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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00491530 | A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia | PHASE3 | COMPLETED | 310 | — | — | Jun 1, 2007 | Nov 1, 2008 | Jan 20, 2012 | 1 | United States |
| NCT00300469 | Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood | PHASE3 | COMPLETED | 613 | — | — | Mar 1, 2006 | - | Jun 3, 2009 | 1 | United States |
All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/incapacity or are life-threatening.
\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100
\[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\] x 100
\[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C\] x 100
| Arm | Type | Description |
|---|---|---|
| ABT-335 + rosuvastatin calcium | EXPERIMENTAL | - |
| ABT-335 + simvastatin | EXPERIMENTAL | - |
| ABT-335 + atorvastatin calcium | EXPERIMENTAL | - |
| A | ACTIVE_COMPARATOR | ABT-335 + 20 mg atorvastatin |
| B | ACTIVE_COMPARATOR | ABT-335 + 40 mg atorvastatin |
| C | PLACEBO_COMPARATOR | ABT-335 monotherapy |
| D | PLACEBO_COMPARATOR | 20 mg atorvastatin monotherapy |
| E | PLACEBO_COMPARATOR | 40 mg atorvastatin monotherapy |
| F | PLACEBO_COMPARATOR | 80 mg atorvastatin monotherapy |
| Name | Type | Description |
|---|---|---|
| ABT-335 | DRUG | Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study |
| rosuvastatin calcium | DRUG | Oral coadministration of rosuvastatin calcium (20 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study |
| simvastatin | DRUG | Oral coadministration of simvastatin (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study |
| atorvastatin calcium | DRUG | Oral coadministration of atorvastatin calcium (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study |
| Atorvastatin | DRUG | Daily, 12 weeks, see Arm Description for dosage information |
| Placebo | DRUG | daily, 12 weeks, see Arm Description for placebo information |
Inclusion Criteria: * Adult male and female subjects who voluntarily sign the informed consent. * Subject has successfully completed the treatment phase of the preceding open-label year 1 study. Exclusion Criteria: * Subject is using or will use investigational medications, except as approved by ...