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 (ROMANTIC)

Kuhnil Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Dyslipidemias

Treatments: Drug: KI1107 4 Capsules, QD; Drug: Rosuvastatin Calcium 20 MG, QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT03026933

13-OR-8301

Details and patient eligibility

About

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

Full 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.

Enrollment: 215 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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215 participants in 2 patient groups

Treatment

Experimental group

Description:

KI1107

Treatment:

Drug: KI1107 4 Capsules, QD

Control

Active Comparator group

Description:

Rosuvastatin calcium

Treatment:

Drug: Rosuvastatin Calcium 20 MG, QD