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Clinical Trial to Evaluate the Efficacy and Safety of CKD-391

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin10mg, Ezetimibe10mg
Atorvastatin10mg, Ezetimibe placebo
Atorvastatin20mg, Ezetimibe10mg
Atorvastatin20mg, Ezetimibe placebo
Atorvastatin40mg, Ezetimibe10mg
Atorvastatin40mg, Ezetimibe placebo
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

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

Inclusion Criteria:

  • Adult, at least 19 years of age.
  • Hyperlipidemia patient of LDL-C≤250 mg/dl and TG ≤400 mg/dl
  • Patients requiring anti-dyslipidemia drug therapy [based on the NCEP ATP III(2002)]
  • Drug compliance during Run-in period ≥70%
  • Patients must willing to the study and signed an informed consent

Exclusion Criteria:

  • Patients with myopathy included rhabdomyolysis or CPK level≥2xULN
  • Patients with acute arterial disease
  • Patients with renal dysfunction or Serum creatinine level ≥2x ULN
  • Patients with liver dysfunction or ALT, AST level > 2xULN
  • Patients with medical history within 6 months prior to screening visit (Heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease)
  • Patient with uncontrolled disease (diabetes mellitus as HbA1c level of > 9.0%, hypertension as SBP≥180mmHg or DBP≥110mmHg, hypothyroidism as TSH≥1.5xULN)
  • Patients who have a history or presence of active malignancy within 5 years
  • Patients with difficulty of stop taking lipid-lowering agents during run-in period.
  • Patients who have taken another investigational drug within 4 weeks prior to screening visit.

Sites / Locations

  • The catholic university of korea seoul st. Mary's hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Atorvastatin10mg, Ezetimibe10mg

Atorvastatin10mg, Ezetimibe placebo

Atorvastatin20mg, Ezetimibe10mg

Atorvastatin20mg, Ezetimibe placebo

Atorvastatin40mg, Ezetimibe10mg

Atorvastatin40mg, Ezetimibe placebo

Arm Description

Atorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Atorvastatin10mg, placebo will be administered (Duration 8 weeks)

Atorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Atorvastatin20mg, placebo will be administered (Duration 8 weeks)

Atorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Atorvastatin40mg, placebo will be administered (Duration 8 weeks)

Outcomes

Primary Outcome Measures

Change form baseline in LDL-C

Secondary Outcome Measures

Change form baseline in LDL-C
Change form baseline in Total cholesterol
Change form baseline in Triglyceride
Change form baseline in HDL-C
Change form baseline in Non-HDL-C
Change form baseline in LDL-C/HDL-C ratio
Change form baseline in TC/HDL-C ratio
Change form baseline in Non-HDL-C/HDL-C ratio
Change form baseline in Apo-B ratio
Change form baseline in Apo-B
Change form baseline in Apo-A1
Change form baseline in Apo-B/Apo-A1 ratio

Full Information

First Posted
May 18, 2015
Last Updated
January 26, 2016
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02451098
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of CKD-391
Official Title
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Factorial Design, Phase III Clinical Trial To Evaluate the Efficacy and Safety of Atorvastatin+Ezetimibe Combination Therapy and Atorvastatin Monotherapy in Patients With Primary Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.
Detailed Description
The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-391 once daily for 8 weeks in patients with primary hypercholesterolemia. Furthermore, the extension study for additional 12 weeks is designed to confirm long term safety of CKD-391.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin10mg, Ezetimibe10mg
Arm Type
Experimental
Arm Description
Atorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks)
Arm Title
Atorvastatin10mg, Ezetimibe placebo
Arm Type
Active Comparator
Arm Description
Atorvastatin10mg, placebo will be administered (Duration 8 weeks)
Arm Title
Atorvastatin20mg, Ezetimibe10mg
Arm Type
Experimental
Arm Description
Atorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks)
Arm Title
Atorvastatin20mg, Ezetimibe placebo
Arm Type
Active Comparator
Arm Description
Atorvastatin20mg, placebo will be administered (Duration 8 weeks)
Arm Title
Atorvastatin40mg, Ezetimibe10mg
Arm Type
Experimental
Arm Description
Atorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks)
Arm Title
Atorvastatin40mg, Ezetimibe placebo
Arm Type
Active Comparator
Arm Description
Atorvastatin40mg, placebo will be administered (Duration 8 weeks)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin10mg, Ezetimibe10mg
Other Intervention Name(s)
CKD-391
Intervention Description
Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin10mg, Ezetimibe placebo
Other Intervention Name(s)
Lipitor
Intervention Description
Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin20mg, Ezetimibe10mg
Other Intervention Name(s)
CKD-391
Intervention Description
Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin20mg, Ezetimibe placebo
Other Intervention Name(s)
Lipitor
Intervention Description
Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin40mg, Ezetimibe10mg
Other Intervention Name(s)
CKD-391
Intervention Description
Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin40mg, Ezetimibe placebo
Other Intervention Name(s)
Lipitor
Intervention Description
Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)
Primary Outcome Measure Information:
Title
Change form baseline in LDL-C
Time Frame
up to week 8
Secondary Outcome Measure Information:
Title
Change form baseline in LDL-C
Time Frame
up to week 20
Title
Change form baseline in Total cholesterol
Time Frame
up to week 20
Title
Change form baseline in Triglyceride
Time Frame
up to week 20
Title
Change form baseline in HDL-C
Time Frame
up to week 20
Title
Change form baseline in Non-HDL-C
Time Frame
up to week 20
Title
Change form baseline in LDL-C/HDL-C ratio
Time Frame
up to week 20
Title
Change form baseline in TC/HDL-C ratio
Time Frame
up to week 20
Title
Change form baseline in Non-HDL-C/HDL-C ratio
Time Frame
up to week 20
Title
Change form baseline in Apo-B ratio
Time Frame
up to week 20
Title
Change form baseline in Apo-B
Time Frame
up to week 20
Title
Change form baseline in Apo-A1
Time Frame
up to week 20
Title
Change form baseline in Apo-B/Apo-A1 ratio
Time Frame
up to week 20
Other Pre-specified Outcome Measures:
Title
Evaluate safety of CKD-391 from adverse events, laboratory test results, physical examination, vital signs.
Time Frame
up to week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult, at least 19 years of age. Hyperlipidemia patient of LDL-C≤250 mg/dl and TG ≤400 mg/dl Patients requiring anti-dyslipidemia drug therapy [based on the NCEP ATP III(2002)] Drug compliance during Run-in period ≥70% Patients must willing to the study and signed an informed consent Exclusion Criteria: Patients with myopathy included rhabdomyolysis or CPK level≥2xULN Patients with acute arterial disease Patients with renal dysfunction or Serum creatinine level ≥2x ULN Patients with liver dysfunction or ALT, AST level > 2xULN Patients with medical history within 6 months prior to screening visit (Heart failure, uncontrolled arrhythmia, drug and alcohol abuse history, gastrointestinal disease or surgery, anticoagulation disease) Patient with uncontrolled disease (diabetes mellitus as HbA1c level of > 9.0%, hypertension as SBP≥180mmHg or DBP≥110mmHg, hypothyroidism as TSH≥1.5xULN) Patients who have a history or presence of active malignancy within 5 years Patients with difficulty of stop taking lipid-lowering agents during run-in period. Patients who have taken another investigational drug within 4 weeks prior to screening visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho-Jung Yoon, PhD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
The catholic university of korea seoul st. Mary's hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial to Evaluate the Efficacy and Safety of CKD-391

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