UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012619 |
|---|---|
| Receipt number | R000014753 |
| Scientific Title | Comparison of effects of azilsartan and olmesartan in paitents with type 2 diabetes mellitus with hypertension: A crossover trial. |
| Date of disclosure of the study information | 2013/12/18 |
| Last modified on | 2013/12/18 17:43:55 |
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Basic information
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
Condition
Patients with type 2 diabetes mellitus with hypertension
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
Chiken@juntendo.ac.jp
Public contact
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
Chiken@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine,Department of Metabolism & Endocrinology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2013 | Year | 12 | Month | 18 | 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
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
Other related information
Management 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
