Status:
COMPLETED
Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)
Lead Sponsor:
Organon and Co
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target ...
Eligibility Criteria
Inclusion
- Patients with hypercholesterolemia who satisfy the following criteria:
- Patients who have used any of the following HMG-CoA reductase inhibitors (hereinafter referred to as "statins") for 4 weeks or longer before the start of the observation period and whose LDL-cholesterol level during the treatment had not reached lipid management target indicated below
- Age: 20 years of age or older (at the time of obtaining informed consent)
- Sex: both males and females
- Inpatient/outpatient: Out-patients
Exclusion
- Patients for whom any of the following is applicable:
- Patients whose fasted triglyceride level measured at the start of the observation period or the treatment period exceeds 500 mg/dL
- Patients with homozygous familial hypercholesterolemia
- Patients with creatine phosphokinase (CPK) \> 2x upper limit of normal (ULN) measured at the start of the observation period or the treatment period.
- Patients with serious hepatic disorder, or patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2x ULN measured at the start of the observation period or the treatment period.
- Patients with a history of hypersensitivity to any ingredient of ezetimibe tablets or simvastatin tablets
- Pregnant, nursing women, women who may be pregnant, or patients wishing to be pregnant during the study.
- Patients who have discontinued use of serum lipid lowering agents for less than 4 weeks at the start of the treatment period (8 weeks in the case of probucol). (However, if the patient had taken a serum lipid lowering agent before the test conducted at the start of the observation period, a period of discontinuation of 27 days, or 55 days in the case of probucol, is allowed.)
- Patients who are using cyclosporine from after the start of the observation period
- Patients who are using any of the following drug from after the start of the observation period: itraconazole, miconazole, atazanavir, saquinavir mesilate
- Patients with a history of ezetimibe use
- Patients with hyperlipidemia associated with the following diseases:
- Hypothyroidism
- Obstructive gall bladder or biliary disease
- Chronic renal failure
- Pancreatitis
- Patients with hyperlipidemia associated with concomitant use of drugs having adverse effect on serum lipids, etc
- Patients who have received an investigational drug within 4 weeks of the start of the observation period
- Other patients deemed not appropriate for study entry by the investigator
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00653523
Start Date
December 1 2007
End Date
June 1 2009
Last Update
May 21 2024
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