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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00907998 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180 | PHASE1 | COMPLETED | 104 | — | — | Jun 1, 2009 | - | Nov 20, 2009 | 11 | United States, Denmark +3 |
| NCT00568594 | Safety and Efficacy of APL180 in Healthy Volunteers and Patients With Coronary Heart Disease (CHD) | PHASE1 | COMPLETED | 176 | — | — | Nov 1, 2007 | - | Dec 24, 2020 | 11 | United States, Belgium +5 |
| Arm | Type | Description |
|---|---|---|
| APL180 (first dose level) | EXPERIMENTAL | - |
| APL180 (second dose level) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| APL180 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Male and female CHD or CHD equivalent patients * Body mass index (BMI) must be within the range of 20 to 35 kg/m2, * Patient must have been on a stable statin therapy for \>8 weeks prior to first dose except for the statin intolerant patients. Exclusion criteria: * Pregnancy...