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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020632
Receipt No. R000023801
Scientific Title Effects of high dose angiotensin II receptor blocker or combination of angiotensin II and calcium channel blocker on ambultory blood pressure in patients with hypertension and type 2 diabetes (randomized controlled clinical trial)
Date of disclosure of the study information 2016/01/20
Last modified on 2016/01/19

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Basic information
Public title Effects of high dose angiotensin II receptor blocker or combination of angiotensin II and calcium channel blocker on ambultory blood pressure in patients with hypertension and type 2 diabetes (randomized controlled clinical trial)
Acronym Effects of high dose angiotensin II receptor blocker or combination of angiotensin II and calcium channel blocker on ambultory blood pressure in patients with hypertension and type 2 diabetes
Scientific Title Effects of high dose angiotensin II receptor blocker or combination of angiotensin II and calcium channel blocker on ambultory blood pressure in patients with hypertension and type 2 diabetes (randomized controlled clinical trial)
Scientific Title:Acronym Effects of high dose angiotensin II receptor blocker or combination of angiotensin II and calcium channel blocker on ambultory blood pressure in patients with hypertension and type 2 diabetes
Region
Japan

Condition
Condition Hypertension with type 2 diabetes mellitus
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of high dose angiotensin II receptor blocker or combination of angiotensin II and calcium channel blocker in patients with hypertension and type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change in ambulatory blood pressure (nighttime SBP) between baseline and after 12 weeks of treatment
Key secondary outcomes

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 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Olmesartan medoxomil 40 mg daily
Interventions/Control_2 Olmesartan medoxomil 20 mg plus azelnidipine 16 mg daily
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) hypertension
(2) age >= 20
(3) type 2 diabetes
Key exclusion criteria (1) secondary hypertension
(2) past histody of cardiovascular disease
(3) resistant hypertension
(4) inadequacy for this therapy
(5) severe renal dysfunction (eGFR < 45 mL/min/1.73m2)
(6) severe liver dysfunction (Child-Pugh: class B or C)
(7) having malignancy or collagen disease
(8) chronic Af
(9) pregnancy or lactation in women
(10) history of allergy for olmesartan medoxomil or azelnidipine
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Furusyo
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5909
Email furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motohiro Shimizu
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5909
Homepage URL
Email smotohir@gim.med.kyushu-u.ac.jp

Sponsor
Institute Department of General Internal Medicine, Kyushu University Hospital
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
2016 Year 01 Month 20 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 Open public recruiting
Date of protocol fixation
2013 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 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
2016 Year 01 Month 19 Day
Last modified on
2016 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023801

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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