UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006520 |
|---|---|
| Receipt number | R000007473 |
| Scientific Title | Effects of high dose telmisartan or combination telmisartan/amlodipine on albuminuria in patients with hypertension and type 2 diabetes |
| Date of disclosure of the study information | 2011/10/15 |
| Last modified on | 2011/10/11 18:07:40 |
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Basic information
Public title
Effects of high dose telmisartan or combination telmisartan/amlodipine on albuminuria in patients
with hypertension and type 2 diabetes
Acronym
Effects of high dose telmisartan or combInation telmisartan/amlodipine on albuminuria in patients
with hypertension and type 2 diabetes.
Scientific Title
Effects of high dose telmisartan or combination telmisartan/amlodipine on albuminuria in patients
with hypertension and type 2 diabetes
Scientific Title:Acronym
Effects of high dose telmisartan or combInation telmisartan/amlodipine on albuminuria in patients
with hypertension and type 2 diabetes.
Region
| Japan |
Condition
Condition
Microalbuminuria in patients with diabetes and hypertension
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of high dose telmisartan and telmisartan/amlodipine on blood pressure and microalbuminuria in patients with diabetes and hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the level of microalbuminuria
Key secondary outcomes
1.Blood pressure measured at home
2. Changes in the level of cholesterol profile.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Telmisartan 80mg
Interventions/Control_2
Telmisartan 40mg plus amlodipine 5mg
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.20 years of age or more
2.Diabetse with hypertension
3.Microalbuminuria
4.Under treatment with ARB
5.Patients with informed consent of this study
Key exclusion criteria
1.Patients with history of hypersensitivity to telmisartan or amlodipine
2.Patients with acute or chronic renal failure
3.Patients on dialysis
4.Patients who are pregnant, possibly lactating or pregnant
5.Patients with hyperkalemia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Daida |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-1-1, Hngo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seigo Itoh |
Organization
Juntendo University School of Medicine
Division name
Department Cardiovascular Medicine
Zip code
Address
2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Juntendo University, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School 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
| 2011 | Year | 10 | Month | 15 | 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 | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
| 2011 | Year | 10 | Month | 11 | Day |
Last modified on
| 2011 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007473
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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