Efficacy/Safety of HCP1306 Tablet Versus HGP0816 Tablet in Patients With Primary Hypercholesterolemia

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-04-30

Brief Summary

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The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with primary hypercholesterolemia.

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Detailed Description

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Conditions

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Primary Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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Inclusion Criteria

* Aged over 19 years
* Signed informed consent
* At visit 1, LDL-C ≤ 250mg/dL and Triglyceride \< 400 mg/dL
* After 4 weeks more TLC, At visit2, LDL-C ≤ 250mg/dL, Triglyceride \< 400 mg/dL and satisfied criteria according to Risk of cardiovascular disease

Exclusion Criteria

* Current or past history of hypersensitivity to HMG-CoA reductase inhibitors and component of Ezetimibe
* Has an active liver disease and severe liver disorder (continous elevation of AST, ALT level or exceeds more than 3 times of normal upper limit)
* Has a severe renal failure and kidney injury (Creatinine level exceeds more than 2 times of normal upper limit)
* CK level exceeds more than 5 times of normal upper limit
* Uncontrolled hypertension patient (SBP≥ 180 mmHg or DBP ≥ 110 mmHg)
* Uncontrolled diabetes mellitus patient (HbA1c ≥ 9%)
* Uncontrolled malfunctional thyroidism (or at pre-visit 2, TSH level exceeds more than 1.5 times of normal upper limit)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No