Clinical trial NCT00871351: Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
Official title: Ezetimibe Phase IV Clinical Study in Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values
timeFrame: End of Week 4 to Week 16 or discontinuation
Secondary outcomes:
measure: Percent Change in LDL-C
timeFrame: End of washout period to Week 16 or discontinuation
measure: Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values
timeFrame: Week 16 or discontinuation
measure: Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
timeFrame: End of Week 4 to Week 16 or discontinuation
measure: Percent Change in Total Lipids and Hs-CRP
timeFrame: End of washout to Week 16 or discontinuation
Other outcomes:
Locations:
Study officials:
References:
citation: 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.