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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000469
Receipt No. 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

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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
Email

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
Email mmizuta@fc.miyazaki-u.ac.jp

Sponsor
Institute 3M STUDY GROUP
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000570

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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