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

Dyslipidemias Clinical Trial

— ROMANTIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026933
• Other study ID #: 13-OR-8301
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2017
• Last updated: January 19, 2017
• Start date: May 2014
• Est. completion date: March 2016

Study information

• Verified date: January 2017
• Source: Kuhnil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• KI1107 4 Capsules, QD
KI1107 4 Capsules
• Rosuvastatin Calcium 20 MG, QD
Rosuvastatin Calcium 20mg, QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kuhnil Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation rate of Non HDL-C		8 weeks
Secondary	Variation rate of TG		4 weeks, 8 weeks
Secondary	Variation rate of Non HDL-C		4 weeks
Secondary	Variation rate of TC		4 weeks, 8 weeks
Secondary	Variation rate of LDL-C		4 weeks, 8 weeks
Secondary	Variation rate of VLDL-C		4 weeks, 8 weeks
Secondary	Variation rate of Apo A-I		4 weeks, 8 weeks
Secondary	Variation rate of Apo B		4 weeks, 8 weeks