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NCT00309777 Clinical Trial

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Hypercholesterolemia Clinical Trial

Official title:
Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00309777
Other study ID # NK-104-302
Secondary ID EudraCT number 2
Status Completed
Phase Phase 3
First received November 11, 2005
Last updated January 7, 2010
Start date September 2005
Est. completion date October 2006

Study information
Verified date January 2010
Source Kowa Research Europe
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of HealthRussia: Pharmacological Committee, Ministry of HealthFinland: Ethics CommitteeUnited Kingdom: National Health ServiceNorway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Pitavastatin
Pitavastatin once daily
• Simvastatin
Simvastatin once daily

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Kowa Research Europe

Countries where clinical trial is conducted

Finland,  Italy,  Norway,  Russian Federation,  United Kingdom, 

Outcome
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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