Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01808313 | Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH) | PHASE3 | COMPLETED | 134 | — | — | Dec 1, 2012 | Aug 15, 2014 | Jun 6, 2017 | 12 | China |
The 6MWT measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Baseline 6MWT comprised of an average of the last two consecutive measurements prior to dosing that varied by not greater than 10 percent (%). If only one measurement was available, that measurement was used as the Baseline value. The last observation carried forward method was used to impute missing values.
| Arm | Type | Description |
|---|---|---|
| ambrisentan | EXPERIMENTAL | ambrisentan 5 mg will be administered to eligible subjects for 12 weeks |
| Name | Type | Description |
|---|---|---|
| ambrisentan | DRUG | Ambrisentan 5 mg will be administered to eligible subjects for 12 weeks |
Inclusion Criteria: * Signed written informed consent prior to beginning study-related procedures. * Subject must be between 18-75 years of age, inclusive, at the Screening Visit. * Subjects must weight ≥40 kg at the Screening Visit. * Subjects must have symptomatic or severe PAH (WHO functional cl...