drugset / Trial / NCT02056847
to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia
Phase 4
Completed
313 enrolled
JW Pharmaceutical
Ajou University School of Medicine · collabAsan Medical Center · collabChonbuk National University Hospital · collabChonnam National University Hospital · collabChungnam National University Hospital · collabDong-A University Hospital · collabEulji University Hospital · collabGangnam Severance Hospital · collabHallym University Medical Center · collabKorea University Guro Hospital · collabKyunghee University Medical Center · collabSamsung Medical Center · collabSeoul National University Bundang Hospital · collabSeoul National University Hospital · collabSeverance Hospital · collabThe Catholic University of Korea · collabUlsan University Hospital · collabYeungnam University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective : To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG). H0: µT-µC ≥ 0.4 vs H1: µT-µC \< 0.4 µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)
Timeline
- Start
- 2013-09
- Primary completion
- 2017-05
- Completion
- 2017-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pitavastatin | Small molecule | 2 mg | — |
| Comparator | Pitavastatin | Small molecule | 4 mg | — |
Indications
No indication recorded.