Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)

Organon

Status and phase

Completed

Phase 3

Conditions

Hypercholesterolemia

Treatments

Drug: Ezetimibe

Drug: atorvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00654095

P05456

Details and patient eligibility

About

Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in participants with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors.

Enrollment

146 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants with hypercholesterolemia who satisfy the following criteria:
- Participants who have used any of the following 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (hereinafter referred to as "statins") for 4 weeks or longer before the start of the observation period and whose low density lipoprotein (LDL)-cholesterol level during the treatment had not reached lipid management target
- Age: 20 years of age or older (at the time of obtaining informed consent)
- Sex: both males and females
- Inpatient/outpatient: Out-patient

Exclusion criteria

Participants for whom any of the following is applicable:
- Participants whose fasted triglyceride level measured at the start of the observation period or the treatment period exceeds 500 mg/dL
- Participants with homozygous familial hypercholesterolemia
- Participants with creatine phosphokinase (CPK) > 2x upper limit of normal (ULN) measured at the start of the observation period or the treatment period.
- Participants with serious hepatic disorder, or participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x ULN measured at the start of the observation period or the treatment period.
- Participants with a history of hypersensitivity to any ingredient of ezetimibe tablets or atorvastatin tablets
- Pregnant, nursing women, women who may be pregnant, or participants wishing to be pregnant during the study.
- Participants 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 participant 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.)
- Participants who are using cyclosporine from after the start of the observation period
- Participants with a history of ezetimibe use
- Participants with hyperlipidemia associated with the following diseases:
  - Hypothyroidism
  - Obstructive gall bladder or biliary disease
  - Chronic renal failure
  - Pancreatitis
- Participants with hyperlipidemia associated with concomitant use of drugs having adverse effect on serum lipids, etc
- Participants who have received an investigational drug within 4 weeks of the start of the observation period
- Other participants deemed not appropriate for study entry by the investigator