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


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 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


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

Value
https://center6.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