Hypercholesterolemia Clinical Trial
Official title:
Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.
Status | Completed |
Enrollment | 857 |
Est. completion date | October 2006 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Males and females (18-75 years) - Must have been following a restrictive diet - Diagnosis of primary hypercholesterolemia or combined dyslipidemia Exclusion Criteria: - Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia; - Conditions which may cause secondary dyslipidemia. - Uncontrolled diabetes mellitus (by hemoglobin A1c [HbA1c] > 8%) - Abnormal serum creatine kinase (CK) above the pre-specified level - Abnormal pancreatic, liver or renal function - Significant heart disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Geri-Med Oy | Helsinki | |
Finland | Kaisaniemen Laakariasema | Helsinki | |
Finland | Keravan Laakarikeskus | Helsinki | |
Finland | SOK-tyoterveyshuolto | Tampere | |
Finland | TYKS University Hospital | Turku | |
Italy | Dipartimento Di Medicina Clinica e Biotecnologia Applicata | Bologna | |
Italy | Centro di Ricerca Clinica | Chieti | |
Italy | Gerontologia e Geriatria - Universita degli Studi | Ferrara | |
Italy | Dipartimento di Medicina Interna DIMI | Genova | |
Italy | Universita di Modena e Reggio Emilia, Policlinico | Modena | |
Italy | Dipartimento di Medicina Clinica e Sperimentale | Napoli | |
Italy | Medicina Clinica e delle Patologie Emergenti | Palermo | |
Italy | Dipartimento di Medicina Interna e Scienze Biomediche | Parma | |
Italy | U.O Malattie Metaboliche e Diabetologia | Treviglio | |
Italy | Azienda Ospedaliero-Universitaria | Trieste | |
Norway | Volvat Medisinske Senter | Fredrikstad | |
Norway | Nyomen Legekontor | Kongsberg | |
Norway | Radhuset Spesialistsenter | Oslo | |
Norway | Rikshospitalet - University Hospital | Oslo | |
Norway | Skedsmo Medisinske Senter A.S. | Skedsmokorset | |
Russian Federation | Kemerovo Cardiology Dispensary | Kemerovo | |
Russian Federation | Central Clinical Hospital 1 of RZD | Moscow | |
Russian Federation | City Clinical Hospital 23 | Moscow | |
Russian Federation | City Clinical Hospital 64 | Moscow | |
Russian Federation | Moscow City Clinical Hospital 68 | Moscow | |
Russian Federation | State Research Center for Preventive Medicine | Moscow | |
Russian Federation | Novosibirsk Reg. Clinical Cardiology Dispensary | Novosibirsk | |
Russian Federation | Central Medical Unit 122, St. Pb | Saint Petersburg | |
Russian Federation | Clinical Hospital of Russian Academy of Sciences | Saint Petersburg | |
Russian Federation | Consulting and Diagnostic Center 85 | Saint Petersburg | |
Russian Federation | Krestovsky Island Medical Institute | Saint Petersburg | |
Russian Federation | Pokrovskaya City Hospital | Saint Petersburg | |
United Kingdom | St Michael's Partnership | Bath | |
United Kingdom | Avondale Surgery | Chesterfield | |
United Kingdom | Knowle House Surgery | Plymouth | |
United Kingdom | The Burngreave Surgery | Sheffield | |
United Kingdom | St Helier Hospital | Surrey | |
United Kingdom | Box Surgery | Wiltshire | |
United Kingdom | Eastleigh Surgery | Wiltshire | |
United Kingdom | Lovemead Group Practice | Wiltshire | |
United Kingdom | St Chad's Surgery | Wiltshire | |
United Kingdom | The Health Centre | Wiltshire |
Lead Sponsor | Collaborator |
---|---|
Kowa Research Europe |
Finland, Italy, Norway, Russian Federation, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks | Baseline to 12 weeks | No | |
Secondary | National Cholesterol Education Program (NCEP) LDL-C Target Attainment | 12 week | No |
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