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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000383
Receipt No. R000000476
Scientific Title Metabolic effect of telmisartan and losartan in peritoneal dialysis patients
Date of disclosure of the study information 2006/03/31
Last modified on 2009/04/01

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Basic information
Public title Metabolic effect of telmisartan and losartan in peritoneal dialysis patients
Acronym Metabolic effect of telmisartan and losartan in peritoneal dialysis patients
Scientific Title Metabolic effect of telmisartan and losartan in peritoneal dialysis patients
Scientific Title:Acronym Metabolic effect of telmisartan and losartan in peritoneal dialysis patients
Region
Japan

Condition
Condition peritoneal dialysis patients
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Telmisartan,an antihypertensive agent with evidence of partial peroxisome activity-gamma activity may improve insulin sensitivity and lipid profile in PD patients.The aim of the present study is to compare the glucometabolic effect of telmisartan and losartan in PD patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes effect on lipid profile and insulin sensitivity;waist,BMI,T-Cho,TG,LDL-C,leptin,HOMA-IR,values of glucose and insulin in the oral glucose tolerance test
Key secondary outcomes 1)effect on inflammation;serum hsCRP,IL-
6,TNFarfa
2)effect on blood pressure;ambulatory
blood pressure monitoring
3)effect on residual renal function;
renal Ccr,urine protein

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 losartan(25mg or 50mg twice a day) for 3 months,then telmisartan(20mg or 40 mg twice a day)for 3 months,then losartan(25mg or 50mg twice a day) for 3 months
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria non-diabetic peritoneal dialysis patients
Key exclusion criteria 1)morning blood pressure < 125/75mmHg in a sitting position without any antihypertensive
2)patients with hyperkalemia(K>6.0 mEq/l)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Harumi Kitamura
Organization Department of Internal Medicine,Osaka University School of Medicine
Division name Devision of Nephrology
Zip code
Address 2-2,yamadaoka,suita-city,Osaka,Japan
TEL 06-6879-3632
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Department of Internal Medicine,Osaka University School of Medicine
Division name Devision of Nephrology
Zip code
Address
TEL 06-6879-3632
Homepage URL
Email

Sponsor
Institute Department of Internal Medicine,Osaka University School of Medicine
Devision of Nephrology
Institute
Department

Funding Source
Organization Boehringer ingelheim
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2006 Year 03 Month 31 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 Completed
Date of protocol fixation
2006 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2006 Year 03 Month 01 Day
Last follow-up date
2007 Year 01 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 30 Day
Last modified on
2009 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000476

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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