Clinical trial NCT00344175: Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors
Official title: Double-blind follow-on Study of Pitavastatin (4mg) Versus Simvastatin (40mg and 80mg) With a Single-blind Extension of Treatment 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
Coronary Heart Disease
Keywords: hypercholesterolemia
dyslipidemia
CHD
pitavastatin
simvastatin
2 or more risk factors for coronary heart disease
combined dyslipidemia
Lead sponsor: Kowa Research Europe
Sponsor class: INDUSTRY
First posted: 2006-06-26
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.

Detailed description: This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.

Eligibility criteria: Inclusion Criteria:

* Completed NK-104-304 (NCT 00309738)
* Hypercholesterolemia or combined dyslipidemia
* 2 or more risk factors for coronary heart disease (CHD)

Exclusion Criteria:

* Withdrawn or terminated from NK-104-304 (00309738)

Primary outcomes:
measure: Number of Patients Attaining NCEP LDL-C Target at Week 16
timeFrame: 16 weeks
measure: Number of Patients Attaining NCEP LDL-C Target at Week 44
timeFrame: 44 Weeks
Secondary outcomes:
measure: Percent Change From Baseline in LDL-C
timeFrame: Baseline to 44 weeks
Other outcomes:
Locations:
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: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
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: 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: Kowa Research Europe
name: Dragos Budinski, MD
role: STUDY_DIRECTOR
References:
citation: Eriksson M, Budinski D, Hounslow N. Long-term efficacy of pitavastatin versus simvastatin. Adv Ther. 2011 Sep;28(9):799-810. doi: 10.1007/s12325-011-0057-6. Epub 2011 Aug 25.