UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018581 |
|---|---|
| Receipt number | 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 10:00:01 |
* 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
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
emis@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.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 |
