34     47     81  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian/White     147     149     296  
Black     7     12     19  
Hispanic     5     6     11  
Other     0     8     8  
Region of Enrollment  
[units: participants]
     
Brazil     36     35     71  
Czech Republic     12     15     27  
Denmark     3     4     7  
Germany     19     22     41  
Greece     4     5     9  
Portugal     3     0     3  
Saudi Arabia     0     1     1  
Slovakia     4     3     7  
Spain     1     1     2  
Sweden     4     5     9  
United Kingdom     0     1     1  
United States     73     83     156  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to First Confirmed Morbidity/Mortality Event up to the End of Study   [ Time Frame: From baseline to end of study, approximately 86 months ]

2.  Secondary:   Time to First Confirmed Death, Hospitalization for Worsening or Complication of PAH or Initiation of Intravenous Prostanoids, Atrial Septostomy, or Lung Transplantation   [ Time Frame: Baseline to end of study, approximately 86 months ]

3.  Secondary:   Change From Baseline to Week 16 in 6 Minute Walk Test (6MWT)   [ Time Frame: From baseline to week 16 ]

4.  Secondary:   Number of Participants With Improved, No Change, or Worsened World Health Organisation Functional Class From Baseline to Week 16   [ Time Frame: From baseline to Week 16 ]

5.  Secondary:   Time to Death of All Causes From Baseline to End of Study   [ Time Frame: Baseline to End of Study, approximately 86 months ]

6.  Secondary:   Adjusted Percentage Ratio From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-pro-BNP)   [ Time Frame: Baseline to Month 20 ]

7.  Secondary:   Change From Baseline to Week 16 in Borg Dyspnea Index   [ Time Frame: Baseline to Week 16 ]

8.  Secondary:   Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Questionnaire Calculated Score   [ Time Frame: From baseline to Week 16 ]

9.  Secondary:   Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Visual Analogue Scale Score   [ Time Frame: Baseline to Week 16 ]

10.  Secondary:   Patient Global Self Assessment (PGSA) Status at Week 16   [ Time Frame: 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
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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: Jonathan Tolson
Organization: Actelion Pharmaceuticals Ltd
phone: +41 61 565 56 04
e-mail: jonathon.tolson@actelion.com


No publications provided


Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00303459     History of Changes
Other Study ID Numbers: AC-052-414, COMPASS-2
Study First Received: March 16, 2006
Results First Received: January 2, 2015
Last Updated: January 22, 2015
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Brazil: National Health Surveillance Agency