Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

Phase 3

Completed

• Conditions: Hypercholesterolemia; Dyslipidemia
• Interventions: Drug: Pitavastatin

• Registration Number: NCT00325780
• Lead Sponsor: Kowa Research Europe

Brief Summary

This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU.

Detailed Description

Patients from the NK-104-3.01EU and NK-104-3.02EU studies will continue to receive either pitavastatin or the comparator statin for 1 year.

Study Timeline

• Study First Submitted: 2006-02-10
• Study First Submitted QC: 2006-05-11
• Study First Posted: 2006-05-15
• Study Start: 2006-07
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2009-08-26
• 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: 1355

Inclusion Criteria

• Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) or NK-104-302 (NCT00309777)
• Patients who have not developed any treatment emergent and, in the opinion of the investigator, related adverse event (AE) of clinical significance where the investigator is uncomfortable with continuing the patient on therapy with pitavastatin.
• Patients who have been following a fat and cholesterol restrictive diet.

Exclusion Criteria

• Any conditions which may cause secondary dyslipidemia should be reassessed at the beginning of the follow-up study.
• Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-up study.
• Abnormal pancreatic, liver, or renal function
• Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above the pre-specified level
• Significant heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pitavastatin 4 mg QD	Pitavastatin	Pitavastatin 4 mg once daily

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)	Baseline to 52 Weeks	Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Total Cholesterol	Baseline to 52 weeks	Mean percent change from baseline in total cholesterol

Trial Locations

Locations (186)

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

Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark

Medical Center; 🇩🇰 Copenhagen, Denmark

Frederiks Hospital, Kardiologisk; 🇩🇰 Frederiksberg, Denmark

Kolesterollaboratoriet; 🇩🇰 Hellerup, Denmark

CCBR A/S; 🇩🇰 Vejle, Denmark

Geri-Med Oy; 🇫🇮 Helsinki, Finland

Kaisaniemen Laakariasema; 🇫🇮 Helsinki, Finland

Keravan Laakarikeskus; 🇫🇮 Helsinki, Finland

SOK-Tyoterveyshuolto; 🇫🇮 Tampere, Finland

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