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
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
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
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
