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

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

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

Study Overview

• Status: Unknown
• Conditions: Hyperlipidemias
• Intervention / Treatment: Drug: HCP1105; Drug: HGP0816; Drug: Placebo of HGP0816; Drug: Placebo of HCP1105

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 Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 139-711
    • Recruiting
    • Euljii General Hospital
    • Contact: Jin-Young Jang; Phone Number: +82-2-970-8216; Email: erica_37@naver.com
    • Principal Investigator: Kyung Ah Han, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental sequence; Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816	Drug: HCP1105; Rosuvastatin + Omega-3-acids ethyl esters; Drug: HGP0816; Rosuvastatin; Drug: Placebo of HGP0816; Exclusion of Rosuvastatin in HGP0816
Placebo Comparator: comparative sequence; Run-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg	Drug: HGP0816; Rosuvastatin; Drug: Placebo of HCP1105; Soybean Oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean rate of change of non-HDL-C (%) from baseline	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean rate of change of HDL-C (%) from baseline		4, 8, 12 weeks
Mean rate of change of LDL-C (%) 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 Total apo A1 (%) 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	target level (Non-HDL-C<130mg/dL)	4, 8, 12 weeks

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Jung-yeol Park, M.D., Ph.D., Asan Medecal Center

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: September 11, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Estimate): September 16, 2015
• Last Update Submitted That Met QC Criteria: September 15, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: HM-ROMA-301