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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00463606 | A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia | PHASE3 | COMPLETED | 760 | — | — | Apr 1, 2007 | Feb 1, 2008 | Oct 3, 2012 | 168 | United States |
The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.
| Arm | Type | Description |
|---|---|---|
| ABT-335 and Rosuvastatin Calcium | EXPERIMENTAL | ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks |
| ABT-335 | ACTIVE_COMPARATOR | ABT-335 135mg monotherapy administered orally, once daily for 12 weeks |
| Rosuvastatin Calcium | ACTIVE_COMPARATOR | Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| ABT-335 and rosuvastatin calcium | DRUG | ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks |
| ABT-335 | DRUG | ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks |
| rosuvastatin calcium | DRUG | Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks |
Inclusion Criteria * Adult male and female participants who voluntarily sign the informed consent. * Fasting lipid results following greater than 12-hour fasting period: * Triglycerides level greater than or equal to 150 mg/dL, * High-density lipoprotein cholesterol less than 40 mg/dL for male...