Back to resultsEvaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
Primary Purpose
Primary Hypercholesterolemia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ezetimibe
Atorvastatin
Atorvastatin
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolemia
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Ezetimibe + Atorvastatin
Atorvastatin
Rosuvastatin
Arm Description
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
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Outcomes
Primary Outcome Measures
Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values
LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).
Secondary Outcome Measures
Percent Change in LDL-C
LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).
Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values
LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation).
Target values:
For participants with history of coronary artery disease: <100 mg/dL;
for participants with at least 3 cardiovascular (CV) risk factors: <120 mg/dL;
for participants with 1-2 CV risk factors: <140 mg/dL;
for participants with no CV risk factors: <160 mg/dL.
Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.
Percent Change in Total Lipids and Hs-CRP
Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00871351
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2009 (Actual)
Primary Completion Date
May 1, 2010 (Actual)
Study Completion Date
May 1, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ezetimibe + Atorvastatin
Arm Type
Experimental
Arm Description
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
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Arm Title
Rosuvastatin
Arm Type
Active Comparator
Arm Description
Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Other Intervention Name(s)
SCH 058235
Intervention Description
1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
1 tablet of 10 mg daily for 12 weeks (Weeks 5-16)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
2 tablets of 10 mg daily for 12 weeks (Weeks 5-16)
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
1 tablet of 2.5 mg daily for 12 weeks (Weeks 5-16)
Primary Outcome Measure Information:
Title
Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values
Description
LDL-C was measured before group study drug administration (Week 4, end of atorvastatin single therapy) and at the end of study drug administration (after 12 weeks of study drug treatment, or at discontinuation).
Time Frame
End of Week 4 to Week 16 or discontinuation
Secondary Outcome Measure Information:
Title
Percent Change in LDL-C
Description
LDL-C was measured at the start of the atorvastatin 10 mg treatment period (end of the washout period) and at the end of administration of the study drug (Week 16 or discontinuation).
Time Frame
End of washout period to Week 16 or discontinuation
Title
Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values
Description
LDL-C was measured at the end of administration of the study drug (Week 16 or discontinuation).
Target values:
For participants with history of coronary artery disease: <100 mg/dL;
for participants with at least 3 cardiovascular (CV) risk factors: <120 mg/dL;
for participants with 1-2 CV risk factors: <140 mg/dL;
for participants with no CV risk factors: <160 mg/dL.
Time Frame
Week 16 or discontinuation
Title
Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP)
Description
Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at 4 weeks after the start of the treatment period (after completion of administration of atorvastatin 10 mg alone) and at Week 16 or at discontinuation.
Time Frame
End of Week 4 to Week 16 or discontinuation
Title
Percent Change in Total Lipids and Hs-CRP
Description
Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and hs-CRP were measured at the start of the treatment period (at start of administration of atorvastatin 10 mg alone) and at the end of study drug (Week 16 or discontinuation).
Time Frame
End of washout to Week 16 or discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
24653510
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.
Results Reference
result
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Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
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