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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00680017 | 30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease | PHASE3 | COMPLETED | 280 | — | — | Jun 1, 2008 | Apr 1, 2011 | Oct 3, 2012 | 114 | United States, Puerto Rico |
Triglycerides were measured in milligrams/deciliter.
| Arm | Type | Description |
|---|---|---|
| ABT-335 plus rosuvastatin | EXPERIMENTAL | ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks |
| Rosuvastatin | ACTIVE_COMPARATOR | Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks |
| Name | Type | Description |
|---|---|---|
| ABT-335 plus rosuvastatin | DRUG | ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks |
| Rosuvastatin | DRUG | Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks |
Inclusion Criteria * Dyslipidemic participants with Chronic Kidney Disease Stage 3 * For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit\[s\]): * Estimated glomerular filtration rate between 30 and 59 mL/min/1...