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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006081
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Yokohama City Unuversity School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007197

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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