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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001453
Receipt No. 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

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

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
URL(English) https://upload.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


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