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

A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1306 Tablet in Patients With Primary Hypercholesterolemia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02205606
Enrollment
412
Registered
2014-07-31
Start date
2014-06-30
Completion date
2015-04-30
Last updated
2015-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypercholesterolemia

Brief summary

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

Interventions

DRUGHGP0816 5mg

P.O.

DRUGHGP0816 10mg

P.O.

DRUGHGP0816 20mg

P.O.

DRUGHCP1306 5/10mg

P.O.

DRUGHCP1306 10/10mg

P.O.

DRUGHCP1306 20/10mg

P.O.

Sponsors

Hanmi Pharmaceutical Company Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frame
Percent change from baseline to 8 week in LDL-Cholesterolbaseline and 8 week

Secondary

MeasureTime frame
Percent change from baseline to 4 week in LDL-Cholesterolbaseline and 4 week
Percentage of patients reaching treatment goals according to NCEP ATP III Guidelineweek 4, week 8
Percent change from baseline to 4 week and 8 week in TCweek 4, week 8
Percent change from baseline to 4 week and 8 week in HDL-Cweek 4, week 8
Percent change from baseline to 4 week and 8 week in TGweek 4, week 8

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026