Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-335 and rosuvastatin calcium · 1 trial · 2 indications
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...
ABT-335 is an investigational small molecule being developed for cardiovascular conditions including dyslipidemia, hypercholesterolemia, and renal insufficiency. It has been studied in clinical trials for these indications, though it remains in clinical development and is not approved.
ABT-335 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company has sponsored clinical trials evaluating the drug for dyslipidemia and related conditions.
ABT-335 is in Phase 1 clinical development. While some completed trials were Phase 3, the drug's current development stage is Phase 1, meaning it is still investigational and has not received regulatory approval.
ABT-335 has been studied in completed clinical trials including NCT00463606, a Phase 3 study comparing combination therapy with rosuvastatin to monotherapy in dyslipidemia, and NCT00585143, a Phase 1 pharmacokinetic study in renal impairment. Another Phase 3 trial, NCT00680017, evaluated the drug in chronic kidney disease.
ABT-335 has been studied as part of combination therapy with rosuvastatin calcium in clinical trials for dyslipidemia. The trials evaluated the safety and efficacy of ABT-335 and rosuvastatin together compared to rosuvastatin alone, but ABT-335 itself is a distinct investigational drug.