UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009955 |
|---|---|
| Receipt number | R000011656 |
| Scientific Title | Effect of statin (Rosuvastatin) on postprandial hypertriglyceridemia |
| Date of disclosure of the study information | 2013/02/04 |
| Last modified on | 2015/03/07 15:04:14 |
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Basic information
Public title
Effect of statin (Rosuvastatin) on postprandial hypertriglyceridemia
Acronym
Effect of statin (Rosuvastatin) on postprandial hypertriglyceridemia
Scientific Title
Effect of statin (Rosuvastatin) on postprandial hypertriglyceridemia
Scientific Title:Acronym
Effect of statin (Rosuvastatin) on postprandial hypertriglyceridemia
Region
| Japan |
Condition
Condition
dyslipidemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we are intending to verify the effect of statin (Rosuvastatin) on lowering postprandial elevation of triglyceride (TG). We conduct Meal Tolerance test, in which we measure serum TG levels at the fasting state and 2 & 4 hours after eating test meal that contains 26.7 grams of total lipid weight, prior to administration of statin and 1 & 3 monts(s) after administeration. This study is targeting to invite about 100 patients with high-LDL cholesterol, who are recommended to administer the statin according to Japanese guideline of dyslipidemia. In addition, we plan to verify correlations between postprandial hypertriglyceridemia and potent arteriosclerosis-inducing lipoproteins such as small, dense-LDL & remnant-like lipoprotein, simultaneously.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
All patients are devided into "more increase in TG" group and "less increase in TG" group, according to the median of the sum total of POST PRANDIAL TG ELEVATION ((TG in 4 hours minus fasting)+ (TG in 2 hours minus fasting)), before administration of statin. Primary outcome of this study is that there will be a significant difference of POST PRALDIAL TG ELEVATION and small, dense-LDL levels at 3 months after administration of statin between two groups. We use Student-T test as statistical analysis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rosuvastatin 2.5 mg is administered to all participating patients. When LDL-C does not lower to desired level 1 month after administration, Rosuvastatin is increased to 5.0 mg. We continue administration of Rosuvastatin after this examination, unless the patient is tolerable.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study is targeting to invite about 100 patients with high-LDL cholesterol, who are recommended to administer the statin according to Japanese guideline of dyslipidemia.
Key exclusion criteria
1) Secondary dyslipidemia, due to hypothyroidism, nephrotic syndrome, Cushing syndrome, and so on.
2) Familial hypercholesterolemia
3) Fasting TG is over 500 mg/dl
4) Renal dysfunction (Creatinin 2.0 mg/dl, or blood ure nitrogen 25 mg/dl)
5) Liver dysfunction (transaminase is more than three times the upper limit of normal)
6) Higher serum level of Creatin kinase (more than three times the upper limit of normal)
7) Pregnant women and women who are suspected to get pregnant
8) Patients who are taking drugs which is contraindication in combination with statin such as Cyclosporine or Fibrates
9) Patients who have a history of adverse effect of statins.
10) Patients who are judged ineligible
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Hatano, MD. |
Organization
The University of Tokyo Hospital
Division name
Cardiology
Zip code
Address
7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL
03-3815-5411
hatanoma@pg8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironori Muraoka, MD. |
Organization
The University of Tokyo Hospital
Division name
Cardiology
Zip code
Address
7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
muraoka@nms.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
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
| 2013 | Year | 02 | Month | 04 | 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
| 2012 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 04 | Day |
Last modified on
| 2015 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011656
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