UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005522 |
|---|---|
| Receipt number | R000002637 |
| Scientific Title | Hypotensive effects of telmisartan 40mg/d with diuretics compared with telmisartan 80mg/d in hypertensive patients. |
| Date of disclosure of the study information | 2011/04/28 |
| Last modified on | 2011/04/28 10:42:11 |
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Basic information
Public title
Hypotensive effects of telmisartan 40mg/d with diuretics compared with telmisartan 80mg/d in hypertensive patients.
Acronym
Hypotensive effects of telmisartan 40mg/d with diuretics compared with telmisartan 80mg/d in hypertensive patients.
Scientific Title
Hypotensive effects of telmisartan 40mg/d with diuretics compared with telmisartan 80mg/d in hypertensive patients.
Scientific Title:Acronym
Hypotensive effects of telmisartan 40mg/d with diuretics compared with telmisartan 80mg/d in hypertensive patients.
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate hypotensive effects of telmisartan 40mg/d plus hyrdochlorothiazide 12.5mg/d or plus eplerenone 50mg/d or dose increase to telmisartan and metabolic syndrome who is not insufficient effect with telmisartan 40mg/d alone.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Systolic and diastolic blood pressure
Key secondary outcomes
home blood pressure, serum 1ipids, FBG, HbA1c, IRI, hsCRP, adipocytokine, plasma renin activity, plasma aldosterone
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dose of telmisartan increased from 40mg/d to 80mg/d (6-month administration).
Interventions/Control_2
Hydrochlorothiazide 12.5mg/d add to telmisartan 40mg/d (6-month administration).
Interventions/Control_3
Eplerenone 50mg/d add to telmisartan 40mg/d (6-month administration).
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.Hypertensive patient who administrated telmisartan for three months or more, and still blood pressure is higher than Guideline target level. 2.Patient who have one or more metabolic syndorome risk factor (obesity,IGT etc.)
Key exclusion criteria
1. Pregnant or lactating women 2. Malignant hypertension and secondary hypertension 3. Diabetes mellitus patient with unstable glycemic control whose HbA1c is more than 8.0%, or complicated with diabetic nephropathy more than stage 2 4. Patient who is intoleramce or allergic aginst hydrochlorothiazide 5. FBG is more than 400mg/dL 6. patient who has kidney or liver dysfunction
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyu Takeda |
Organization
Kanazawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
13-1 takara-machi, Kanazawa, Japan
TEL
076-265-2252
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyu Takeda |
Organization
Kanazawa University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
Address
13-1 takara-machi, Kanazawa, Japan
TEL
076-265-2252
Homepage URL
takeday@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Graduate School of Medical Science, Kanazawa University
Institute
Department
Personal name
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
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
金沢大学附属病院(石川県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 28 | Day |
Last modified on
| 2011 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002637
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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