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
Overview
- Phase
- Phase 3
- Intervention
- Atorvastatin10mg, Ezetimibe10mg
- Conditions
- Hyperlipidemia
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 385
- Locations
- 1
- Primary Endpoint
- Change form baseline in LDL-C
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Atorvastatin10mg, Ezetimibe10mg
Atorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks)
Intervention: Atorvastatin10mg, Ezetimibe10mg
Atorvastatin10mg, Ezetimibe placebo
Atorvastatin10mg, placebo will be administered (Duration 8 weeks)
Intervention: Atorvastatin10mg, Ezetimibe placebo
Atorvastatin20mg, Ezetimibe10mg
Atorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks)
Intervention: Atorvastatin20mg, Ezetimibe10mg
Atorvastatin20mg, Ezetimibe placebo
Atorvastatin20mg, placebo will be administered (Duration 8 weeks)
Intervention: Atorvastatin20mg, Ezetimibe placebo
Atorvastatin40mg, Ezetimibe10mg
Atorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks)
Intervention: Atorvastatin40mg, Ezetimibe10mg
Atorvastatin40mg, Ezetimibe placebo
Atorvastatin40mg, placebo will be administered (Duration 8 weeks)
Intervention: Atorvastatin40mg, Ezetimibe placebo
Outcomes
Primary Outcomes
Change form baseline in LDL-C
Time Frame: up to week 8
Secondary Outcomes
- 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)