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

NCT ID: NCT00654095

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 146 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 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.

Conditions

Hypercholesterolemia

Study Design

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

Study Groups

Ezetimibe + Atorvastatin

Ezetimibe 10 mg + Atorvastatin 20 mg

Group Type: EXPERIMENTAL

Ezetimibe

Intervention Type: DRUG

Ezetimibe 10 mg once daily

atorvastatin

Intervention Type: DRUG

atorvastatin 20 mg once daily

Interventions

Ezetimibe

Ezetimibe 10 mg once daily

Intervention Type: DRUG

atorvastatin

atorvastatin 20 mg once daily

Intervention Type: DRUG

Other Intervention Names

SCH 58235

Eligibility Criteria

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

• 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

P05456

Identifier Type: -

Identifier Source: org_study_id