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

Read More

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

Read More

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)

Hjarthuset AB; 🇸🇪 Varberg, Sweden

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Angelholms Sjukhus, Medicinkliniken; 🇸🇪 Angelhom, Sweden

Hjartmottagningen; 🇸🇪 Malmo, Sweden

Narsjukhuset Sandviken, Kardiologlab, Medicin; 🇸🇪 Sandviken, Sweden

Hospital Universitario de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Clinico Universitario de Santiago; 🇪🇸 Santiago de Compostela, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

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

Sahlgrenska University Hospital, Intermedicin; 🇸🇪 Gothenburg, Sweden

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain

Frederiks Hospital, Kardiologisk; 🇩🇰 Frederiksberg, Denmark

Lakarcentrum Nyponet; 🇸🇪 Karineholm, Sweden

Medicinkliniken; 🇸🇪 Ludvika, Sweden

Huslakaren i Sandviken; 🇸🇪 Sandviken, Sweden

Karolinska Universitetssjukhuset; 🇸🇪 Stockholm, Sweden

Hjart & Karlcenter; 🇸🇪 Sodertalje, Sweden

Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

CCBR A/S; 🇩🇰 Vejle, Denmark

Hospital de Sagunto; 🇪🇸 Valencia, Spain

Hospital Universitario Reina Sofia; 🇪🇸 Cordoba, Spain

Kolesterollaboratoriet; 🇩🇰 Hellerup, Denmark

Mathenesserlaan 247; 🇳🇱 Rotterdam, Netherlands

Doezastraat 1; 🇳🇱 Leiden, Netherlands

Hospital Clinic i Provincial; 🇪🇸 Villaroel, Barcelona, Spain

Parkdreef 142; 🇳🇱 Zoetermeer, Netherlands

Bomanshof 8; 🇳🇱 Eindhoven, Netherlands

Damsterdiep 9; 🇳🇱 Groningen, Netherlands

Reigerstraat 30; 🇳🇱 Velp, Netherlands

Middellaan 5; 🇳🇱 Breda, Netherlands

Hospital Clinico S. Juan de Alicante; 🇪🇸 San Juan, Alicante, Spain

Kamerlingh Onnesstraat 16-18; 🇳🇱 Nijmegen, Netherlands