Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AVE5530 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | oral administration 5 mg breakfast timing |
| 2 | EXPERIMENTAL | oral administration 25 mg breakfast timing |
| 3 | EXPERIMENTAL | oral administration 50 mg breakfast timing |
| 4 | EXPERIMENTAL | oral administration 100 mg breakfast timing |
| 5 | EXPERIMENTAL | oral administration 25 mg dinner timing |
| 6 | PLACEBO_COMPARATOR | oral administration |
| 7 | ACTIVE_COMPARATOR | oral administration 10mg breakfast timing |
| Name | Type | Description |
|---|---|---|
| AVE5530 | DRUG | - |
| placebo | DRUG | - |
| ezetimibe | DRUG | - |
Inclusion Criteria: * Patients with mild to moderate primary hypercholesterolemia with stabilized LDL-C baseline ≥130 mg/dL and ≤ 250 mg/dL (≥ 3.36 mmol/L and ≤ 6.46 mmol/L) * Male aged ≥ 18 years or postmenopausal women at screening Exclusion Criteria: * Presence of any clinically significant en...
AVE5530 is an investigational small molecule being developed for hypercholesterolemia, a condition of high cholesterol levels in the blood. It is intended for patients with mild to moderate hypercholesterolemia. The drug is currently in clinical development and has not been approved by regulatory authorities.
AVE5530 is being developed by Sanofi, a multinational pharmaceutical company. Sanofi's stock is traded under the ticker symbol SNY. The company is conducting clinical trials to evaluate the safety and efficacy of AVE5530 in patients with hypercholesterolemia.
AVE5530 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for use. The Phase 2 trial has been completed, and the drug is being studied for the treatment of hypercholesterolemia.
AVE5530 has one completed Phase 2 clinical trial with the identifier NCT00440154. The study evaluated the safety and efficacy of AVE5530 over 4 weeks in patients with mild to moderate hypercholesterolemia. The trial enrolled 206 participants and was conducted in Chile, Hungary, Mexico, Russia, South Korea, and Turkey.
AVE5530 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The completed clinical trial for AVE5530 was a randomized, double-blind, placebo-controlled study, but the drug has not yet received regulatory approval for the treatment of hypercholesterolemia.