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

Primary Purpose

Primary Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HGP0816 5mg
HGP0816 10mg
HGP0816 20mg
HCP1306 5/10mg
HCP1306 10/10mg
HCP1306 20/10mg
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • 19 institutions including Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Arm Label

HGP0816 5mg

HGP0816 10mg

HGP0816 20mg

HCP1306 5/10mg

HCP1306 10/10mg

HCP1306 20/10mg

Arm Description

Outcomes

Primary Outcome Measures

Percent change from baseline to 8 week in LDL-Cholesterol

Secondary Outcome Measures

Percent change from baseline to 4 week in LDL-Cholesterol
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline
Percent change from baseline to 4 week and 8 week in TC
Percent change from baseline to 4 week and 8 week in HDL-C
Percent change from baseline to 4 week and 8 week in TG

Full Information

First Posted
July 30, 2014
Last Updated
September 21, 2015
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02205606
Brief Title
Efficacy/Safety of HCP1306 Tablet Versus HGP0816 Tablet in Patients With Primary Hypercholesterolemia
Official Title
A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1306 Tablet in Patients With Primary Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
412 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HGP0816 5mg
Arm Type
Active Comparator
Arm Title
HGP0816 10mg
Arm Type
Active Comparator
Arm Title
HGP0816 20mg
Arm Type
Active Comparator
Arm Title
HCP1306 5/10mg
Arm Type
Experimental
Arm Title
HCP1306 10/10mg
Arm Type
Experimental
Arm Title
HCP1306 20/10mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HGP0816 5mg
Intervention Description
P.O.
Intervention Type
Drug
Intervention Name(s)
HGP0816 10mg
Intervention Description
P.O.
Intervention Type
Drug
Intervention Name(s)
HGP0816 20mg
Intervention Description
P.O.
Intervention Type
Drug
Intervention Name(s)
HCP1306 5/10mg
Intervention Description
P.O.
Intervention Type
Drug
Intervention Name(s)
HCP1306 10/10mg
Intervention Description
P.O.
Intervention Type
Drug
Intervention Name(s)
HCP1306 20/10mg
Intervention Description
P.O.
Primary Outcome Measure Information:
Title
Percent change from baseline to 8 week in LDL-Cholesterol
Time Frame
baseline and 8 week
Secondary Outcome Measure Information:
Title
Percent change from baseline to 4 week in LDL-Cholesterol
Time Frame
baseline and 4 week
Title
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline
Time Frame
week 4, week 8
Title
Percent change from baseline to 4 week and 8 week in TC
Time Frame
week 4, week 8
Title
Percent change from baseline to 4 week and 8 week in HDL-C
Time Frame
week 4, week 8
Title
Percent change from baseline to 4 week and 8 week in TG
Time Frame
week 4, week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo-soo Kim, MD, Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
19 institutions including Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31727361
Citation
Rhee MY, Kim KJ, Kim SH, Yoon YW, Rha SW, Hong SJ, Kwak CH, Kim W, Nam CW, Park TH, Hong TJ, Park S, Ahn Y, Lee N, Jeon HK, Jeon DW, Han KR, Moon KW, Chae IH, Kim HY, Kim HS. Ezetimibe and Rosuvastatin Combination Treatment Can Reduce the Dose of Rosuvastatin Without Compromising Its Lipid-lowering Efficacy. Clin Ther. 2019 Dec;41(12):2571-2592. doi: 10.1016/j.clinthera.2019.10.010. Epub 2019 Nov 11.
Results Reference
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Efficacy/Safety of HCP1306 Tablet Versus HGP0816 Tablet in Patients With Primary Hypercholesterolemia

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