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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005064
Receipt No. R000006023
Scientific Title Comparison of effects of azelnidipine and trichlormethiazide in combination with olmesartan on blood pressure and metabolic parameters in hypertensive type 2 diabetic patients
Date of disclosure of the study information 2011/02/11
Last modified on 2011/02/10

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Basic information
Public title Comparison of effects of azelnidipine and trichlormethiazide in combination with olmesartan on blood pressure and metabolic parameters in hypertensive type 2 diabetic patients
Acronym Comparison of CCB and thiazide diuretics
Scientific Title Comparison of effects of azelnidipine and trichlormethiazide in combination with olmesartan on blood pressure and metabolic parameters in hypertensive type 2 diabetic patients
Scientific Title:Acronym Comparison of CCB and thiazide diuretics
Region
Japan

Condition
Condition type 2 diabetic patients with hypertension
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the effects of combination treatment of ARB (olmesartan, 20 mg/day) with a calcium channel blocker (CCB) or with a low-dose thiazide diuretic on blood pressure (BP) and various metabolic parameters in hypertensive patients with type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of the effects on blood pressure (BP) and various metabolic parameters.
Key secondary outcomes

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 azelnidipine (16 mg/day)
Interventions/Control_2 trichlormethiazide (1 mg/day)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The inclusion criteria were patients with type 2 diabetes mellitus and hypertension in whom the target clinic blood pressure (<130/80 mmHg) could not be achieved despite treatment with olmesartan 20 mg once daily
Key exclusion criteria Patients with HbA1c higher than 8.4% were excluded from the study. In addition, patients with severe renal or hepatic disease, overt cardiovascular disease, and malignancy were excluded
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoya Mita
Organization Juntendo University Graduate School of Medicine
Division name Department of Medicine, Metabolism and Endocrinology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University Graduate School of Medicine
Division name Metabolism and Endocrinology
Zip code
Address
TEL 03-3813-3111
Homepage URL
Email

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization Juntendo University Graduate School of Medicine
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
2011 Year 02 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially 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
2007 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 02 Month 10 Day
Last modified on
2011 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006023

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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