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Trial Outcomes & Findings for Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension (NCT NCT01330108)

NCT ID: NCT01330108

Last Updated: 2014-08-11

Results Overview

If a subject was not able tolerate ambrisentan, subject was returned to use of bosentan and ambrisentan was withdrawn within first 12 weeks of start.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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

baseline to 12 weeks

Results posted on

2014-08-11

Participant Flow

Participant milestones

Participant milestones
Measure
Ambrisentan
patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension. ambrisentan: ambrisentan 2.5mg, 5mg, \& 10mg. Daily dosage.
Overall Study
STARTED
32
Overall Study
COMPLETED
28
Overall Study
NOT COMPLETED
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Ambrisentan
patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension. ambrisentan: ambrisentan 2.5mg, 5mg, \& 10mg. Daily dosage.
Overall Study
Withdrawal by Subject
4

Baseline Characteristics

Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ambrisentan
n=28 Participants
patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension. ambrisentan: ambrisentan 2.5mg, 5mg, \& 10mg. Daily dosage.
Age, Continuous
52.6 years
STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male
Female
26 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=5 Participants
Race (NIH/OMB)
White
23 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
28 participants
n=5 Participants

PRIMARY outcome

Timeframe: baseline to 12 weeks

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.

Outcome measures

Outcome measures
Measure
Ambrisentan
n=28 Participants
patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension. ambrisentan: ambrisentan 2.5mg, 5mg, \& 10mg. Daily dosage.
Number of Subjects Not Able to Tolerate Ambrisentan
4 participants

SECONDARY outcome

Timeframe: baseline to 12 weeks

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.

Outcome measures

Outcome measures
Measure
Ambrisentan
n=28 Participants
patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension. ambrisentan: ambrisentan 2.5mg, 5mg, \& 10mg. Daily dosage.
Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan
368.71 meters
Interval 190.0 to 510.0

Adverse Events

Ambrisentan

Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Ambrisentan
n=32 participants at risk
patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension. ambrisentan: ambrisentan 2.5mg, 5mg, \& 10mg. Daily dosage.
Cardiac disorders
edema
31.2%
10/32 • Number of events 10
Skin and subcutaneous tissue disorders
rash
3.1%
1/32 • Number of events 1
Skin and subcutaneous tissue disorders
rash, not attibuted to drug
3.1%
1/32 • Number of events 1
Cardiac disorders
lower extremity edema
6.2%
2/32 • Number of events 2

Additional Information

Robert C Bourge

University of Alabama at Birmingham

Phone: 205-934-3624

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place