Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

NCT ID: NCT00871351

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-01
• Study Completion Date: 2010-05-01

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Conditions

Primary Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ezetimibe + Atorvastatin

Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg

Group Type: EXPERIMENTAL

Ezetimibe

Intervention Type: DRUG

1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)

Atorvastatin

Intervention Type: DRUG

1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)

Atorvastatin

Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)

Rosuvastatin

Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg

Group Type: ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)

Interventions

Ezetimibe

1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)

Intervention Type: DRUG

Atorvastatin

1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)

Intervention Type: DRUG

Atorvastatin

2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)

Intervention Type: DRUG

Rosuvastatin

1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)

Intervention Type: DRUG

Other Intervention Names

SCH 058235

Eligibility Criteria

Inclusion Criteria

• atorvastatin 10 mg monotherapy for 4 weeks or longer before the start of the 4-week washout and low density lipoprotein-cholesterol (LDL-C) levels that had not reached the following lipid management target values during treatment: Category I (low-risk group) with no other risk factors - LDL-C <160 mg/dL; Category II (mid-risk group) with 1-2 risk factors other than LDL-C levels - LDL-C <140 mg/dL; Category III (high-risk group) with 3 or more other risk factors - LDL-C <120 mg/dL; and for participants with history of coronary artery disease - LDL-C <100 mg/dL.
• outpatient men or women, age 20 years and older

Exclusion Criteria

• fasted triglyceride level at the start of washout or treatment period exceeding 400 mg/dL.
• homozygous familial hypercholesterolemia.
• creatine phosphokinase (CPK) >2 times the upper limit of normal (X ULN) at start of washout or treatment period.
• glycosylated hemoglobin (HbA1c) >=8％ at start of washout or treatment period.
• severe hepatic function disorder, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2X ULN at start of washout or treatment period.
• hypersensitivity to ezetimibe, atorvastatin, or rosuvastatin tablets.
• pregnant or lactating
• discontinued use of atorvastatin 10 mg for less than 4 weeks at start of treatment period (however, if participant had taken atorvastatin 10 mg before the test conducted at the start of the observation period, a period of discontinuation of 27 days is allowed.)
• cyclosporine treatment
• hyperlipidemia associated with hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure, and/or pancreatitis.
• hyperlipidemia associated with drug administration that causes adverse serum lipid effects.
• participation in a clinical study within 4 weeks of washout
• cancer or cancer history within previous 5 years, except for successfully treated basal cell carcinoma of the skin.

• 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

References

Teramoto T, Sawada T, Iwamoto K, Daida H. Clinical Efficacy and Tolerability of Ezetimibe in Combination With Atorvastatin in Japanese Patients With Hypercholesterolemia-Ezetimibe Phase IV Randomized Controlled Trial in Patients With Hypercholesterolemia. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):16-40. doi: 10.1016/j.curtheres.2012.02.002.

Reference Type: RESULT

PMID: 24653510 (View on PubMed)

Other Identifiers

P06027

Identifier Type: -

Identifier Source: org_study_id