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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-02-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hyperlipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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experimental sequence

Run-in period → Treatment period HGP0816 20mg 1tab HCP1105 4capsues +Placebo of HGP0816

Group Type EXPERIMENTAL

HCP1105

Intervention Type DRUG

Rosuvastatin + Omega-3-acids ethyl esters

HGP0816

Intervention Type DRUG

Rosuvastatin

Placebo of HGP0816

Intervention Type DRUG

Exclusion of Rosuvastatin in HGP0816

comparative sequence

Run-in period → Treatment period HGP0816 20mg 1tab Placebo of HCP1105 4capsues +HGP0816 20mg

Group Type PLACEBO_COMPARATOR

HGP0816

Intervention Type DRUG

Rosuvastatin

Placebo of HCP1105

Intervention Type DRUG

Soybean Oil

Interventions

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HCP1105

Rosuvastatin + Omega-3-acids ethyl esters

Intervention Type DRUG

HGP0816

Rosuvastatin

Intervention Type DRUG

Placebo of HCP1105

Soybean Oil

Intervention Type DRUG

Placebo of HGP0816

Exclusion of Rosuvastatin in HGP0816

Intervention Type DRUG

Eligibility Criteria

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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.)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No