UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000469 |
|---|---|
| Receipt number | R000000570 |
| Scientific Title | Study on pleiotropic effects of angiotensin II- receptor blockers (ARB) in hypertensive obese patients. |
| Date of disclosure of the study information | 2006/09/01 |
| Last modified on | 2011/09/06 08:58:21 |
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Basic information
Public title
Study on pleiotropic effects of angiotensin II- receptor blockers (ARB) in hypertensive obese patients.
Acronym
Effects of ARBs in hypertensive obese patients.
Scientific Title
Study on pleiotropic effects of angiotensin II- receptor blockers (ARB) in hypertensive obese patients.
Scientific Title:Acronym
Effects of ARBs in hypertensive obese patients.
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validate the usefulness of ARB in obese patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in fasting plasma glucose and insulin levels
Change in serum lipid profile
Change in high-sensitive CRP
Key secondary outcomes
Change in serum adiponectin level
Change in serum AGE-2
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Normal dosage of telmisartan is administered for 6 months after randomization
Interventions/Control_2
Normal dosage of valsartan is administered for 6 months after randomization
Interventions/Control_3
Normal dosage of candesartan is administered for 6 months after randomization
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with obesity whose BMI exceeding 25
2. Patients with hypertension (Systolic blood pressure is >=140 or diastolic >=90)
Key exclusion criteria
-patients with secondary hypertension
-patients whose AST or ALT exceeding 100IU/L
-patients with bile stenosis
-patients with severe renal failure or nephrotic syndrome
-patients with severe cerebral infarction
-pregnant women or those who plan pregnancy, or in the lactation period
-patients with neoplasm
-patients with history of hypersensitivity to telmisartan, valsartan, or candesartan
-other patients judged unsuitable for the study by the investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamitsu Nakazato |
Organization
Department of Internal Medicine, University of Miyazaki Faculty of Medicine
Division name
Neurology, Respirology, Endocrinology and Metabolism
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692
TEL
0985-85-2965
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanari Mizuta |
Organization
Department of Internal Medicine, University of Miyazaki Faculty of Medicine
Division name
Neurology, Respirology, Endocrinology and Metabolism
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692
TEL
0985-85-2965
Homepage URL
mmizuta@fc.miyazaki-u.ac.jp
Sponsor or person
Institute
3M STUDY GROUP
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2006 | Year | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2004 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 08 | Month | 15 | Day |
Last modified on
| 2011 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000570
