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

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

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial Design, Phase III Clinical Trial.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: Atorvastatin10mg, Ezetimibe10mg; Drug: Atorvastatin10mg, Ezetimibe placebo; Drug: Atorvastatin20mg, Ezetimibe10mg; Drug: Atorvastatin20mg, Ezetimibe placebo; Drug: Atorvastatin40mg, Ezetimibe10mg; Drug: Atorvastatin40mg, Ezetimibe placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 385
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic University of Korea Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atorvastatin10mg, Ezetimibe10mg; Atorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks)	Drug: Atorvastatin10mg, Ezetimibe10mg; Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks); Other Names: CKD-391
Active Comparator: Atorvastatin10mg, Ezetimibe placebo; Atorvastatin10mg, placebo will be administered (Duration 8 weeks)	Drug: Atorvastatin10mg, Ezetimibe placebo; Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks); Other Names: Lipitor
Experimental: Atorvastatin20mg, Ezetimibe10mg; Atorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks)	Drug: Atorvastatin20mg, Ezetimibe10mg; Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks); Other Names: CKD-391
Active Comparator: Atorvastatin20mg, Ezetimibe placebo; Atorvastatin20mg, placebo will be administered (Duration 8 weeks)	Drug: Atorvastatin20mg, Ezetimibe placebo; Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks); Other Names: Lipitor
Experimental: Atorvastatin40mg, Ezetimibe10mg; Atorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks)	Drug: Atorvastatin40mg, Ezetimibe10mg; Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks); Other Names: CKD-391
Active Comparator: Atorvastatin40mg, Ezetimibe placebo; Atorvastatin40mg, placebo will be administered (Duration 8 weeks)	Drug: Atorvastatin40mg, Ezetimibe placebo; Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks); Other Names: Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change form baseline in LDL-C	up to week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Change form baseline in LDL-C	up to week 20
Change form baseline in Total cholesterol	up to week 20
Change form baseline in Triglyceride	up to week 20
Change form baseline in HDL-C	up to week 20
Change form baseline in Non-HDL-C	up to week 20
Change form baseline in LDL-C/HDL-C ratio	up to week 20
Change form baseline in TC/HDL-C ratio	up to week 20
Change form baseline in Non-HDL-C/HDL-C ratio	up to week 20
Change form baseline in Apo-B ratio	up to week 20
Change form baseline in Apo-B	up to week 20
Change form baseline in Apo-A1	up to week 20
Change form baseline in Apo-B/Apo-A1 ratio	up to week 20

Other Outcome Measures

Outcome Measure	Time Frame
Evaluate safety of CKD-391 from adverse events, laboratory test results, physical examination, vital signs.	up to week 20

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Ho-Jung Yoon, PhD, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 18, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Ezetimibe
• Other Study ID Numbers: 152PDL14025