Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-335 · 5 trials · 7 indications
\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100
\[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\] x 100
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
\[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C\] x 100
| Arm | Type | Description |
|---|---|---|
| ABT-335 + atorvastatin + ezetimibe | ACTIVE_COMPARATOR | - |
| Placebo + atorvastatin + ezetimibe | PLACEBO_COMPARATOR | - |
| 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 | 135 mg capsule, daily, 12 weeks |
| placebo | DRUG | placebo capsule, daily, 12 weeks |
| atorvastatin | DRUG | 40 mg, tablet, daily, 12 weeks |
| ezetimibe | DRUG | 10 mg capsule, daily, 12 weeks |
| 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 |
Inclusion Criteria: * Subjects with mixed dyslipidemia (trigylcerides, \> or = to 150 mg/dL to \< 400 mg/dL; HDL-C \< 40 mg/dL for males, \< 50 mg/dL for females; LDL-C, \> or = to 130 mg/dL). * Subjects must agree to use adequate birth control methods and to adhere to the American Heart Associatio...
ABT-335 is an investigational small molecule being developed for cardiovascular conditions, specifically for mixed dyslipidemia and other dyslipidemias. It has been studied in combination with statin therapies such as atorvastatin and rosuvastatin in patients with multiple abnormal lipid levels in the blood.
ABT-335 is being developed by Abbott Laboratories, a company traded under the ticker symbol ABT. The drug is currently in clinical development for the treatment of dyslipidemias, including mixed dyslipidemia.
ABT-335 has completed Phase 3 clinical trials for mixed dyslipidemia and dyslipidemia. It is an investigational drug and has not been reported as FDA approved. All four completed trials were randomized, double-blind, and placebo-controlled.
ABT-335 has been studied in four completed clinical trials, including NCT00300469, NCT00300482, NCT00491530, and NCT00728910. These trials evaluated the drug in combination with statins for mixed dyslipidemia and included a safety extension study.
ABT-335 is a small molecule developed for cardiovascular conditions. Its specific molecular target has not been disclosed in the available information, so its precise mechanism of action is not described here.