Phase 4
Completed N=125
Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
Primary Hypercholesterolemia
Source: ClinicalTrials.gov NCT00871351 ↗
Enrolled (actual)
125
Serious AEs
4.0%
Results posted
Aug 2011
Primary outcomePrimary: Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values — -25.8; -15.1; 0.8 Percent change — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values |
-25.8; -15.1; 0.8 | <0.0001 sig |
| SECONDARY Percent Change in LDL-C |
-49.6; -41.1; -30.5 | 0.0003 sig |
| SECONDARY Number of Participants Whose LDL-C Levels Reached the Lipid Management Target Values |
37; 19; 1 | — |
| SECONDARY Percent Change in Total Lipids and High Sensitivity C-reactive Protein (Hs-CRP) |
-18.0; -10.3; 1.9; -0.8; 0.2; 14.7 | — |
| SECONDARY Percent Change in Total Lipids and Hs-CRP |
-39.9; -32.8; -24.4; -25.3; -18.8; -12.0 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT00871351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.