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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001130
Receipt No. R000001377
Scientific Title Pitavastatin or bezafibrate intervention, assessment of antiarteriosclerotic effect (PIONEER)
Date of disclosure of the study information 2008/08/01
Last modified on 2014/05/13

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Basic information
Public title Pitavastatin or bezafibrate intervention, assessment of antiarteriosclerotic effect (PIONEER)
Acronym Pitavastatin or bezafibrate intervention, assessment of antiarteriosclerotic effect (PIONEER)
Scientific Title Pitavastatin or bezafibrate intervention, assessment of antiarteriosclerotic effect (PIONEER)
Scientific Title:Acronym Pitavastatin or bezafibrate intervention, assessment of antiarteriosclerotic effect (PIONEER)
Region
Japan

Condition
Condition Type 2b hyperlipidemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of lipid-lowering therapy with pitavastatin or bezafibrate on intima-media thickness (IMT) of carotid artery in patients with type 2b hyperlipidemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes An absolute change of intima-media thickness (IMT) of common carotid artery
Key secondary outcomes 1) A percent change of serum lipids and apolipoproteins (LDL-C, HDL-C, triglyceride, remnant lipoprotein-C, apoB48)
2) A percent change of serum lipoprotein fractionation
3) A percent change of high sensitive C-reactive protein (hs-CRP)
4) A percent change of adiponectin
5) Relationship between the absolute change in of intima-media thickness (IMT) of common carotid artery and percent change of each marker
6) Change in surface morphology and plaque tissue characterization

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pitavastatin 2 mg daily for a period of 12 months
Interventions/Control_2 Bezafibrate 400 mg daily for a period of 12 months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients whose LDL-cholesterol level is 140-179 mg/dL (If no measured values are available, values calculated by Friedewald's formula) and Triglyceride level is 150-399 mg/dL
2) Patients who have been diagnosed at least with one of following disease that a history of acute coronary syndrome, a history of cerebral infarction, arteriosclerosis obliterans, diabetes mellitus, and hypertension
3) Patients who are at age of 40 or over and less than 80 years at time of consent
4) Patients giving written consent by their own volition after being provided sufficient explanation for participation in this clinical trial
Key exclusion criteria 1) Contraindication of Livalo Tab (pitavastatin calcium)
- Patients with a history of hypersensitivity to any of the conponents of the product
- Patients with severe hepatic disorder or biliary atresia
- Patients receiving cyclosporine
- Pregnant women, women suspected of being pregnant, or lactating women
2) Contraindication of Bezator SR tab (bezafibrate)
- Patients with renal dialysis
- Patients with significant renal disease like renal failure
- Patients with serum creatinine >/= 2.0 mg/dL
- Patients with history of hypersensitivity to any of the ingredients of the product
- Pregnant women, women suspected of being pregnant, or lactating women
3) Patients with hepatic disorders (ALT or AST >/= 100IU/L)
4) Patients with HbA1c >/= 9.0%
5) Patients with obvious steonosis in carotid artery
6) Patients who are being treated with insulin
7) Patients whom the principle investigators or other investigators consider unsuitable
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shizuya Yamashita
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3732
Email shizu@cardiology.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shizuya Yamashita
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL 06-6879-3732
Homepage URL
Email shizu@cardiology.med.osaka-u.ac.jp

Sponsor
Institute The Research group for Arteriosclerosis treatment of The supporting Center for Clinical Research and Education : SCCRE, a nonprofit organization
Institute
Department

Funding Source
Organization The Research group for Arteriosclerosis treatment of The supporting Center for Clinical Research and Education : SCCRE, a nonprofit organization
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 04 Month 24 Day
Last modified on
2014 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001377

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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