Hyperlipidemia
Conditions
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.
Interventions
DRUGAtorvastatin10mg, Ezetimibe10mg
Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)
DRUGAtorvastatin10mg, Ezetimibe placebo
Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)
DRUGAtorvastatin20mg, Ezetimibe10mg
Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)
DRUGAtorvastatin20mg, Ezetimibe placebo
Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)
DRUGAtorvastatin40mg, Ezetimibe10mg
Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)
DRUGAtorvastatin40mg, Ezetimibe placebo
Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change form baseline in LDL-C | up to week 8 |
Secondary
| 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 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 |
| Change form baseline in TC/HDL-C ratio | up to week 20 |
Other
| Measure | Time frame |
|---|---|
| Evaluate safety of CKD-391 from adverse events, laboratory test results, physical examination, vital signs. | up to week 20 |
Countries
South Korea
Outcome results
None listed