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Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension (SCOBA-PH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01330108
First received: April 4, 2011
Last updated: July 17, 2014
Last verified: June 2014
Results First Received: January 28, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: ambrisentan

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ambrisentan

patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.

ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage.


Participant Flow:   Overall Study
    Ambrisentan  
STARTED     32  
COMPLETED     28  
NOT COMPLETED     4  
Withdrawal by Subject                 4  



  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.
Subjects described in baseline are those that completed the study

Reporting Groups
  Description
Ambrisentan

patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.

ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage.


Baseline Measures
    Ambrisentan  
Number of Participants  
[units: participants]
  28  
Age  
[units: years]
Mean ± Standard Deviation
  52.6  ± 12.9  
Gender  
[units: participants]
 
Female     26  
Male     2  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     5  
White     23  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     28  



  Outcome Measures
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1.  Primary:   Number of Subjects Not Able to Tolerate Ambrisentan   [ Time Frame: baseline to 12 weeks ]

2.  Secondary:   Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan   [ Time Frame: baseline to 12 weeks ]


  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
There is bias in the study due to the fact that subjects have been proven to tolerate the initial drug in the study (bosentan) and adequate time was not allowed for subjects to be able to tolerate ambisentan


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Robert C Bourge
Organization: University of Alabama at Birmingham
phone: 205-934-3624
e-mail: bbourge@uab.edu


No publications provided


Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01330108     History of Changes
Other Study ID Numbers: SCOBA-PH
Study First Received: April 4, 2011
Results First Received: January 28, 2014
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board