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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01674712 | A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease | PHASE3 | COMPLETED | 575 | — | — | Jun 1, 2012 | Oct 1, 2013 | Dec 11, 2014 | 69 | Argentina, Czechia +5 |
Collection and measurement of blood samples.
Collection and measurement of blood samples.
Collection and measurement of blood samples.
| Arm | Type | Description |
|---|---|---|
| Fenofibrate/simvastatin 145/20 mg | EXPERIMENTAL | - |
| Simvastatin 20 mg | ACTIVE_COMPARATOR | - |
| Fenofibrate 145 mg | ACTIVE_COMPARATOR | - |
| Fenofibrate/simvastatin 145/40 mg | EXPERIMENTAL | - |
| Simvastatin 40 mg | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Fixed Combination of Fenofibrate/simvastatin 145/20 mg | DRUG | Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks |
| Simvastatin 20 mg | DRUG | Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks |
| Fenofibrate 145 mg | DRUG | Fenofibrate, tablet, 145 mg, once daily, 12 weeks |
| Fixed Combination of Fenofibrate/simvastatin 145/40 mg | DRUG | Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks |
| Simvastatin 40 mg | DRUG | simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks |
Inclusion Criteria: 1. Either gender (tentatively 50 percent females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose ...