UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010604 |
|---|---|
| Receipt number | R000012398 |
| Scientific Title | Efficacy and safety of treatment with Azilsartan in type 2 diabetes mellitus patients with hypertension who did not show target blood pressure by telmisartan. |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2015/04/28 06:52:33 |
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Basic information
Public title
Efficacy and safety of treatment with Azilsartan in type 2 diabetes mellitus patients with hypertension who did not show target blood pressure by telmisartan.
Acronym
Study of Switching to Azilsartan from Telmisartan in type 2 diabetes mellitus patients
Scientific Title
Efficacy and safety of treatment with Azilsartan in type 2 diabetes mellitus patients with hypertension who did not show target blood pressure by telmisartan.
Scientific Title:Acronym
Study of Switching to Azilsartan from Telmisartan in type 2 diabetes mellitus patients
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus with hypertension
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examinate efficacy and safty of treatment with Azilsartan in type 2 diabetes mellitus patients who did not show target blood pressure by Telmisartan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
blood pressure and HbA1c at 0, 4, 8, and 12 weeks after starting of treatment
Key secondary outcomes
AST, ALT, gamma-GTP, LDL, HDL, TG, fasting glucose, adiponectin, safty at 0, 4, 8, and 12 weeks after starting of treatment
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
switching to Azilsartan
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
All patients with type 2 diabetes mellitus with hypertension vistited our Hospital and approved with this study.
They who were being treated with telmisartan 40mg at least for 8 weeks did not reached aim of decrease of blood pressure.
Medication other than antihypertensive drug was not changed for 8weeks.
Key exclusion criteria
1)patients who wrere poorly controlled .
2)patients with secondary hypertension.
3)patients on HD.
4)pregnant patients.
5)patients who wrere allergic to telmisartan.
6)patients with heavy liver dysfunction.
7)patients with heavy renal dysfunction(Cre>3mg/dL).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Iwasaki |
Organization
Iwasaki Naika Clinic
Division name
Internal medicien
Zip code
Address
1-1-5-1F Kamihoshikawa, Hodogaya-ku, Yokohama
TEL
045-442-6475
toiwasaki-dm@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoko Ono |
Organization
Iwasaki Naika Clinic
Division name
Internal medicien
Zip code
Address
1-1-5-1F Kamihoshikawa, Hodogaya-ku, Yokohama
TEL
045-442-6475
Homepage URL
toiwasaki-dm@umin.ac.jp
Sponsor or person
Institute
Iwasaki Naika Clinic
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
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
| 2013 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 27 | Day |
Last modified on
| 2015 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012398
