Clinical trial NCT02451098: Clinical Trial to Evaluate the Efficacy and Safety of CKD-391
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-05-21
Enrollment: 385
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change form baseline in LDL-C
timeFrame: up to week 8
Secondary outcomes:
measure: Change form baseline in LDL-C
timeFrame: up to week 20
measure: Change form baseline in Total cholesterol
timeFrame: up to week 20
measure: Change form baseline in Triglyceride
timeFrame: up to week 20
measure: Change form baseline in HDL-C
timeFrame: up to week 20
measure: Change form baseline in Non-HDL-C
timeFrame: up to week 20
measure: Change form baseline in LDL-C/HDL-C ratio
timeFrame: up to week 20
measure: Change form baseline in TC/HDL-C ratio
timeFrame: up to week 20
measure: Change form baseline in Non-HDL-C/HDL-C ratio
timeFrame: up to week 20
measure: Change form baseline in Apo-B ratio
timeFrame: up to week 20
measure: Change form baseline in Apo-B
timeFrame: up to week 20
measure: Change form baseline in Apo-A1
timeFrame: up to week 20
measure: Change form baseline in Apo-B/Apo-A1 ratio
timeFrame: up to week 20
Other outcomes:
measure: Evaluate safety of CKD-391 from adverse events, laboratory test results, physical examination, vital signs.
timeFrame: up to week 20
Locations:
city: Seoul
country: Korea, Republic of
facility: The catholic university of korea seoul st. Mary's hospital
Study officials:
affiliation: The Catholic University of Korea
name: Ho-Jung Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References: