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Trial record 20 of 66 for:    "Lung Disease" | "Bosentan"

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

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ClinicalTrials.gov Identifier: NCT01330108
Recruitment Status : Completed
First Posted : April 6, 2011
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Arterial Hypertension
Intervention Drug: ambrisentan
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ambrisentan
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patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.

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

Period Title: Overall Study
Started 32
Completed 28
Not Completed 4
Reason Not Completed
Withdrawal by Subject             4
Arm/Group Title Ambrisentan
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patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.

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

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
Subjects described in baseline are those that completed the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
52.6  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
26
  92.9%
Male
2
   7.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  17.9%
White
23
  82.1%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Number of Subjects Not Able to Tolerate Ambrisentan
Hide Description If a subject was not able tolerate ambrisentan, subject was returned to use of bosentan and ambrisentan was withdrawn within first 12 weeks of start. A subject was considered to not be able to tolerate ambrisentan if they experienced an adverse event or side effect that was not acceptable to the subject.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ambrisentan
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
4
2.Secondary Outcome
Title Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan
Hide Description Evaluate the change in exercise tolerance. Measured the distance a subject was capable of walking in 6 minutes at basline compared to the distance at 12 weeks. The distance was measured in meters. A postive result reflects the distance increased at 12 weeks, a negative result reflects how much shorter the distance was.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ambrisentan
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 28
Mean (Full Range)
Unit of Measure: meters
368.71
(190 to 510)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ambrisentan
Hide Arm/Group Description

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

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

All-Cause Mortality
Ambrisentan
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ambrisentan
Affected / at Risk (%) # Events
Total   0/32 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ambrisentan
Affected / at Risk (%) # Events
Total   14/32 (43.75%)    
Cardiac disorders   
edema *  10/32 (31.25%)  10
lower extremity edema * [1]  2/32 (6.25%)  2
Skin and subcutaneous tissue disorders   
rash *  1/32 (3.13%)  1
rash, not attibuted to drug *  1/32 (3.13%)  1
*
Indicates events were collected by non-systematic assessment
[1]
resolved post withdrawl of drug
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
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
Layout table for Results Point of Contact information
Name/Title: Robert C Bourge
Organization: University of Alabama at Birmingham
Phone: 205-934-3624
EMail: bbourge@uab.edu
Layout table for additonal information
Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01330108     History of Changes
Other Study ID Numbers: SCOBA-PH
First Submitted: April 4, 2011
First Posted: April 6, 2011
Results First Submitted: January 28, 2014
Results First Posted: August 11, 2014
Last Update Posted: August 11, 2014