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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009955
Receipt No. 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

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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
Email 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
Email muraoka@nms.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011656

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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