Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Phase 3

Completed

• Conditions: Hypercholesterolemia; Dyslipidemia
• Interventions: Drug: Pitavastatin; Drug: Simvastatin

• Registration Number: NCT00309777
• Lead Sponsor: Kowa Research Europe

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-11-11
• Study First Submitted QC: 2006-03-31
• Study First Posted: 2006-04-03
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Results First Submitted: 2009-08-26
• Results First Submitted QC: 2009-11-13
• Results First Posted: 2009-12-16
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-07
• Last Update Posted: 2010-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 857

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin 2 mg	Pitavastatin	Pitavastatin 2 mg once daily
Simvastatin 20 mg	Simvastatin	Simvastatin 20 mg once daily
Pitavastatin 4 mg	Pitavastatin	Pitavastatin 4 mg once daily
Simvastatin 40 mg	Simvastatin	Simvastatn 40 mg once daily

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks	Baseline to 12 weeks	Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks

Secondary Outcome Measures

Name	Time	Method
National Cholesterol Education Program (NCEP) LDL-C Target Attainment	12 week	Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12

Trial Locations

Locations (42)

Geri-Med Oy; 🇫🇮 Helsinki, Finland

Kaisaniemen Laakariasema; 🇫🇮 Helsinki, Finland

Keravan Laakarikeskus; 🇫🇮 Helsinki, Finland

SOK-tyoterveyshuolto; 🇫🇮 Tampere, Finland

TYKS University Hospital; 🇫🇮 Turku, Finland

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

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