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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010604
Receipt No. 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

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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
Email 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
Email toiwasaki-dm@umin.ac.jp

Sponsor
Institute Iwasaki Naika Clinic
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012398

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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