UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006081 |
|---|---|
| Receipt number | R000007197 |
| Scientific Title | Comparison of azelnidipine and trichlormethiazide in Japanese type 2 diabetic patients with hypertension: the COAT randomized controlled trial |
| Date of disclosure of the study information | 2011/07/30 |
| Last modified on | 2013/07/24 10:54:28 |
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Basic information
Public title
Comparison of azelnidipine and trichlormethiazide in Japanese type 2 diabetic patients with hypertension: the COAT randomized controlled trial
Acronym
the COAT randomized controlled trial
Scientific Title
Comparison of azelnidipine and trichlormethiazide in Japanese type 2 diabetic patients with hypertension: the COAT randomized controlled trial
Scientific Title:Acronym
the COAT randomized controlled trial
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
This study compared the efficacy and safety of azelnidipine with that of trichlormethiazide in Japanese type 2 diabetic patients with hypertension who were being treated with olmesartan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Main outcome measure was the difference in the change in HbA1c levels from the baseline values at 48 weeks between these two groups.
Key secondary outcomes
Key secondary outcomes were the levels of sBP, dBP, fasting plasma glucose (FPG), fasting insulin (FI), inflammation mediators, adiponectin, and markers of lipids, uric acid, liver function and renal function.
Frequency of side effects such as vertigo, dizziness, and edema after administration of azelnidipine or trichlormethiazide.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with azelnidipine (16mg/day). Collection of blood and urine at 0, 24 and 48 weeks after administration of the agent.
Interventions/Control_2
Treatment with trichlormethiazide (1mg/day). Collection of blood and urine at 0, 24 and 48 weeks after administration of the agent.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with adequately controlled diabetes (HbA1c < 7.0%) and inadequately controlled hypertension (systolic blood pressure [sBP] < 130 mmHg or diastolic blood pressure [dBP] < 80 mmHg) who were being treated with olmesartan.
Key exclusion criteria
1. Patients with history of diabetic ketoacidosis, or diabetic coma within 6 months prior to the study entry.
2. Patients who received other antidiabetic within 3 months prior to the study entry.
3. Patients who received surgical operation during the study.
4. Patients with severe infection or severe trauma.
5. Patients with during pregnancy or lactation.
6. Patients with severe liver dysfunction.
7. Patients with severe renal dysfunction.
8. Patients who received insulin therapy.
9. Patients who received steroid therapy.
10. Patients with history of hypersensitivity reaction to azelnidipine or trichlormethiazide.
11. Patients determined to be inappropriate by physician.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terauchi |
Organization
Yokohama City Unuversity School of Medicine
Division name
Department of Endcrinology & Metabolism
Zip code
Address
3-9 Fukuura, Kanazawa-Ku, Yokohama City 236-0004
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Takihata |
Organization
Yokohama City Unuversity School of Medicine
Division name
Department of Endcrinology & Metabolism
Zip code
Address
3-9 Fukuura, Kanazawa-Ku, Yokohama City 236-0004
TEL
0457872800
Homepage URL
Sponsor or person
Institute
Yokohama City Unuversity School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City Unuversity 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
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 | 07 | Month | 30 | 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
| 2011 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 30 | Day |
Last modified on
| 2013 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007197
