NCT02205606CompletedPhase 3
A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1306 Tablet in Patients With Primary Hypercholesterolemia
Hanmi Pharmaceutical Company Limited1 site in 1 country412 target enrollmentStarted: June 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 412
- Locations
- 1
- Primary Endpoint
- Percent change from baseline to 8 week in LDL-Cholesterol
Study Overview
Brief Summary
The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with primary hypercholesterolemia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
HGP0816 5mg
Active Comparator
Intervention: HGP0816 5mg (Drug)
HGP0816 10mg
Active Comparator
Intervention: HGP0816 10mg (Drug)
HGP0816 20mg
Active Comparator
Intervention: HGP0816 20mg (Drug)
HCP1306 5/10mg
Experimental
Intervention: HCP1306 5/10mg (Drug)
HCP1306 10/10mg
Experimental
Intervention: HCP1306 10/10mg (Drug)
HCP1306 20/10mg
Experimental
Intervention: HCP1306 20/10mg (Drug)
Outcomes
Primary Outcomes
Percent change from baseline to 8 week in LDL-Cholesterol
Time Frame: baseline and 8 week
Secondary Outcomes
- Percent change from baseline to 4 week in LDL-Cholesterol(baseline and 4 week)
- Percent change from baseline to 4 week and 8 week in HDL-C(week 4, week 8)
- Percent change from baseline to 4 week and 8 week in TG(week 4, week 8)
- Percentage of patients reaching treatment goals according to NCEP ATP III Guideline(week 4, week 8)
- Percent change from baseline to 4 week and 8 week in TC(week 4, week 8)
Investigators
Study Sites (1)
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