Status:
COMPLETED
Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled
Lead Sponsor:
Kuhnil Pharmaceutical Co., Ltd.
Conditions:
Dyslipidemias
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.
Detailed Description
Randomly assigned to two groups (KI1106 or Atorvastatin monotherapy) after 4 weeks run-in period and prescribed KI1106 or Atorvastatin for 8 weeks.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Screening Visit
- Age: 20-80
- High risk for cardiovascular disease according to NCEP APT III
- TG≥300mg/dL and 160mg/dL\>LDL-C≥100mg/dL for subjects who were not taking statins for 4 weeks
- 500mg/dL\>TG≥200mg/dL and LDL-C\<110mg/dL for subjects who were taking statins for 4 weeks
- Baseline Visit
- 500mg/dL\>TG≥200mg/dL
- LDL-C\<110mg/dL
- Reduction of LDL-C comparing screening visit
- Exclusion criteria:
- The patient has histories of acute artery disease within 3 months
- The patient has histories of operation revasculariation or aneurysm within 6 months
- The patient has histories of unexplained myalgia or diagnosed myalgia or rhabdomyolysis
- The patient has histories of effect able disease to the procedure and clinical trial result
Exclusion
Key Trial Info
Start Date :
May 4 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2018
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT03482180
Start Date
May 4 2016
End Date
March 23 2018
Last Update
November 19 2018
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