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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009186
Receipt No. R000010754
Scientific Title Anti-inflammatory effect of telmisartan in patients with hypertension
Date of disclosure of the study information 2012/11/01
Last modified on 2015/11/17

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Basic information
Public title Anti-inflammatory effect of telmisartan in patients with hypertension
Acronym Anti-inflammatory effect of telmisartan in patients with hypertension
Scientific Title Anti-inflammatory effect of telmisartan in patients with hypertension
Scientific Title:Acronym Anti-inflammatory effect of telmisartan in patients with hypertension
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Nephrology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy and anti-inflammatory effect of telmisartan in Hypertension patients who did not get any hypertensive treatment or reach target blood pressure by other agents except renin angiotensin system blocker
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The levels of blood pressure, blood/urinary sTNFRs, TNFalpha, OPG, Osteopontin, hs-CRP, IL-6 and MCP-1
Key secondary outcomes The levels of BW, BMI, e-GFR, albuminuria, serum lipid(TC/TG/HDL-C), and HbA1c

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 telmisartan
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Uncontorable hypertension(SBP>130mmHg or DBP>110mmHg)
(2)Patients whose serum creatinine does not rise rapidly
(3)Patients who do not take the renin-angiotensin system inhibitor
(4)Ambulant patient
(5)Patients of 20 years and upward
Key exclusion criteria (1)Allergy against telmisartan
(2)Secondary hyperuricemia
(3)Systolic BP > 180mmHg, or diastolic BP > 110mmHg
(4)Patients with ALT or AST more than twice
(5)History of cardiovascular disease and stroke in the previous 6 months.
(6)Pregnant women
(7)Patients who are not recommended for participation in this study by physician in charge with medical reasons
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tomohito Gohda
Organization Juntendo University Faculty of Medicine
Division name Division of Nephrology, Department of Internal Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Juntendo University Faculty of Medicine
Division name Division of Nephrology, Department of Internal Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5802-1065
Homepage URL
Email

Sponsor
Institute Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine
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
2012 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2012 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 11 Month 16 Day

Other
Other related information

Management information
Registered date
2012 Year 10 Month 25 Day
Last modified on
2015 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010754

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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