Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)

NCT ID: NCT00653523

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-01
• Study Completion Date: 2009-06-01

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ezetimibe + Simvastatin

Ezetimibe 10 mg + Simvastatin 20 mg

Group Type: EXPERIMENTAL

Ezetimibe

Intervention Type: DRUG

Ezetimibe 10 mg once daily

Simvastatin

Intervention Type: DRUG

Simvastatin 20 mg daily

Interventions

Ezetimibe

Ezetimibe 10 mg once daily

Intervention Type: DRUG

Simvastatin

Simvastatin 20 mg daily

Intervention Type: DRUG

Other Intervention Names

SCH 58235

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P05457

Identifier Type: -

Identifier Source: org_study_id