MedDataX Logo

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

NCT ID: NCT00309777

Last Updated: 2010-01-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

857 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

NCT00309738

Hypercholesterolemia Dyslipidemia
COMPLETED PHASE3

Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

NCT00309751

Type II Diabetes Mellitus Dyslipidemia
COMPLETED PHASE3

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

NCT00344175

Hypercholesterolemia Dyslipidemia Coronary Heart Disease
COMPLETED PHASE3

Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia

NCT00330876

Hypercholesterolemia Dyslipidemias
COMPLETED PHASE3

Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients

NCT00257686

Hypercholesterolemia or Combined Dyslipidemia
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia Dyslipidemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pitavastatin 2 mg

Pitavastatin 2 mg once daily

Group Type EXPERIMENTAL

Pitavastatin

Intervention Type DRUG

Pitavastatin once daily

Simvastatin 20 mg

Simvastatin 20 mg once daily

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Simvastatin once daily

Pitavastatin 4 mg

Pitavastatin 4 mg once daily

Group Type EXPERIMENTAL

Pitavastatin

Intervention Type DRUG

Pitavastatin once daily

Simvastatin 40 mg

Simvastatn 40 mg once daily

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Simvastatin once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pitavastatin

Pitavastatin once daily

Intervention Type DRUG

Simvastatin

Simvastatin once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males and females (18-75 years)
* Must have been following a restrictive diet
* Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria

* Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
* Conditions which may cause secondary dyslipidemia.
* Uncontrolled diabetes mellitus (by hemoglobin A1c \[HbA1c\] \> 8%)
* Abnormal serum creatine kinase (CK) above the pre-specified level
* Abnormal pancreatic, liver or renal function
* Significant heart disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kowa Research Europe

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kowa Research Europe, Ltd.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dragos Budinski, Med Dr.

Role: STUDY_DIRECTOR

Medical Director

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Geri-Med Oy

Helsinki, , Finland

Site Status

Kaisaniemen Laakariasema

Helsinki, , Finland

Site Status

Keravan Laakarikeskus

Helsinki, , Finland

Site Status

SOK-tyoterveyshuolto

Tampere, , Finland

Site Status

TYKS University Hospital

Turku, , Finland

Site Status

Dipartimento Di Medicina Clinica e Biotecnologia Applicata

Bologna, , Italy

Site Status

Centro di Ricerca Clinica

Chieti, , Italy

Site Status

Gerontologia e Geriatria - Universita degli Studi

Ferrara, , Italy

Site Status

Dipartimento di Medicina Interna DIMI

Genova, , Italy

Site Status

Universita di Modena e Reggio Emilia, Policlinico

Modena, , Italy

Site Status

Dipartimento di Medicina Clinica e Sperimentale

Napoli, , Italy

Site Status

Medicina Clinica e delle Patologie Emergenti

Palermo, , Italy

Site Status

Dipartimento di Medicina Interna e Scienze Biomediche

Parma, , Italy

Site Status

U.O Malattie Metaboliche e Diabetologia

Treviglio, , Italy

Site Status

Azienda Ospedaliero-Universitaria

Trieste, , Italy

Site Status

Volvat Medisinske Senter

Fredrikstad, , Norway

Site Status

Nyomen Legekontor

Kongsberg, , Norway

Site Status

Radhuset Spesialistsenter

Oslo, , Norway

Site Status

Rikshospitalet - University Hospital

Oslo, , Norway

Site Status

Skedsmo Medisinske Senter A.S.

Skedsmokorset, , Norway

Site Status

Kemerovo Cardiology Dispensary

Kemerovo, , Russia

Site Status

Central Clinical Hospital 1 of RZD

Moscow, , Russia

Site Status

City Clinical Hospital 23

Moscow, , Russia

Site Status

City Clinical Hospital 64

Moscow, , Russia

Site Status

Moscow City Clinical Hospital 68

Moscow, , Russia

Site Status

State Research Center for Preventive Medicine

Moscow, , Russia

Site Status

Novosibirsk Reg. Clinical Cardiology Dispensary

Novosibirsk, , Russia

Site Status

Central Medical Unit 122, St. Pb

Saint Petersburg, , Russia

Site Status

Clinical Hospital of Russian Academy of Sciences

Saint Petersburg, , Russia

Site Status

Consulting and Diagnostic Center 85

Saint Petersburg, , Russia

Site Status

Krestovsky Island Medical Institute

Saint Petersburg, , Russia

Site Status

Pokrovskaya City Hospital

Saint Petersburg, , Russia

Site Status

St Michael's Partnership

Bath, , United Kingdom

Site Status

Avondale Surgery

Chesterfield, , United Kingdom

Site Status

Knowle House Surgery

Plymouth, , United Kingdom

Site Status

The Burngreave Surgery

Sheffield, , United Kingdom

Site Status

St Helier Hospital

Surrey, , United Kingdom

Site Status

Box Surgery

Wiltshire, , United Kingdom

Site Status

Eastleigh Surgery

Wiltshire, , United Kingdom

Site Status

Lovemead Group Practice

Wiltshire, , United Kingdom

Site Status

St Chad's Surgery

Wiltshire, , United Kingdom

Site Status

The Health Centre

Wiltshire, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland Italy Norway Russia United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia. Curr Med Res Opin. 2009 Nov;25(11):2755-64. doi: 10.1185/03007990903290886.

Reference Type DERIVED
PMID: 19785568 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT number 2005-001033-15

Identifier Type: -

Identifier Source: secondary_id

NK-104-302

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
NCT00325780 COMPLETED PHASE3
Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels
NCT00249249 COMPLETED PHASE3
Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia
NCT01710007 COMPLETED PHASE3
Follow-On Study of Pitavastatin Versus Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
NCT00344370 COMPLETED PHASE3
Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
NCT00889226 COMPLETED PHASE4
A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia
NCT03618797 COMPLETED PHASE3
To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia
NCT04584736 COMPLETED PHASE3
Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia
NCT01166633 COMPLETED PHASE4
Efficacy And Safety Study Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia
NCT00141141 COMPLETED PHASE4
Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03757)(COMPLETED)
NCT00650819 COMPLETED PHASE3
Ezetimibe Plus Simvastatin Versus Simvastatin in Patients With Hypercholesterolemia and Coronary Risk Factors (P03405)
NCT00651014 TERMINATED PHASE4
Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
NCT00349375 COMPLETED PHASE3
Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
NCT01256476 COMPLETED PHASE4
Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)
NCT00651274 COMPLETED PHASE4
Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)
NCT00861861 COMPLETED PHASE4
A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia
NCT05930028 COMPLETED PHASE3
A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease
NCT01674712 COMPLETED PHASE3
The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)
NCT00423579 COMPLETED PHASE4
Safety and Efficacy Study of JTT-705 in Combination With Simvastatin 40 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
NCT00688558 COMPLETED PHASE2
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
NCT07083206 RECRUITING
Efficacy of Lapaquistat Acetate and Simvastatin in Subjects With Primary Dyslipidemia.
NCT00256178 COMPLETED PHASE3
Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin
NCT00362206 COMPLETED PHASE3
Efficacy and Safety Study of Pitavastatin and Atorvastatin in High Risk Hypercholesterolemic Patients
NCT01386853 UNKNOWN PHASE3
Retrospective Survey Evaluating the Effectiveness and Safety of Dual Inhibition Lipid-lowering in the Treatment of Dyslipidemia (Study P05171)(COMPLETED)
NCT00726856 COMPLETED
Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia
NCT00686010 COMPLETED PHASE2