UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001130 |
|---|---|
| Receipt number | 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 17:48:04 |
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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
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
shizu@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
The Research group for Arteriosclerosis treatment of The supporting Center for Clinical Research and Education : SCCRE, a nonprofit organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001377
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
