UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000299 |
|---|---|
| Receipt number | R000000383 |
| Scientific Title | Randomized trial of telmisartan and/or enalapril on renoprotective effects for patients of chronic renal diseases with hypertension. |
| Date of disclosure of the study information | 2005/12/21 |
| Last modified on | 2015/07/14 13:10:20 |
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Basic information
Public title
Randomized trial of telmisartan and/or enalapril on renoprotective effects for patients of chronic renal diseases with hypertension.
Acronym
Telmisartan, Enalapril vs Combination for Hypertension and Nephropathies: Intervensive Controlled trial.
Scientific Title
Randomized trial of telmisartan and/or enalapril on renoprotective effects for patients of chronic renal diseases with hypertension.
Scientific Title:Acronym
Telmisartan, Enalapril vs Combination for Hypertension and Nephropathies: Intervensive Controlled trial.
Region
| Japan |
Condition
Condition
Chronic Kidney Diseases
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the renoprotective effects of treatments with angiotensin converting enzyme-inhibitor &/or angiotensin receptor blocker.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Effects of treatments with angiotensin converting enzyme-inhibitor &/or angiotensin receptor blocker on blood pressure, excretion of urinary protein, serum creatinine level and creatinine clearance.
Key secondary outcomes
Adverse effects of angiotensin converting enzyme-inhibitor &/or angiotensin receptor blocker.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Termisartan 20-80 mg daily, over 1 year
Interventions/Control_2
Enalapril 2.5 to 10 mg daily, over 1 year
Interventions/Control_3
Termisartan 20 to 80 mg and enalapril 2.5 to 10 mg daily, over 1 year
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
| Not applicable |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with hypertension (blood pressure over 130/80 mmHg) and proteinuria (over plus-minus by dipstick).
Key exclusion criteria
Patients with allergy for angiotensin converting enzyme-inhibitor or angiotensin receptor blocker, liver injury, or pregnancy. Patients who are inadequate to entry this study by physicians in charge.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Koyama |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
President
Zip code
Address
4669-2 Ohaza Ami, Ami, Inashiki, Ibaraki
TEL
029-888-4000
kidney@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keigyou Yoh |
Organization
Institute of Clinical Medicine, University of Tsukuba
Division name
Division of Nephrology
Zip code
Address
1-1-1 Ten-nodai, Tsukuba, Ibaraki
TEL
029-853-3202
Homepage URL
kidney@md.tsukuba.ac.jp
Sponsor or person
Institute
Institute of Clinical Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Department account fund
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Ibaraki Prefectural University of Health Sciences
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
| 2005 | Year | 12 | 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
Because there was little accumulation of the number of cases, this study was terminated.
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
Terminated
Date of protocol fixation
| 2005 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 12 | Month | 21 | Day |
Last modified on
| 2015 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000383
