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

Chong Kun Dang

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia

Treatments: Drug: Atorvastatin10mg, Ezetimibe placebo; Drug: Atorvastatin20mg, Ezetimibe placebo; Drug: Atorvastatin20mg, Ezetimibe10mg; Drug: Atorvastatin40mg, Ezetimibe10mg; Drug: Atorvastatin40mg, Ezetimibe placebo; Drug: Atorvastatin10mg, Ezetimibe10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02451098

152PDL14025

Details and patient eligibility

About

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

Full 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.

Enrollment: 385 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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385 participants in 6 patient groups

Atorvastatin10mg, Ezetimibe10mg

Experimental group

Description:

Atorvastatin10mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Treatment:

Drug: Atorvastatin10mg, Ezetimibe10mg

Atorvastatin10mg, Ezetimibe placebo

Active Comparator group

Description:

Atorvastatin10mg, placebo will be administered (Duration 8 weeks)

Treatment:

Drug: Atorvastatin10mg, Ezetimibe placebo

Atorvastatin20mg, Ezetimibe10mg

Experimental group

Description:

Atorvastatin20mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Treatment:

Drug: Atorvastatin20mg, Ezetimibe10mg

Atorvastatin20mg, Ezetimibe placebo

Active Comparator group

Description:

Atorvastatin20mg, placebo will be administered (Duration 8 weeks)

Treatment:

Drug: Atorvastatin20mg, Ezetimibe placebo

Atorvastatin40mg, Ezetimibe10mg

Experimental group

Description:

Atorvastatin40mg, Ezetimibe10mg will be administered (Duration 8 weeks)

Treatment:

Drug: Atorvastatin40mg, Ezetimibe10mg

Atorvastatin40mg, Ezetimibe placebo

Active Comparator group

Description:

Atorvastatin40mg, placebo will be administered (Duration 8 weeks)

Treatment:

Drug: Atorvastatin40mg, Ezetimibe placebo