Clinical Trial to Evaluate the Efficacy and Safety of CKD-391
Information source: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemia
Intervention: Atorvastatin10mg, Ezetimibe10mg (Drug); Atorvastatin10mg, Ezetimibe placebo (Drug); Atorvastatin20mg, Ezetimibe10mg (Drug); Atorvastatin20mg, Ezetimibe placebo (Drug); Atorvastatin40mg, Ezetimibe10mg (Drug); Atorvastatin40mg, Ezetimibe placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Chong Kun Dang Pharmaceutical Official(s) and/or principal investigator(s): Ho-Jung Yoon, PhD, Principal Investigator, Affiliation: The Catholic University of Korea
Overall contact: A-ra Cho, Email: choara@ckdpharm.com
Summary
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Factorial
Design, Phase III Clinical Trial.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change form baseline in LDL-C
Secondary outcome: Change form baseline in LDL-CChange form baseline in Total cholesterol Change form baseline in Triglyceride Change form baseline in HDL-C Change form baseline in Non-HDL-C Change form baseline in LDL-C/HDL-C ratio Change form baseline in TC/HDL-C ratio Change form baseline in Non-HDL-C/HDL-C ratio Change form baseline in Apo-B ratio Change form baseline in Apo-B Change form baseline in Apo-A1 Change form baseline in Apo-B/Apo-A1 ratio
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
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
A-ra Cho, Email: choara@ckdpharm.com
The catholic university of korea seoul st. Mary's hospital, Seoul, Korea, Republic of; Recruiting Ho-Jung Youn, PhD, Email: younhj@catholic.ac.kr
Additional Information
Starting date: March 2015
Last updated: May 20, 2015
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