UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000383 |
|---|---|
| Receipt number | 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 10:12:01 |
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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
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
Sponsor or person
Institute
Department of Internal Medicine,Osaka University School of Medicine
Devision of Nephrology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000476
