Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01285544
Other study ID # Lipinon Study
Secondary ID H-0807-056-251
Status Completed
Phase Phase 4
First received January 9, 2011
Last updated December 15, 2013
Start date September 2008
Est. completion date July 2009

Study information

Verified date December 2013
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

There will be no significant differences in the efficacy and tolerability between the test and reference formulations of atorvastatin 20 mg in these Korean adults with primary hypercholesterolemia.


Recruitment information / eligibility

Status Completed
Enrollment 289
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility Inclusion Criteria:

- the patients aged 20 to 79 years with primary hypercholesterolemia that was not sufficiently responsive to therapeutic lifestyle changes and had LDL-C level over 100 mg/dL in high risk group.

- Inclusion criteria was in accordance with drug treatment guidelines; coronary artery disease or equivalent group with LDL-C =100 mg/dl; patients with two or more risk factors and LDL-C=130 mg/dl; patients with 0 or 1 risk factor and LDL-C >160 mg/dl after therapeutic lifestyle changes

Exclusion Criteria:

- therapy with any other investigational drug within 30 days of randomization,

- history of hypersensitivity to HMG-CoA reductase inhibitors,

- uncontrolled hypertension,

- poorly controlled diabetes (glycosylated hemoglobin [HbA1c] >9%),

- unstable angina or presented with new-onset myocardial infarction (within 6 months),

- creatinine >2.5 mg/dl,

- alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), aspartate aminotransferase(AST) >2 x ULN, or creatine kinase (CK) >2 x ULN,

- history of malignancy or psychosis;

- chronic liver disease,

- drug or alcohol abuse, pregnancy, breastfeeding, failure to practice adequate contraception, cyclical hormonal contraceptives or intermittent use of hormone replacement therapies.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Atorvastatin (Lipinon)
treatment of dyslipidemia administration : PO, qod
Atorvastatin (Lipitor)
treatment of dyslipidemia administration : PO, qod

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital Dong-A Parmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary the percent change of LDL-C level After taken medication for 8 weeks No
Secondary the percent change in total cholesterol, triglyceride, high density lipoprotein cholesterol (HDL-C) level, apolipoprotein B/A1 ratio, LDL/HDL ratio, small dense LDL fraction, high-sensitive C reactive protein (hs-CRP) After taken medication for 8 weeks No
See also
  Status Clinical Trial Phase
Completed NCT02122198 - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women N/A
Completed NCT02502812 - Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects Phase 1
Recruiting NCT04216342 - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers Phase 1
Completed NCT03654313 - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus Phase 1
Completed NCT03646656 - Heart Health Buddies: Peer Support to Decrease CVD Risk N/A
Completed NCT02081066 - Identification of CETP as a Marker of Atherosclerosis N/A
Completed NCT02147626 - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia N/A
Not yet recruiting NCT06405880 - Pharmacist Case Finding and Intervention for Vascular Prevention Trial N/A
Recruiting NCT03095261 - Incentives in Cardiac Rehabilitation N/A
Not yet recruiting NCT02578355 - National Plaque Registry and Database N/A
Completed NCT02711878 - Healing Hearts and Mending Minds in Older Adults Living With HIV N/A
Completed NCT02998918 - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL N/A
Completed NCT02589769 - Effects of Reduction in Saturated Fat on Cholesterol and Lipoproteins in Lean and Obese Persons N/A
Completed NCT02868710 - Individual Variability to Aerobic Exercise Training N/A
Recruiting NCT02885792 - Coronary Artery Disease in Patients Suffering From Schizophrenia N/A
Completed NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A
Completed NCT02640859 - Investigation of Metabolic Risk in Korean Adults
Completed NCT02272946 - Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk Phase 2
Completed NCT02657382 - Mental Stress Ischemia: Biofeedback Study N/A
Recruiting NCT02265250 - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment