Status:
COMPLETED
Efficacy/Safety of HCP1306 Tablet Versus HGP0816 Tablet in Patients With Primary Hypercholesterolemia
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Primary Hypercholesterolemia
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with primary hypercholesterolemia.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT02205606
Start Date
June 1 2014
End Date
April 1 2015
Last Update
September 22 2015
Active Locations (1)
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1
19 institutions including Seoul National University Hospital
Seoul, South Korea