UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009186 |
|---|---|
| Receipt number | 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 11:35:25 |
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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
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
Public contact
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
Sponsor or person
Institute
Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010754
