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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01632358 | Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients | PHASE1 | COMPLETED | 279 | — | — | Jun 1, 2012 | Dec 1, 2012 | Dec 2, 2013 | 3 | United States, Jordan +1 |
Summary statistics on number of patients with total adverse events, serious adverse events and death will be reported.
| Arm | Type | Description |
|---|---|---|
| TAP311 capsules | EXPERIMENTAL | Patients will receive TAP311 capsule orally once daily for 14 days. |
| Placebo of TAP311 capsules | PLACEBO_COMPARATOR | Matching placebo to TAP311 capsule, once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| TAP311 capsules | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Male and female patients 18 to 80 years (inclusive) of age. * Patients are not treated for dyslipidemia with medications other than HMG-CoA reductase inhibitors (statins) for at least 4 weeks prior to Day 1. Patients should be on stable doses of current medications, if any, fo...