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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002205
Receipt No. R000002712
Scientific Title Investigation about treatment of midnight hypertension in diabetes
Date of disclosure of the study information 2009/09/15
Last modified on 2017/04/02

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Basic information
Public title Investigation about treatment of midnight hypertension in diabetes
Acronym Investigation about treatment of midnight hypertension in diabetes
Scientific Title Investigation about treatment of midnight hypertension in diabetes
Scientific Title:Acronym Investigation about treatment of midnight hypertension in diabetes
Region
Japan

Condition
Condition hypertension in diabetes
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the best combination of Ca antagonist and ARB in the treatment of hypertensive diabetes patients using ambulatory blood pressure monitoring
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes comparison of the anti-hypertensive effect through the 24 hrs
Key secondary outcomes change in urinary albumin excretion ratio

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 olmesartan 20 mg +amlodipine 5mg
once daily
Interventions/Control_2 olmesartan 20 mg + azelnidipine 16 mg
once daily
Interventions/Control_3 candesartan 8 mg or varsartan 80 mg + amlodipine 5mg
once daily
Interventions/Control_4 candesartan 8 mg or varsartan 80 mg + azelnidipine 16 mg
once daily
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
79 years-old >
Gender Male and Female
Key inclusion criteria diabetes patient having midnight hypertension
Key exclusion criteria 1) drug allergy to ARB or Ca antagonist
2) pregnant women or possible pregnant women
3) using anti-fugal drug or HIV protease inhibitor
4) bilateral renal artery stenosis or unilateral renal artery stenosis of remnant kidny
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko sakaguchi
Organization Department od Internal Medicine, Kobe University Graduate School of Medicine
Division name Division of diabetes, metabolism and Endocrinology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5861
Email kzhkskgc@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko sakaguchi
Organization Department od Internal Medicine, Kobe University Graduate School of Medicine
Division name Division of diabetes, metabolism and Endocrinology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-5861
Homepage URL
Email kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute Division of diabetes, metabolism and Endocrinology
Department od Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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
2009 Year 09 Month 15 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 Terminated
Date of protocol fixation
2009 Year 06 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2013 Year 07 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 15 Day
Last modified on
2017 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002712

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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