Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Condition(s) targeted: Hypercholesterolemia; Dyslipidemia

Intervention: pitavastatin (Drug); simvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Kowa Research Europe

Official(s) and/or principal investigator(s):
Klaus Giersch, Med Dr., Study Director, Affiliation: Vice President

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.

Official title: Study of Pitavastatin Vs. Simvastatin (Following Up-Titration) in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia and 2 or More Risk Factors for Coronary Heart Disease

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)

Secondary outcome:

Changes from baseline in other lipid and lipoprotein fractions

Safety and tolerability of pitavastatin

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

CCBR a/S, Aalborg, Denmark

CCBR a/S, Vejle, Denmark

CCBR a/S, Ballerup, Denmark

Kolesterollaboratoriet, Hellerup, Denmark

Y Forskning, Bispebjerg Hospital, Copenhagen NV, Denmark

Frederiks Hospital, Kardiologisk, Frederiksberg, Denmark

Mathenesserlaan 247, Rotterdam, Netherlands

Damsterdiep 9, Groningen, Netherlands

Parkdreef 142, Zoetermeer, Netherlands

Reigerstraat 30, Velp, Netherlands

Doezastraat 1, Leiden, Netherlands

Kamerlingh Onnesstraat 16-18, Nijmegen, Netherlands

Middellaan 5, Breda, Netherlands

Bomanshof 8, Eindhoven, Netherlands

Hospital Universitario de Bellvitge, Barcelona, Spain

Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain

Hospital de Sagunto, Valencia, Spain

Hospital Universitario Reina Sofia, Cordoba, Spain

Fundacion Jimenez Diaz, Madrid, Spain

Hospital Clinico San Carlos, Madrid, Spain

Hospital Ramon y Cajal, Madrid, Spain

Hospital Vall d'Hebron, Barcelona, Spain

Karolinska Universitetssjukhuset, Stockholm, Sweden

Medicinkliniken, Ludvika, Sweden

Angelholms Sjukhus, Medicinkliniken, Angelhom, Sweden

Hjartmottagningen, Malmo, Sweden

Narsjukhuset Sandviken, Kardiologlab, Medicin, Sandviken, Sweden

Hjarthuset AB, Varberg, Sweden

Hjartmottagningen, Helsingborg, Sweden

Lakarcentrum Nyponet, Karineholm, Sweden

Hjart & Karlcenter, Sodertalje, Sweden

Huslakaren i Sandviken, Sandviken, Sweden

Sahlgrenska University Hospital, Intermedicin, Gothenburg, Sweden

Hospital Clinico S. Juan de Alicante, San Juan, Alicante, Spain

Hospital Clinic i Provincial, Villaroel, Barcelona, Spain

Starting date: November 2005
Last updated: February 28, 2007