NCT03026933

Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled

A Multi-center, Randomized, Double Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1107 in Patients Whose TG Level is Not Adequately Controlled With Rosuvastatin Calcium Monotherapy While LDL-C is Properly Controlled

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Kuhnil Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To examine variation rate of Non-HDL with KI1107 comparison Rosuvastatin monotherapy.

Detailed description

Study design: Randomly assigned to two groups(KI1107 or Rosuvastatin monotherpy) after 4 weeks run-in period and prescribed KI1107 or Rosuvastatin for 8 weeks.

Conditions

• Dyslipidemias

Interventions

Type	Name	Description
DRUG	KI1107 4 Capsules, QD	KI1107 4 Capsules
DRUG	Rosuvastatin Calcium 20 MG, QD	Rosuvastatin Calcium 20mg, QD

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2017-01-20
• Last updated: 2017-01-20