Clinical trial NCT00653523: Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)
Official title: Open-label, Long-term Study of Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia Who Have Not Reached LDL-cholesterol Target With HMG-CoA Reductase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 151
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Participants With Adverse Events and Adverse Reactions
timeFrame: Throughout 1 year of study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: