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

Hanmi Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Hyperlipidemias

Treatments: Drug: Placebo of HGP0816; Drug: Placebo of HCP1105; Drug: HGP0816; Drug: HCP1105

Study type: Interventional

Funder types: Industry

Identifiers

NCT02551172

HM-ROMA-301

Details and patient eligibility

About

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

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 2 patient groups, including a placebo group

experimental sequence

Experimental group

Description:

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

Treatment:

Drug: HCP1105

Drug: HGP0816

Drug: Placebo of HGP0816

comparative sequence

Placebo Comparator group

Description:

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

Treatment:

Drug: HGP0816

Drug: Placebo of HCP1105