Pulmonary Hypertension
Conditions
Brief summary
The primary objective of this study is to monitor the long-term safety of ambrisentan in adult participants with pulmonary hypertension. The available ambrisentan doses for this study are 2.5, 5, or 10 mg administered orally once daily. Investigators will be able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose adjustments is required. Participants receiving other therapies for pulmonary hypertension that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in this study and continue to receive such therapies. Participants enrolled in this study will receive treatment with ambrisentan until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study.
Interventions
DRUGAmbrisentan
Tablet administered orally once daily
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Men and women with pulmonary hypertension who are discontinuing a clinical study of ambrisentan due to study closure by the sponsor. Eligible participants are those participating in countries where ambrisentan is not yet commercially available. Participants participating in countries where ambrisentan is commercially available may be eligible if they do not qualify for treatment per the current prescribing information of that country. Key
Exclusion criteria
* Participants who have discontinued an ambrisentan clinical study for any other reason than sponsor-initiated study closure are not eligible. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan | First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks) |
Countries
Argentina, Australia, Brazil, Canada, Chile, Mexico, Russia, Ukraine, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Argentina, Australia, Brazil, Canada, Chile, Mexico, Russia, Ukraine, and United States. The first participant was screened on 17 November 2008. The last study observation occurred on 11 September 2019.
Pre-assignment details
140 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Ambrisentan Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study. | 140 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 39 |
| Overall Study | Clinical status did not improve | 1 |
| Overall Study | Investigator's discretion | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other, not specified | 4 |
| Overall Study | Withdrawal of Consent | 4 |
Baseline characteristics
| Characteristic | Ambrisentan |
|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 15.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 4 Participants |
| Race/Ethnicity, Customized Race Black or African American | 5 Participants |
| Race/Ethnicity, Customized Race Other | 4 Participants |
| Race/Ethnicity, Customized Race White | 126 Participants |
| Region of Enrollment Argentina | 18 participants |
| Region of Enrollment Australia | 31 participants |
| Region of Enrollment Brazil | 19 participants |
| Region of Enrollment Canada | 2 participants |
| Region of Enrollment Chile | 13 participants |
| Region of Enrollment Mexico | 12 participants |
| Region of Enrollment Russia | 14 participants |
| Region of Enrollment Ukraine | 2 participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 110 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 39 / 140 |
| other Total, other adverse events | 112 / 140 |
| serious Total, serious adverse events | 80 / 140 |
Outcome results
Primary
Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan
Time frame: First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks)
Population: The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ambrisentan | Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan | 90.7 percentage of participants |