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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025620
Receipt No. R000029476
Scientific Title A comparative clinical trial on the effects of atorvastatin 10mg and atorvastatin 5mg/ ezetimibe 10mg in type 2 diabetic patients with nephropathy and hypercholesterolemia
Date of disclosure of the study information 2017/01/13
Last modified on 2017/01/11

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Basic information
Public title A comparative clinical trial on the effects of atorvastatin 10mg and atorvastatin 5mg/ ezetimibe 10mg in type 2 diabetic patients with nephropathy and hypercholesterolemia
Acronym Comparison of the effects of atorvastatin high dose and atorvastatin/ezetimibe combination therapy
Scientific Title A comparative clinical trial on the effects of atorvastatin 10mg and atorvastatin 5mg/ ezetimibe 10mg in type 2 diabetic patients with nephropathy and hypercholesterolemia
Scientific Title:Acronym Comparison of the effects of atorvastatin high dose and atorvastatin/ezetimibe combination therapy
Region
Japan

Condition
Condition Type 2 diabetic patients with nephropathy and hypercholesterolemia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of the effects of atorvastatin 10mg and atorvastatin 5mg/ezetimibe10mg on lipid profile, renal function and safety in type 2 diabetic patients with nephropathy and hypercholesterolemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in non-HDL cholesterol at 12 weeks after administration
Key secondary outcomes Change in lipid profile (TC, LDL-C, HDL-C, TG, RLP), parameters related to renal function (urine albuminm, urine collagen IV, L-FABP), parameters related to glucose metabolism (fasting glucose, HbA1c), and safety at 12 weeks after administration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Each subject will orally receive atorvastatin 10mg once daily for 3 months.
Interventions/Control_2 Each subject will orally receive atorvastatin 5mg and ezetimibe 10mg once daily for 3 months.
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 1) During of atorvastatin (5mg once daily) treatment more than 3 months
2) LDL-C>=100mg/dL
3) CKD stage G3a and G3b (30<=eGFR<60)
4) Age>=20 years old
5) No change in medication of lipid-lowering and antidiabetic drug within 12 weeks
6) 6.5%<=HbA1c<=8% (NGSP)
7) Patients with written IC
Key exclusion criteria 1) Patients with hypersensitivity of the test drugs
2) Patients with hepatic dysfunction(AST or ALT>=100U)
3) Patients with a past history of cerebrovascular or cardiovascular event
4) Patients with secondary or drug-induced hyperlipidemia
5) Patients with familial hypercholesterolemia
6) Pregnant or possibly pregnant patients, patients on lactation
7) Patients with insulin treatment
8) Patients with fibrate treatment
9) Inappropriate patients for this study according to the judgment of Investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuichi Kuribayashi
Organization Misaki Naika Clinic
Division name Internal medicine
Zip code
Address 6-44-9, Futawa-higashi, Funabashi city, Chiba
TEL 047-440-2222
Email n-kuribayashi@am.wakwak.com

Public contact
Name of contact person
1st name
Middle name
Last name Nobuichi Kuribayashi
Organization Misaki Naika Clinic
Division name Internal medicine
Zip code
Address 6-44-9, Futawa-higashi, Funabashi city, Chiba
TEL 047-440-2222
Homepage URL
Email n-kuribayashi@am.wakwak.com

Sponsor
Institute Misaki Naika Clinic
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 三咲内科クリニック

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 13 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
Compared with the atorvastatin group, the rate of reduction of non HDL-C and LDL-C was significantly larger in the ezetimibe group. Renal marker and safety did not differ between the two groups.
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
2013 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2015 Year 11 Month 30 Day
Date of closure to data entry
2016 Year 01 Month 14 Day
Date trial data considered complete
2016 Year 02 Month 22 Day
Date analysis concluded
2016 Year 03 Month 25 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 11 Day
Last modified on
2017 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029476

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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