UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002965 |
|---|---|
| Receipt number | R000003444 |
| Scientific Title | Prospective, randomized, open-label, clinical trial comparing statin monotherapy and statin-fibrate combination therapy in patients with elevated triglycerides and LDL-cholesterol on progression of atherosclerotic plaques, endothelial function, and markers for anti-inflammatory properties/obesity/antioxidative properties |
| Date of disclosure of the study information | 2010/01/03 |
| Last modified on | 2018/05/24 14:20:50 |
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Basic information
Public title
Prospective, randomized, open-label, clinical trial comparing statin monotherapy and statin-fibrate combination therapy in patients with elevated triglycerides and LDL-cholesterol on progression of atherosclerotic plaques, endothelial function, and markers for anti-inflammatory properties/obesity/antioxidative properties
Acronym
Prospective, randomized, open-label, clinical trial comparing statin monotherapy and statin-fibrate combination therapy
Scientific Title
Prospective, randomized, open-label, clinical trial comparing statin monotherapy and statin-fibrate combination therapy in patients with elevated triglycerides and LDL-cholesterol on progression of atherosclerotic plaques, endothelial function, and markers for anti-inflammatory properties/obesity/antioxidative properties
Scientific Title:Acronym
Prospective, randomized, open-label, clinical trial comparing statin monotherapy and statin-fibrate combination therapy
Region
| Japan |
Condition
Condition
dyslipidemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of statin monotherapy and statin-fibrate combination therapy on progression of atherosclerotic plaques, endothelial function, and markers for anti-inflammatory properties/obesity/antioxidative properties
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization
Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6/12/24 months after randomization
Flow-mediated vasodilation in forearm, 6 months after randomization
Heparin-releasable EC-SOD levels, 6 months after randomization
Key secondary outcomes
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6/12/24 months after randomization
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of fenofibrate
Interventions/Control_2
No medication
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
| 20 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Hypertriglyceridemic patients (TG>150mg/dl) under treatment with statins
2) Patients who have aortic atherosclerotic plaques detected by MRI
3) Outpatients
4) Subjects who gave written informed consent
Key exclusion criteria
1) Allergy against fenofibrate
2) Poor-controlled hypertension (DBP>110 mmHg)
3) Poor-controlled diabetes (HbA1c>9.0 %)
4) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
5) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits.
6) Chronic renal failure (serum creatinine>2.0 mg/dl)
7) Malignancies or other diseases with poor prognosis
8) Pregnant
9) Subjects whose doctor in charge do not agree to join the trial
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsunori Ikewaki |
Organization
National Defense Medical College
Division name
Department of Internal Medicine I
Zip code
Address
3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL
04-2995-1597
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ayaori |
Organization
National Defense Medical College
Division name
Department of Internal Medicine I
Zip code
Address
3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL
04-2995-1597
Homepage URL
ayaori@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Defense Medicine
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
防衛医科大学校
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 02 | Day |
Last modified on
| 2018 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003444
