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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00812955 | Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides | PHASE3 | COMPLETED | 474 | — | — | Nov 1, 2008 | Jun 1, 2009 | Oct 3, 2012 | 129 | United States |
The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups: ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.
| Arm | Type | Description |
|---|---|---|
| A - ABT-143 capsules 5/135 mg | EXPERIMENTAL | ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks |
| B - ABT-143 capsules 10/135 mg | EXPERIMENTAL | ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks |
| C - ABT-143 capsules 20/135 mg | EXPERIMENTAL | ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks |
| D - Simvastatin capsules 40 mg | ACTIVE_COMPARATOR | Simvastatin capsules 40 mg daily for 8 weeks |
| Name | Type | Description |
|---|---|---|
| ABT-143 | DRUG | Once daily for 8 weeks |
| simvastatin | DRUG | Once daily for 8 weeks simvastatin capsules 40 mg |
Inclusion Criteria * Participants with hypercholesterolemia and hypertriglyceridemia. * Participants had the following fasting lipid results following a greater than or equal to 12 hour fasting period (measured at the Screening Visit(s)): * Triglycerides level greater than or equal to 150 millig...