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

NCT ID: NCT03026933

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

KI1107

Group Type: EXPERIMENTAL

KI1107 4 Capsules, QD

Intervention Type: DRUG

KI1107 4 Capsules

Control

Rosuvastatin calcium

Group Type: ACTIVE_COMPARATOR

Rosuvastatin Calcium 20 MG, QD

Intervention Type: DRUG

Rosuvastatin Calcium 20mg, QD

Interventions

KI1107 4 Capsules, QD

KI1107 4 Capsules

Intervention Type: DRUG

Rosuvastatin Calcium 20 MG, QD

Rosuvastatin Calcium 20mg, QD

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Screening Visit

• Age: 19-80
• High risk for cardiovascular disease according to NCEP APT III
• TG≥130mg/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 dompairng screening visit

Exclusion Criteria

• The patient has histories of acute artery disease within 3 months
• The patient has histories of operation revasculatiation or aneurysm within 6 months
• The patient has histories of Unexplained myaliga or diagnosed myalgia or rhabdomyolysis
• The patient has histories of Effectable disease to the procedrue and clinical trial result

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuhnil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Kim CH, Han KA, Yu J, Lee SH, Jeon HK, Kim SH, Kim SY, Han KH, Won K, Kim DB, Lee KJ, Min K, Byun DW, Lim SW, Ahn CW, Kim S, Hong YJ, Sung J, Hur SH, Hong SJ, Lim HS, Park IB, Kim IJ, Lee H, Kim HS. Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial. Clin Ther. 2018 Jan;40(1):83-94. doi: 10.1016/j.clinthera.2017.11.007. Epub 2017 Dec 7.

Reference Type: DERIVED

PMID: 29223557 (View on PubMed)

Other Identifiers

13-OR-8301

Identifier Type: -

Identifier Source: org_study_id