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

Hanmi Pharmaceutical Company Limited270 enrolled

Overview

To investigate the efficacy and safety after administration of HCP1105 in 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

270

Conditions

Hyperlipidemias

Interventions

HCP1105DRUG

Rosuvastatin + Omega-3-acids ethyl esters

HGP0816DRUG

Rosuvastatin

Placebo of HCP1105DRUG

Soybean Oil

Placebo of HGP0816

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Euljii General Hospital

Seoul, Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Mean rate of change of non-HDL-C (%) from baseline

Time frame: 12 weeks

Secondary Outcomes

Mean rate of change of HDL-C (%) from baseline

Time frame: 4, 8, 12 weeks

Mean rate of change of LDL-C (%) from baseline

Time frame: 4, 8, 12 weeks

Mean rate of change of Triglyceride (%) from baseline

Time frame: 4, 8, 12 weeks

Mean rate of change of Total cholesterol (%) from baseline

Time frame: 4, 8, 12 weeks

Mean rate of change of Total apo A1 (%) from baseline

Time frame: 4, 8, 12 weeks

Mean rate of change of Total apo B (%) from baseline

Time frame: 4, 8, 12 weeks

Mean rate of change of Lipoprotein(a) (%) from baseline

Time frame: 4, 8, 12 weeks

Mean rate of change of hs-CRP (%) from baseline

Time frame: 4, 8, 12 weeks

Rate of the subjects who meet the target level of treatment

target level (Non-HDL-C\<130mg/dL)

Time frame: 4, 8, 12 weeks

Central Contacts

Chang-Hee Jung

CONTACT

02-3010-3246 chjung0204@gmail.com

Data from ClinicalTrials.gov

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