UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018581
Receipt No. R000020409
Scientific Title The importance of home blood pressure in patients with diabetes.
Date of disclosure of the study information 2015/08/07
Last modified on 2016/08/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The importance of home blood pressure in patients with diabetes.
Acronym home blood pressure in patients with diabetes.
Scientific Title The importance of home blood pressure in patients with diabetes.
Scientific Title:Acronym home blood pressure in patients with diabetes.
Region
Japan

Condition
Condition diabetes mellitus
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to provide an innovative thrapeutic means for the prevention and treatment of microvascular and macrovascular complications in patients with diabetes mellitus.
Basic objectives2 Others
Basic objectives -Others The aim of the present study is to compare the effects on home blood pressure and home blood pressure variability of combination therapy of olmesartan combined with azelnidipine or trichlormethiazide in patients with type 2 diabetes mellitus using home blood pressure telemonitoring system.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes home blood pressure and home blood pressure variability at least 28 days after randomization or switching drugs.
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 olmesartan 20mg and azelnidipine 16mg, olmesartan 20mg and trichlormethiazide 1mg for more than 6 weeks each
We used HBP data at least 28 days after randomization or switching drugs.
Interventions/Control_2 olmesartan 20mg and trichlormethiazide 1mg, olmesartan 20mg and azelnidipine 16mg for more than 6 weeks each
We used HBP data at least 28 days after randomization or switching drugs.
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
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Inclusion criteria were as follows: 40-80 years, type 2 diabetes mellitus, hypertension with the use of RAS inhibitors, RAS inhibitors and CCBs, or RAS inhibitors and diuretics.
Key exclusion criteria Exclusion criteria were as follows: secondary hypertension or malignant hypertension, history of cerebrovascular accident, myocardial infarction or hospitalization for angina pectoris within 6 months before evaluation for study entry, advanced liver or renal dysfunction (serum creatinine equal to or more than 2.0mg/dl or current treatment by dialysis), atrial fibrillation or severe arrhythmia, prescribed 3 and over antihypertensive drugs, prescribed other class of antihypertensive drugs than study drugs (that is, RAS inhibitors, CCBs or diuretics), history of side effects from study drugs, life-threatening condition like malignant tumor or not suited to be a study patients as judged by a physician in charge.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Fukui
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Endocrinology and Metabolism
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5505
Email michiaki@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Emi Ushigome
Organization Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name Department of Endocrinology and Metabolism
Zip code
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5505
Homepage URL
Email emis@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department

Funding Source
Organization Emi Ushigome received grant support from Japanese Study Group for Physiology and Management of Blood Pressure and Astellas Foundation for Research on Metabolic Disorders.
Organization
Division
Category of Funding Organization Other
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
2015 Year 08 Month 07 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 Completed
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 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
2015 Year 08 Month 07 Day
Last modified on
2016 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020409

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.