UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001802
Receipt No. R000002176
Scientific Title Investigation of effective treatment of nocturnal hypertension in diabetes
Date of disclosure of the study information 2009/07/01
Last modified on 2017/04/02

* 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 Investigation of effective treatment of nocturnal hypertension in diabetes
Acronym Treatment of nocternal hypertension in diabetes with new blood pressure measureing method
Scientific Title Investigation of effective treatment of nocturnal hypertension in diabetes
Scientific Title:Acronym Treatment of nocternal hypertension in diabetes with new blood pressure measureing method
Region
Japan

Condition
Condition Nocturnal hypertension in type 2 DM
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effects on noucurnal hypertension with changing ARB and CCB to losartan/ hydrochlorothiazide in type 2 diabetes
Basic objectives2 Others
Basic objectives -Others effects on metabolic parameter
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Change in nocturnal blood pressure level after 12 weeks of treatment
Key secondary outcomes change in blood pressure level on an outpatient basis after 4,8 weeks of treatment
change after12 weeks about
HbA1c, fasting bllod glucose level, urine alubimin excretion, Urine Na, Crine K, renin, aldsterone, BNP, serum K, serum Na, serum UA, serum Creatinine, eGFR, LDL-C, TG, HDL-C

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Losartan / hydrochlorothiazide group
Interventions/Control_2 ARB and CCB group
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) Hypertensive diabetic patients, who have been treated with ARB and Carcium channnel blocker for more than 4weeks, but not reached systolic blood pressure to 150 mmHg and /or diastolic blood pressure to 100 mmHg
2) aged more than 20 years
3) men and women
4) patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to patients in the study
Key exclusion criteria 1) patients with secondary hypertension
2) patients with liver dysfunction (GPT over three times the normal value)
3) patients with renal failure (serum creatinine over 2.0 mg/dL)
4) patients with bilareral renal artery stenosis
5) pregnant or possible pregnant women
6) patients with a history of hypersensitivity to Losartan or thiazide
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kazuhiko sakaguchi
Organization Kobe University Graduate School of Medicine
Division name Division of deabetes, metabolism and endocrinology
Zip code
Address 7-5-1, Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017 Japan
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 Kobe University Graduate School of Medicine
Division name Division of deabetes, metabolism and endocrinology
Zip code
Address 7-5-1, Kusunoki-Cho, Chuo-Ku, Kobe, 650-0017 Japan
TEL 078-382-5861
Homepage URL
Email kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Division of deabetes, metabolism and endocrinology
Institute
Department

Funding Source
Organization Division of deabetes, metabolism and endocrinology
Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
2009 Year 07 Month 01 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 05 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2011 Year 03 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
2009 Year 03 Month 26 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=R000002176

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.