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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Treatments: Atorvastatin; Atorvastatin Calcium; Ezetimibe

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.