Trial Outcomes & Findings for Crossover Study From Macitentan or Bosentan Over to Ambrisentan (NCT NCT02885012)
NCT ID: NCT02885012
Last Updated: 2019-04-08
Results Overview
Echocardiography is used to estimate the stroke volume, or the amount of blood ejected from the heart with each beat. An average over three beats is used for the estimate and is reported as ml/beat.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
Baseline and 24 Weeks
Results posted on
2019-04-08
Participant Flow
Participant milestones
| Measure |
Switch to Letairis From Bosentan
Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)
Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
|
Switch to Letairis From Macitentan
Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)
Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Crossover Study From Macitentan or Bosentan Over to Ambrisentan
Baseline characteristics by cohort
| Measure |
Switch to Letairis From Bosentan
n=1 Participants
Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)
Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
|
Switch to Letairis From Macitentan
n=2 Participants
Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)
Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
50.5 years
n=7 Participants
|
51.33 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 WeeksEchocardiography is used to estimate the stroke volume, or the amount of blood ejected from the heart with each beat. An average over three beats is used for the estimate and is reported as ml/beat.
Outcome measures
| Measure |
Switch to Letairis From Bosentan
n=1 Participants
Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)
Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
|
Switch to Letairis From Macitentan
n=2 Participants
Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)
Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
|
|---|---|---|
|
Change in Stroke Volume
|
-2.8 ml/beat
Standard Deviation NA
Only one patient
|
8.7 ml/beat
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksPopulation: Second patient in second arm did not complete questionnaire in week 24
Questionnaire-. The questionnaire is designed to determine how pulmonary hypertension affects the patient's life by asking 10 questions which address breathlessness, fatigue, control, and confidence. emPHasis-10 consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.
Outcome measures
| Measure |
Switch to Letairis From Bosentan
n=1 Participants
Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)
Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
|
Switch to Letairis From Macitentan
n=1 Participants
Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)
Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
|
|---|---|---|
|
Change in EmPHasis-10 Score
|
3 units on a scale
Standard Deviation NA
Only one patient
|
4 units on a scale
Standard Deviation NA
Only one patient
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Neither subject in group 2 completed week 24 assessment for this outcome so we are reporting changes at week 12 compared to baseline.
NT-proBNP Biomarker: BNP is released from cardiac cells in response to increased pressure. The higher the value the worse the disease status.
Outcome measures
| Measure |
Switch to Letairis From Bosentan
n=1 Participants
Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)
Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
|
Switch to Letairis From Macitentan
n=2 Participants
Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)
Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
|
|---|---|---|
|
Disease Status as Measured by Change in Biomarker
|
926 pg/mL
Standard Deviation NA
only one subject
|
-78 pg/mL
Standard Deviation 362
|
Adverse Events
Switch to Letairis From Bosentan
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Switch to Letairis From Macitentan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Switch to Letairis From Bosentan
n=1 participants at risk
Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)
Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
|
Switch to Letairis From Macitentan
n=2 participants at risk
Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)
Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Worsening hypoxemia due to pneumonia treated with a Z-pack
|
100.0%
1/1 • Number of events 1 • 24 Weeks
|
0.00%
0/2 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain and worsening PAH
|
0.00%
0/1 • 24 Weeks
|
0.00%
0/2 • 24 Weeks
|
Additional Information
John Terrill Huggins
Medical University of South Carolina
Phone: (843) 792-2296
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place