Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Phase 3

Completed

• Conditions: Hypercholesterolemia; Dyslipidemia
• Interventions: Drug: pitavastatin; Drug: simvastatin

• Registration Number: NCT00309738
• 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 in patients with risk factors for heart disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-12-08
• 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: 2009-12-11
• Results First Posted: 2010-01-18
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-09
• Last Update Posted: 2010-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

• Males and females (18-75 years of age)
• At least two cardiovascular disease risk factors
• Must have been following a restrictive diet
• Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria

• Homozygous familial hypercholesterolemia
• Conditions which may cause secondary dyslipidemia
• Uncontrolled diabetes mellitus
• Abnormal pancreatic, liver or renal function
• Abnormal serum creatine kinase (CK) above the pre-specified level

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin 4 mg QD	pitavastatin	Pitavastatin 4 mg once daily
Simvastatin 40 mg QD	simvastatin	Simvastatin 40 mg once daily

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in LDL-C	12 weeks	Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)

Secondary Outcome Measures

Name	Time	Method
Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)	12 weeks	Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (\< 160 mg/dL)

Trial Locations

Locations (32)

CCBR A/S; 🇩🇰 Vejle, Denmark

Y Forskning, Bispebjerg Hospital; 🇩🇰 Copenhagen NV, Denmark

Frederiks Hospital, Kardiologisk; 🇩🇰 Frederiksberg, Denmark

Kolesterollaboratoriet; 🇩🇰 Hellerup, Denmark

Middellaan 5; 🇳🇱 Breda, Netherlands

Bomanshof 8; 🇳🇱 Eindhoven, Netherlands

Damsterdiep 9; 🇳🇱 Groningen, Netherlands

Doezastraat 1; 🇳🇱 Leiden, Netherlands

Kamerlingh Onnesstraat 16-18; 🇳🇱 Nijmegen, Netherlands

Mathenesserlaan 247; 🇳🇱 Rotterdam, Netherlands

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