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NCT00309738 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 and 2 or More Risk Factors for Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00309738
Other study ID # NK-104-304
Secondary ID
Status Completed
Phase Phase 3
First received December 8, 2005
Last updated March 9, 2010
Start date September 2005
Est. completion date October 2006

Study information
Verified date March 2010
Source Kowa Research Europe
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products AgencySpain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 355
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 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• pitavastatin

• simvastatin

Locations
Country Name City State
Denmark CCBR A/S Aalborg
Denmark CCBR A/S Ballerup
Denmark Y Forskning, Bispebjerg Hospital Copenhagen NV
Denmark Frederiks Hospital, Kardiologisk Frederiksberg
Denmark Kolesterollaboratoriet Hellerup
Denmark CCBR A/S Vejle
Netherlands 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 Reigerstraat 30 Velp
Netherlands Parkdreef 142 Zoetermeer
Spain Hospital Universitario de Bellvitge Barcelona
Spain Hospital Vall d'Hebron Barcelona
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 Clinico S. Juan de Alicante San Juan Alicante
Spain Hospital Clinico Universitario de Santiago Santiago de Compostela
Spain Hospital de Sagunto Valencia
Spain Hospital Clinic i Provincial Villaroel Barcelona
Sweden Angelholms Sjukhus, Medicinkliniken Angelhom
Sweden Sahlgrenska University Hospital, Intermedicin Gothenburg
Sweden Hjartmottagningen Helsingborg
Sweden Lakarcentrum Nyponet Karineholm
Sweden Medicinkliniken Ludvika
Sweden Hjartmottagningen Malmo
Sweden Huslakaren i Sandviken Sandviken
Sweden Narsjukhuset Sandviken, Kardiologlab, Medicin Sandviken
Sweden Hjart & Karlcenter Sodertalje
Sweden Karolinska Universitetssjukhuset Stockholm
Sweden Hjarthuset AB Varberg

Sponsors (1)
Lead Sponsor Collaborator
Kowa Research Europe

Countries where clinical trial is conducted

Denmark,  Netherlands,  Spain,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in LDL-C Percent change from baseline in low density lipoprotein-cholesterol (LDL-C) 12 weeks No
Secondary Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL) Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL) 12 weeks No
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