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

Phase 3

Completed

• Conditions: Hypercholesterolemia; Dyslipidemia; Coronary Heart Disease
• Interventions: Drug: pitavastatin; Drug: simvastatin

• Registration Number: NCT00344175
• Lead Sponsor: Kowa Research Europe

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-22
• Study First Submitted QC: 2006-06-23
• Study First Posted: 2006-06-26
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Results First Submitted: 2009-09-01
• Results First Submitted QC: 2009-12-11
• Status Verified: 2010-01
• Results First Posted: 2010-01-18
• Last Update Submitted: 2010-01-25
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

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

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Exclusion Criteria

• Withdrawn or terminated from NK-104-304 (00309738)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin 4 mg	pitavastatin	Pitavastatin 4 mg once daily
Simvastatin 40mg/80mg	simvastatin	Simvastatin 40 mg or 80 mg once daily

Primary Outcome Measures

Name	Time	Method
Number of Patients Attaining NCEP LDL-C Target at Week 16	16 weeks	Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL.
Number of Patients Attaining NCEP LDL-C Target at Week 44	44 Weeks	Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in LDL-C	Baseline to 44 weeks

Trial Locations

Locations (28)

Huslakaren i Sandviken; 🇸🇪 Sandviken, Sweden

Hjarthuset AB; 🇸🇪 Varberg, Sweden

Kamerlingh Onnesstraat 16-18; 🇳🇱 Nijmegen, Netherlands

Hospital Clinico S. Juan de Alicante; 🇪🇸 San Juan, Alicante, Spain

Narsjukhuset Sandviken, Kardiologlab, Medicin; 🇸🇪 Sandviken, Sweden

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain

CCBR A/S; 🇩🇰 Vejle, Denmark

Frederiks Hospital, Kardiologisk; 🇩🇰 Frederiksberg, Denmark

Angelholms Sjukhus, Medicinkliniken; 🇸🇪 Angelhom, Sweden

Y Forskning, Bispebjerg Hospital; 🇩🇰 Copenhagen Nv, Denmark

Middellaan 5; 🇳🇱 Breda, Netherlands

Kolesterollaboratoriet; 🇩🇰 Hellerup, Denmark

Damsterdiep 9; 🇳🇱 Groningen, Netherlands

Bomanshof 8; 🇳🇱 Eindhoven, Netherlands

Doezastraat 1; 🇳🇱 Leiden, Netherlands

Mathenesserlaan 247; 🇳🇱 Rotterdam, Netherlands

Hospital Universitario Reina Sofia; 🇪🇸 Cordoba, Spain

Parkdreef 142; 🇳🇱 Zoetermeer, Netherlands

Reigerstraat 30; 🇳🇱 Velp, Netherlands

Hjartmottagningen; 🇸🇪 Helsingborg, Sweden

Hospital Clinico Universitario de Santiago; 🇪🇸 Santiago de Compostela, Spain

Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Sahlgrenska University Hospital, Intermedicin; 🇸🇪 Gothenburg, Sweden

Lakarcentrum Nyponet; 🇸🇪 Karineholm, Sweden

Medicinkliniken; 🇸🇪 Ludvika, Sweden

Hjart & Karlcenter; 🇸🇪 Sodertalje, Sweden

Karolinska Universitetssjukhuset; 🇸🇪 Stockholm, Sweden

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain