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

Phase 3

Completed

• Conditions: Primary Hypercholesterolemia
• Interventions: Drug: HCP1306 10/10mg; Drug: HGP0816 10mg; Drug: HCP1306 5/10mg; Drug: HGP0816 20mg; Drug: HCP1306 20/10mg; Drug: HGP0816 5mg

• Registration Number: NCT02205606
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-07
• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Primary Completion: 2015-02
• Study Completion: 2015-04
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCP1306 10/10mg	HCP1306 10/10mg	-
HGP0816 10mg	HGP0816 10mg	-
HCP1306 5/10mg	HCP1306 5/10mg	-
HGP0816 20mg	HGP0816 20mg	-
HCP1306 20/10mg	HCP1306 20/10mg	-
HGP0816 5mg	HGP0816 5mg	-

Primary Outcome Measures

Name	Time	Method
Percent change from baseline to 8 week in LDL-Cholesterol	baseline and 8 week

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline to 4 week and 8 week in TG	week 4, week 8
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
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

Trial Locations

Locations (1)

19 institutions including Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of