Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344175
• Other study ID #: NK-104-309
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2006
• Last updated: January 25, 2010
• Start date: June 2006
• Est. completion date: August 2007

Study information

• Verified date: January 2010
• Source: Kowa Research Europe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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• Withdrawn or terminated from NK-104-304 (00309738)

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

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Dyslipidemia
• Dyslipidemias
• Heart Diseases
• Hypercholesterolemia
• Myocardial Ischemia

Intervention

Drug:
• pitavastatin

• simvastatin

Locations

Country	Name	City	State
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 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
Sweden	Angelholms Sjukhus, Medicinkliniken	Angelhom
Sweden	Sahlgrenska University Hospital, Intermedicin	Gothenburg
Sweden	Hjartmottagningen	Helsingborg
Sweden	Lakarcentrum Nyponet	Karineholm
Sweden	Medicinkliniken	Ludvika
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	Number of Patients Attaining NCEP LDL-C Target at Week 16		16 weeks	No
Primary	Number of Patients Attaining NCEP LDL-C Target at Week 44		44 Weeks	No
Secondary	Percent Change From Baseline in LDL-C		Baseline to 44 weeks	No