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

Phase 3

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Atorvastatin40mg, Ezetimibe placebo; Drug: Atorvastatin10mg, Ezetimibe10mg; Drug: Atorvastatin10mg, Ezetimibe placebo; Drug: Atorvastatin20mg, Ezetimibe10mg; Drug: Atorvastatin20mg, Ezetimibe placebo; Drug: Atorvastatin40mg, Ezetimibe10mg

• Registration Number: NCT02451098
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-21
• Primary Completion: 2015-10
• Status Verified: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin40mg, Ezetimibe placebo	Atorvastatin40mg, Ezetimibe placebo	Atorvastatin40mg, placebo will be administered (Duration 8 weeks)
Atorvastatin10mg, Ezetimibe10mg	Atorvastatin10mg, Ezetimibe10mg	Atorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks)
Atorvastatin10mg, Ezetimibe placebo	Atorvastatin10mg, Ezetimibe placebo	Atorvastatin10mg, placebo will be administered (Duration 8 weeks)
Atorvastatin20mg, Ezetimibe10mg	Atorvastatin20mg, Ezetimibe10mg	Atorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks)
Atorvastatin20mg, Ezetimibe placebo	Atorvastatin20mg, Ezetimibe placebo	Atorvastatin20mg, placebo will be administered (Duration 8 weeks)
Atorvastatin40mg, Ezetimibe10mg	Atorvastatin40mg, Ezetimibe10mg	Atorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Primary Outcome Measures

Name	Time	Method
Change form baseline in LDL-C	up to week 8

Secondary Outcome Measures

Name	Time	Method
Change form baseline in Apo-B ratio	up to week 20
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 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
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

Trial Locations

Locations (1)

The catholic university of korea seoul st. Mary's hospital; 🇰🇷 Seoul, Korea, Republic of