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

Primary Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205606
• Other study ID #: HM-ROZE-301
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2014
• Last updated: September 21, 2015
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: July 2014
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

Drug:
• HGP0816 5mg
P.O.
• HGP0816 10mg
P.O.
• HGP0816 20mg
P.O.
• HCP1306 5/10mg
P.O.
• HCP1306 10/10mg
P.O.
• HCP1306 20/10mg
P.O.

Locations

Country	Name	City	State
Korea, Republic of	19 institutions including Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline to 8 week in LDL-Cholesterol		baseline and 8 week	No
Secondary	Percent change from baseline to 4 week in LDL-Cholesterol		baseline and 4 week	No
Secondary	Percentage of patients reaching treatment goals according to NCEP ATP III Guideline		week 4, week 8	No
Secondary	Percent change from baseline to 4 week and 8 week in TC		week 4, week 8	No
Secondary	Percent change from baseline to 4 week and 8 week in HDL-C		week 4, week 8	No
Secondary	Percent change from baseline to 4 week and 8 week in TG		week 4, week 8	No