UMIN-CTR Clinical Trial

Public title

Comparison of effects of azilsartan and olmesartan in paitents with type 2 diabetes mellitus with hypertension: A crossover trial.

Acronym

Comparison of azilsaratan and olmesartan

Scientific Title

Comparison of effects of azilsartan and olmesartan in paitents with type 2 diabetes mellitus with hypertension: A crossover trial.

Scientific Title:Acronym

Comparison of azilsaratan and olmesartan

Region

Japan

Condition

Patients with type 2 diabetes mellitus with hypertension

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study was to compare the effects of azilsartan and olmesartan on blood pressure in patients with type 2 diabetes melliutus and hypertension

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Office blood pressure

Key secondary outcomes

24hour blood pressure,daytime blood pressure,night time blood pressure(ABPM at 16,48weeks),HbA1c, FBG, IRI, urinary microalbumin, glucosylated albumin, hs-CRP, adiponectin, L-FABP, pentraxin3

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

After completion of valsaltan 80 mg/day run in the period, the participants were randomized into one of two treatment groups; the 20 mg/day azilsartan group (A group) instead of valsaltan. After 16 weeks of azilsartan , the subjects in A group were switched to valsartan 80mg/day in the washout period for 16 weeks. subject in the A group were switched to olmesrtan 20mg/day.A group continued the treatment for 16 week

Interventions/Control_2

After completion of valsaltan 80 mg/day run in the period, the participants were randomized into one of two treatment groups; the 20 mg/day olmesartan (O group) instead of valsaltan. After 16 weeks of olmesrtan treatment, the subjects in O group were switched to valsartan 80mg/day in the washout period for 16 weeks. subject in the O group were switched to asilsartan 20mg/day. O group continued the treatment for 16 week

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Type 2 Diabetes mellitus 2)Hypertension (130/80mmHg)
3)Patients treated with varsartan 80mg/day

Key exclusion criteria

1)Pregnant, lactating, and possibly pregnant women
2)severe liver disease
3)severe kidney disease(s-Cr 2.0mg/dl and mora)
4) Treatment with insurin
5) patients who have allergy to the medicine used in this study
6)Patients attending physician has determined is inappropriate for research participation
7)Patients who do not obtain written consent

Target sample size

38

Name of lead principal investigator

1st name
Middle name
Last name	Watada, Hirotaka

Organization

Juntendo University Faculty of Medicine

Division name

Department of metabolism and endocrinology

Zip code

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

Chiken@juntendo.ac.jp

Name of contact person

1st name
Middle name
Last name	Masaki Miura

Organization

Juntendo University Faculty of Medicine

Division name

Department of metabolism and endocrinology

Zip code

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

0338133111

Homepage URL

Email

Chiken@juntendo.ac.jp

Institute

Juntendo University Graduate School of Medicine,Department of Metabolism & Endocrinology

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

12

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2013

Year

11

Month

19

Day

Date of IRB

Anticipated trial start date

2013

Year

12

Month

18

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

12

Month

18

Day

Last modified on

2013

Year

12

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014753