UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001453
Receipt number R000001759
Scientific Title Handai Candesartan anti-atherogenesis Trial on diabetic patients with hypertension using CT examination
Date of disclosure of the study information 2010/04/01
Last modified on 2012/10/23 09:12:24

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Basic information

Public title

Handai Candesartan anti-atherogenesis Trial on diabetic patients with hypertension using CT examination

Acronym

Handai Cadesartan Trial

Scientific Title

Handai Candesartan anti-atherogenesis Trial on diabetic patients with hypertension using CT examination

Scientific Title:Acronym

Handai Cadesartan Trial

Region

Japan


Condition

Condition

Type 2 diabetic patients with hypertension

Classification by specialty

Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examine the relationship between metabolic parameters and CAD using heart CT method in diabetic patients with hypertension (CAD high risk group). We also examine the effect of stronger angiotensinII receptor blockage (Candesartan 12 mg/day) on adipocytokines, metabolic parameters, and anti-atherosclerotic properties (plaque stability).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes of metabolic parameters, oxidative stress markers, adipocytokines, visceral fat areas, quality and quantity of coronary plaque, and carotid intima-media complex thickness (IMT), at the completion of treatment form baseline

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Each subject has already received orally Candesartan (4 mg or 8 mg once daily). Same dose of candesrtan will be administered for a year.

Interventions/Control_2

Each subject has already received orally Candesartan (4 mg or 8 mg once daily). When necessary, high dose of candesrtan (up to 12 mg once daily) will be administered for a year. The targets of blood pressure control are as follow; systolic <130 mmHg, diastolic <80 mmHg.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients who understand the study procedures using explanatory notes and have given written informed consent to participate in the study,
and,
2) Diabetic patients with hypertension receiving orally Candesartan (4 mg or 8 mg once daily) who be examined for the enhanced CT examination.

Key exclusion criteria

1)Contraindications of candesartan
2)Contraindications of contrast agent

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Iichiro Shimomura, Tohru Funahashi

Organization

Osaka University

Division name

Metabolic medicine

Zip code


Address

2-2 B5, Yamada-oka, Suita, Osaka, 565-0871, Japan

TEL

06-6879-3732

Email



Public contact

Name of contact person

1st name
Middle name
Last name Ken Kishida

Organization

Osaka University

Division name

Metabolic medicine

Zip code


Address

2-2 B5, Yamada-oka, Suita, Osaka, 565-0871, Japan

TEL

06-6879-3732

Homepage URL


Email

kkishida@imed2.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Metabolic Medicine, Graduate School of Medicine, Osaka University

Institute

Department

Personal name



Funding Source

Organization

Department of Metabolic Medicine, Graduate School of Medicine, Osaka University

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

2010 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/22071433

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

2008 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 04 Month 01 Day

Last follow-up date

2010 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2012 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2008 Year 10 Month 23 Day

Last modified on

2012 Year 10 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001759


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name