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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00777920 | Study of Ambrisentan in Participants With Pulmonary Hypertension | PHASE3 | COMPLETED | 140 | — | — | Nov 17, 2008 | Sep 11, 2019 | Sep 30, 2020 | 46 | United States, Argentina +7 |
| NCT00380068 | Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension | PHASE3 | COMPLETED | 224 | — | — | Aug 1, 2006 | May 1, 2009 | Apr 5, 2012 | 39 | United States, Australia +1 |
| NCT00091598 | ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH) | PHASE3 | COMPLETED | 372 | — | — | Jan 1, 2004 | Feb 1, 2006 | Mar 8, 2010 | 46 | United States, Australia +1 |
| NCT00423592 | Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension | PHASE2 | COMPLETED | 36 | — | — | May 1, 2005 | Mar 1, 2009 | Jun 17, 2013 | - | — |
| NCT00424021 | Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension | PHASE2 | COMPLETED | 54 | — | — | Apr 1, 2003 | Dec 1, 2009 | Jan 27, 2012 | - | — |
The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations \> 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of study drug. Safety analysis set included all participants who received at least 1 dose of study drug.
The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of severe severity (ie, made it impossible to perform routine activities and the subject may have experienced intolerable discomfort or pain) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.
The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of moderate severity (ie, interfered with routine activities and subject may have experienced significant discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.
The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of mild severity (ie, did not interfere with routine activities and the subject may have experienced slight discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.
| Arm | Type | Description |
|---|---|---|
| Ambrisentan | EXPERIMENTAL | Participants will receive ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study. |
| Name | Type | Description |
|---|---|---|
| Ambrisentan | DRUG | Tablet administered orally once daily |
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 i...