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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018599
Receipt No. R000021526
Scientific Title Effect of ezetimibe on PCSK9 concentrations in patients with type 2 diabetes and dyslipidemia
Date of disclosure of the study information 2015/08/08
Last modified on 2016/03/08

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Basic information
Public title Effect of ezetimibe on PCSK9 concentrations in patients with type 2 diabetes and dyslipidemia
Acronym Effect of ezetimibe on PCSK9 concentrations in patients with type 2 diabetes and dyslipidemia
Scientific Title Effect of ezetimibe on PCSK9 concentrations in patients with type 2 diabetes and dyslipidemia
Scientific Title:Acronym Effect of ezetimibe on PCSK9 concentrations in patients with type 2 diabetes and dyslipidemia
Region
Japan

Condition
Condition Hypercholesterolemia
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study evaluated the effect of ezetimibe monotherapy or in combination with a statin on serum levels of PCSK9 in patients with type 2 diabetes and hypercholesterolemia.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in PCSK9 concentration after ezetimibe treatment
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 ezetimibe, 10mg/day after breakfast,for 6 months
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 type 2 diabetes mellitus and hypercholesterolemia
Key exclusion criteria 1)TG>400mg/dl
2)use of insulin
3)pregnant
4)allergy agignst treatment drug
5)severe liver disease
6)severe kideny disease
7)history of myocardial infarction or unstable angina within 3 months
8)secondary hyperlimidemia, drug-induced hyperlimidemia, familial hypercholeaterolemia
9)use of ezetimib or fibrate
10)subject who is not suitable for this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Miyoshi
Organization Okayama University Hospital
Division name Cardiovascular Medicine
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7351
Email miyoshit@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Miyoshi
Organization Okayama University Hospital
Division name Cardiovascular Medicine
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7351
Homepage URL
Email miyoshit@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital, Depertment of Cardiovascular Medicine
Institute
Department

Funding Source
Organization Okayama University Hospital, Depertment of Cardiovascular Medicine
Organization
Division
Category of Funding Organization Other
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
2015 Year 08 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 08 Day
Last modified on
2016 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021526

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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