Evaluating the Efficacy and Safety of HCP1105 in Combined Hyperlipidemic Patients With High Risk for CHD

Phase 3

• Conditions: Hyperlipidemias
• Interventions: Drug: HCP1105; Drug: HGP0816; Drug: Placebo of HCP1105; Drug: Placebo of HGP0816

• Registration Number: NCT02551172
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

To investigate the efficacy and safety after administration of HCP1105 in hyperlipidemic patients with high risk for CHD.

Detailed Description

An efficacy and safety study of HCP1105 Capsule in combined hyperlipidemic patients with high risk for Coronary Heart Disease(CHD): A randomized,double-blind, multicenter, phase 3 study.

Study Timeline

• Study Start: 2014-10
• Status Verified: 2015-09
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-15
• Last Update Submitted: 2015-09-15
• Study First Posted: 2015-09-16
• Last Update Posted: 2015-09-16
• Primary Completion: 2016-01
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• age 19≤
• Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria

• History of clinically significant hypersensitivity reaction with HMG-CoA reductase inhibitor and Omega-3
• Subject who has active liver disease and severe liver failure(Continuous elevation of AST,ALT level with unspecified cause or AST, ALT level exceeds more than three times of maximum upper range.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental sequence	Placebo of HGP0816	Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816
experimental sequence	HCP1105	Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816
experimental sequence	HGP0816	Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816
comparative sequence	HGP0816	Run-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg
comparative sequence	Placebo of HCP1105	Run-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg

Primary Outcome Measures

Name	Time	Method
Mean rate of change of non-HDL-C (%) from baseline	12 weeks

Secondary Outcome Measures

Name	Time	Method
Mean rate of change of LDL-C (%) from baseline	4, 8, 12 weeks
Mean rate of change of Total apo A1 (%) from baseline	4, 8, 12 weeks
Mean rate of change of Triglyceride (%) from baseline	4, 8, 12 weeks
Mean rate of change of Total cholesterol (%) from baseline	4, 8, 12 weeks
Mean rate of change of HDL-C (%) from baseline	4, 8, 12 weeks
Mean rate of change of Total apo B (%) from baseline	4, 8, 12 weeks
Mean rate of change of Lipoprotein(a) (%) from baseline	4, 8, 12 weeks
Mean rate of change of hs-CRP (%) from baseline	4, 8, 12 weeks
Rate of the subjects who meet the target level of treatment	4, 8, 12 weeks	target level (Non-HDL-C\<130mg/dL)

Trial Locations

Locations (1)

Euljii General Hospital; 🇰🇷 Seoul, Korea, Republic of