A Phase 3 interventional study of pitavastatin and simvastatin in Hypercholesterolemia and Dyslipidemia, sponsored by Kowa Research Europe. Completed at 35 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-03-16.
Sponsored by Kowa Research Europe · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.
1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.
This study's enrollment of 355 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Kowa Research Europe is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pitavastatin 4 mg once daily
Drug: pitavastatin
Simvastatin 40 mg once daily
Drug: simvastatin
Percent Change From Baseline in LDL-C
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Time frame: 12 weeks
Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)
Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (\< 160 mg/dL)
Time frame: 12 weeks
Subjects were enrolled from September 2005 to October 2006 at 43 investigator sites.
| Milestone | Pitavastatin 4 mg QD | Simvastatin 40 mg QD |
|---|---|---|
| Started | 236 | 119 |
| Safety population | 233 | 119 |
| Completed | 223 | 107 |
| Not completed | 13 | 12 |
Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
| mg/dL | Pitavastatin 4 mg QD | Simvastatin 40 mg QD |
|---|---|---|
| Percent Change From Baseline in LDL-C | -43.96 ± 12.770 | -43.77 ± 14.416 |
Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (\< 160 mg/dL)
| participants | Pitavastatin 4 mg QD | Simvastatin 40 mg QD |
|---|---|---|
| Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL) | 203 | 101 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pitavastatin 4 mg QD | — | — | — |
| Simvastatin 40 mg QD | — | — | — |
| Event | Pitavastatin 4 mg QD | Simvastatin 40 mg QD |
|---|---|---|
| LymphadenopathyBlood and lymphatic system disorders | 0/233 | 1/119 |
| cholelithiasisHepatobiliary disorders | 0/233 | 1/119 |
| CystitisInfections and infestations | 0/233 | 1/119 |
| SyncopeNervous system disorders | 0/233 | 1/119 |
| Aortic aneurysmVascular disorders | 0/233 | 1/119 |
| Acute coronary syndromeCardiac disorders | 1/233 | 0/119 |
| Myocardial infarctionCardiac disorders | 1/233 | 0/119 |
| GastritisGastrointestinal disorders | 1/233 | 0/119 |
| peritonsilar abscessInfections and infestations | 1/233 | 0/119 |
| Event | Pitavastatin 4 mg QD | Simvastatin 40 mg QD |
|---|---|---|
| HeadacheNervous system disorders | 13/233 | 3/119 |
| NasopharyngitisInfections and infestations | 11/233 | 3/119 |
| ConsitpationGastrointestinal disorders | 10/233 | 2/119 |
| HypertensionVascular disorders | 10/233 | 0/119 |
| MyalgiaMusculoskeletal and connective tissue disorders | 7/233 | 5/119 |
| Age, Categorical(Participants) | Pitavastatin 4 mg QD | Simvastatin 40 mg QD | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 184 | 88 | 272 |
| >=65 years | 49 | 31 | 80 |
| Age Continuous(years) | Pitavastatin 4 mg QD | Simvastatin 40 mg QD | Total |
|---|---|---|---|
| Mean | 60.1 ± 6.82 | 60.9 ± 6.78 | 60.3 ± 6.81 |
| Sex: Female, Male(Participants) | Pitavastatin 4 mg QD | Simvastatin 40 mg QD | Total |
|---|---|---|---|
| Female | 75 | 37 | 112 |
| Male | 158 | 82 | 240 |
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Kowa Research Europe