UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025620
Receipt number 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 14:04:46

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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 or person

Institute

Misaki Naika Clinic

Institute

Department

Personal name



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

Value
https://center6.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