Assessment of the Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia : A Multicenter, Prospective, Open-Label, Randomized, Trial
| Registry | NCT01285544 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 289 (Actual) |
| Sponsor | Seoul National University Hospital (Other); collaborators: Dong-A Pharmaceutical |
| Conditions | Dyslipidemia, Cardiovascular Disease, Hypercholesterolemia |
| Interventions | Atorvastatin (Lipinon), Atorvastatin (Lipitor) (Drug) |
| Dates | start 2008-09-01, primary completion 2009-07-01, completion 2009-07-01, first posted 2011-01-28, last updated 2013-12-17 |
| Locations | 1 site in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Dyslipidemia All trials for Cardiovascular Disease All trials of Atorvastatin (Lipinon) All trials of Atorvastatin (Lipitor)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Lipinon-test formulation of atrovastain - 20mg | Experimental | Drug: Atorvastatin (Lipinon) | |
| Lipitor- branded formuation of atorvastatin-20mg | Active comparator | Drug: Atorvastatin (Lipitor) |
Sex: All, ages: 20 Years to 79 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |