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

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 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


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

Value
https://center6.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