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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

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)