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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000299
Receipt No. 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

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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
Email 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
Email kidney@md.tsukuba.ac.jp

Sponsor
Institute Institute of Clinical Medicine, University of Tsukuba
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000383

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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