UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003628 |
|---|---|
| Receipt number | R000004399 |
| Scientific Title | Toyama Anti-arteriosclerosis and Plaque Assessment Trial by Aggressive Lipid Lowering Therapy with Pitavastatin in Peripheral Artery Disease |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2010/05/17 18:20:22 |
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Basic information
Public title
Toyama Anti-arteriosclerosis and Plaque Assessment Trial by Aggressive Lipid Lowering Therapy with Pitavastatin in Peripheral Artery Disease
Acronym
TULIP
Scientific Title
Toyama Anti-arteriosclerosis and Plaque Assessment Trial by Aggressive Lipid Lowering Therapy with Pitavastatin in Peripheral Artery Disease
Scientific Title:Acronym
TULIP
Region
| Japan |
Condition
Condition
Patients with peripheral artery disease and hypercholesterolemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of intensive with conventional lipid lowering therapy, on patients with peripheral artery disease and hypercholesterolemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
claudication time on Treadmill exercise test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intensive lipid lowering therapy with Pitavastatin, 1 to 4mg once daily, to achieve serum LDL cholesterol level less than 80mg/dl.
Interventions/Control_2
conventional lipid lowering therapy with Pitavastatin, 1 to 4mg once daily, to achieve serum LDL cholesterol level less than 120mg/dl in patients without coronary heart disease or less than 100mg/dl in patients with coronary heart disease.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patient without coronary artery disease, whose LDL cholesterol >= 120mg/dl
2) Patient with coronary artery disease, whose LDL cholesterol >= 100mg/dl
3) Ankle Brachial Pressure Index (ABI) <= 0.9
Key exclusion criteria
1) Following "contraindication" or "essentially contraindication" of pitavastatin as follows:
severe liver injury or biliary obstruction
patients taking cyclosporin
pregnant or possible pregnant women or
breast-feeding women
patients with renal dysfunction and taking fibrates
2) patients already taking pitavastatin
3) patients with maintenance dialysis
4) patients who plan to undergo or underwent bilateral lower limb revascularization within within 3 months.
5) patients with severe peripheral artery disease (Fontaine classification class 4)
6) patient with previous cerebral hemorrhage
7) patients who judged inadequate by the co-execution doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Inoue |
Organization
University of Toyama
Division name
Graduate school of medicine and pharmaceutical science, The Second Department of Internal Medicine
Zip code
Address
2630 Sugitani, Toyama
TEL
076-434-7297
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoki Kameyama |
Organization
University of Toyama
Division name
Graduate school of medicine and pharmaceutical science, The Second Department of Internal Medicine
Zip code
Address
2630 Sugitani, Toyama
TEL
076-434-7297
Homepage URL
Sponsor or person
Institute
The Second Department of Internal Medicine, University of Toyama, Graduate school of medicine and pharmaceutical science,
Institute
Department
Personal name
Funding Source
Organization
The Second Department of Internal Medicine, University of Toyama, Graduate school of medicine and pharmaceutical science,
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 17 | Day |
Last modified on
| 2010 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004399
| Research Plan | |
|---|---|
| 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 |
