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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00440154 | A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate Hypercholesterolemia | PHASE2 | COMPLETED | 206 | — | — | Feb 1, 2007 | Oct 1, 2007 | Dec 16, 2008 | 6 | Chile, Hungary +4 |
| 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...