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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Primary Hypercholesterolemia

Treatments: Drug: HGP0816 10mg; Drug: HCP1306 10/10mg; Drug: HCP1306 5/10mg; Drug: HGP0816 20mg; Drug: HCP1306 20/10mg; Drug: HGP0816 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02205606

HM-ROZE-301

Details and patient eligibility

About

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

Enrollment: 412 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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412 participants in 6 patient groups

HGP0816 5mg

Active Comparator group

Treatment:

Drug: HGP0816 5mg

HGP0816 10mg

Active Comparator group

Treatment:

Drug: HGP0816 10mg

HGP0816 20mg

Active Comparator group

Treatment:

Drug: HGP0816 20mg

HCP1306 5/10mg

Experimental group

Treatment:

Drug: HCP1306 5/10mg

HCP1306 10/10mg

Experimental group

Treatment:

Drug: HCP1306 10/10mg

HCP1306 20/10mg

Experimental group

Treatment:

Drug: HCP1306 20/10mg