Clinical trial NCT00309738: Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Dyslipidemia
Keywords: Kowa
KRE
Hypercholesterolemia
combined dyslipidemia
dyslipidemia
pitavastatin
NK-104
simvastatin
Lead sponsor: Kowa Research Europe
Sponsor class: INDUSTRY
First posted: 2006-04-03
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline in LDL-C
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: CCBR A/S
city: Ballerup
country: Denmark
facility: CCBR A/S
city: Copenhagen NV
country: Denmark
facility: Y Forskning, Bispebjerg Hospital
city: Frederiksberg
country: Denmark
facility: Frederiks Hospital, Kardiologisk
city: Hellerup
country: Denmark
facility: Kolesterollaboratoriet
city: Vejle
country: Denmark
facility: CCBR A/S
city: Breda
country: Netherlands
facility: Middellaan 5
city: Eindhoven
country: Netherlands
facility: Bomanshof 8
city: Groningen
country: Netherlands
facility: Damsterdiep 9
city: Leiden
country: Netherlands
facility: Doezastraat 1
city: Nijmegen
country: Netherlands
facility: Kamerlingh Onnesstraat 16-18
city: Rotterdam
country: Netherlands
facility: Mathenesserlaan 247
city: Velp
country: Netherlands
facility: Reigerstraat 30
city: Zoetermeer
country: Netherlands
facility: Parkdreef 142
city: San Juan
country: Spain
facility: Hospital Clinico S. Juan de Alicante
state: Alicante
city: Villaroel
country: Spain
facility: Hospital Clinic i Provincial
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Valencia
country: Spain
facility: Hospital de Sagunto
city: Angelhom
country: Sweden
facility: Angelholms Sjukhus, Medicinkliniken
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Intermedicin
city: Helsingborg
country: Sweden
facility: Hjartmottagningen
city: Karineholm
country: Sweden
facility: Lakarcentrum Nyponet
city: Ludvika
country: Sweden
facility: Medicinkliniken
city: Malmo
country: Sweden
facility: Hjartmottagningen
city: Sandviken
country: Sweden
facility: Huslakaren i Sandviken
city: Sandviken
country: Sweden
facility: Narsjukhuset Sandviken, Kardiologlab, Medicin
city: Sodertalje
country: Sweden
facility: Hjart & Karlcenter
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Varberg
country: Sweden
facility: Hjarthuset AB
Study officials:
affiliation: Medical Director
name: Dragos Budinski, Med Dr.
role: STUDY_DIRECTOR
References:
citation: Eriksson M, Budinski D, Hounslow N. Comparative efficacy of pitavastatin and simvastatin in high-risk patients: a randomized controlled trial. Adv Ther. 2011 Sep;28(9):811-23. doi: 10.1007/s12325-011-0056-7. Epub 2011 Aug 25.