UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016112 |
|---|---|
| Receipt number | R000018718 |
| Scientific Title | Effect of ezetimibe on PCSK9 concentrations in patients with type 2 diabetes and hypercholesterolemia |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2016/03/08 11:56:44 |
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Basic information
Public title
Effect of ezetimibe on PCSK9 concentrations in patients with type 2 diabetes and hypercholesterolemia
Acronym
Effect of ezetimibe on PCSK9 concentrations in patients with type 2 diabetes and hypercholesterolemia
Scientific Title
Effect of ezetimibe on PCSK9 concentrations in patients with type 2 diabetes and hypercholesterolemia
Scientific Title:Acronym
Effect of ezetimibe on PCSK9 concentrations in patients with type 2 diabetes and hypercholesterolemia
Region
| Japan |
Condition
Condition
Dyslipidemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the infuluence of ezetimibe on PCSK9 concentrations in patients with type 2 diabetes and dyslipidemia
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in PCSK9 concentration
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 treatment in patients with or without statin therapy
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
Patients with type 2 diabetes and hypercholesterolemia with or without statin therapy
Key exclusion criteria
1) Triglyceride over 400mg/dl
2) Patients receiving insulin
3) Pregnant
4) Subjects who is allergic to ezetimibe
5) Severe liver disease
6) Serum creatinine over 2 mg/dl
7) Patients with acute myocardial infarction, unstable angina, or stroke within 3 months
8) Secondary hypercholesterolemia, familial hypercholesterolemia
9) Patients receiving ezetimibe or fibrates
10) Unsuitable patients for this study by physicians decision
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
miyoshit@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1 Shikada-cho Kita-ku Okayama
TEL
086-235-7351
Homepage URL
miyoshit@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Okayama University, Department 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
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
| 2017 | Year | 03 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | 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
| 2015 | Year | 01 | Month | 05 | Day |
Last modified on
| 2016 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018718
