UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003459 |
|---|---|
| Receipt number | R000004187 |
| Scientific Title | Combination therapy with azelnidipine or trichlormethiazide added on olmesartan in hypertensive patients with glucose intolerance |
| Date of disclosure of the study information | 2010/04/07 |
| Last modified on | 2014/08/14 16:52:06 |
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Basic information
Public title
Combination therapy with azelnidipine or trichlormethiazide added on olmesartan in hypertensive patients with glucose intolerance
Acronym
Combination therapy with azelnidipine or trichlormethiazide added on olmesartan in hypertensive patients with glucose intolerance
Scientific Title
Combination therapy with azelnidipine or trichlormethiazide added on olmesartan in hypertensive patients with glucose intolerance
Scientific Title:Acronym
Combination therapy with azelnidipine or trichlormethiazide added on olmesartan in hypertensive patients with glucose intolerance
Region
| Japan |
Condition
Condition
Hypertension with glucose intolerance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of usefulness of azelnidipine when using it together with RAS inhibitor olmesartan as compared to trichlormethiazide+olmesartan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Insulin sensitivity
Key secondary outcomes
Changes in blood pressure level at home after gettin up.
Aggravation of the renal function.
changes in urinary albumin level,albuminuria,eGFR.
hsCRP,8-OHDG,uric acid,K,
new onset of diabetes.
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(5-40mg)+azelnidipine(8-16mg)day
Interventions/Control_2
olmesartan(5-40mg)+trichlormethiazide(0.5-1.0mg)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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hypertensive outpatients with glucose intolerance
1)Among patients on Olmesartan
blood pressure 130/80mmHg moreover
blood pressure at home 125/75mmHg moreover
2)FBS 100mg/dl moreover
HbA1c 5.2 moreover
Key exclusion criteria
1)Among patients on azelnidipine or trichlormethiazide
2)Severe hepatic disease
3)Severe renal disease(During dialysis)
4)pregnancy or possibility of the pregnancy
5)posses hypersensitivity to azelnidipine or trichlormethiazide
6)Patients with insulin treatment or scheduling the insulin administration
7)FBS 100mg/dl moreover
HbA1c 5.2 moreover
8)Patients who are inadequate to entry this study by physians in charge
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Koya |
Organization
Kanazawa Medical University
Division name
Diabetes & Endocrinology
Zip code
Address
Daigaku1-1 Uchinadamachi Kahokugun Ishikawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Koya |
Organization
Kanazawa Medical University
Division name
Diabetes & Endocrinology
Zip code
Address
Daigaku1-1 Uchinadamachi Kahokugun Ishikawa
TEL
Homepage URL
Sponsor or person
Institute
Kanazawa Medical University Diabetes & Endocrinology
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University Diabetes & Endocrinology
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
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
| 2010 | Year | 04 | 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
| 2009 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | 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
| 2010 | Year | 04 | Month | 07 | Day |
Last modified on
| 2014 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004187
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
