UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009825 |
|---|---|
| Receipt number | R000009098 |
| Scientific Title | Effect of the long acting ARB in hypertensive patients with cerebro vasucular disease not controlled by conventional therapy. |
| Date of disclosure of the study information | 2013/01/21 |
| Last modified on | 2013/01/21 11:57:54 |
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Basic information
Public title
Effect of the long acting ARB in hypertensive patients with cerebro vasucular disease not controlled by conventional therapy.
Acronym
Effect of the long acting ARB in hypertensive patients with cerebro vasucular disease not controlled by conventional therapy.
Scientific Title
Effect of the long acting ARB in hypertensive patients with cerebro vasucular disease not controlled by conventional therapy.
Scientific Title:Acronym
Effect of the long acting ARB in hypertensive patients with cerebro vasucular disease not controlled by conventional therapy.
Region
| Japan |
Condition
Condition
Cerebrovasucular Disease,
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of telmisartan on central blood pressure in hypertensive patients with cerebro vasucular disease not controlled by conventional therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Central blood pressure
Key secondary outcomes
Clinic BP
24hr BP on ABPM
IMT(Intra Media Dilation)
FMD(Flow Mediated Dilation)
Control rate of Clinic BP
Control rate of ABPM
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Telmisartan 80mg/day
Interventions/Control_2
Maximum dose ARB which was Prescribed originally
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients to fulfill all the following condition can participate
1)Hypertension with cerebrovasucular disease
2)Under treatment with ARB is not telmisartan more than 3 months
3)Clinic BP:SBP>=140 and/or DBP>=90
4)40 years of age and more
5)Patients with informed consent of this study
Key exclusion criteria
1)Secondary hypertension
2)Severe hypertension with SBP>=180mmHg and/or DBP>=110mmHg
3)Malignant hypertension
4)Severe heart failure (NYHA III-IV)
5)Myocardial Infarction, Coronary bypass surgery, and PTCA were performed within 6 months
6)Patients contraindicated for the use of ARBs
7)Serum creatinine >=2.1mg/dL
8)Untreated hyperuricemia or serum uric acid>8mg/dL
9)Diabetes patients under insulin treatment, or HbA1c>9.0%
10)Patients with hypoglycemia
11)Patients who are inadequate by determination of physicians in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Uchiyama |
Organization
Tokyo Women's Medical University
Division name
Department of Neurology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Women's Medical University
Division name
Department of Neurology
Zip code
Address
TEL
03-3353-8111
Homepage URL
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical 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
| 2013 | Year | 01 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 21 | Day |
Last modified on
| 2013 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009098
