UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000666 |
|---|---|
| Receipt number | R000000801 |
| Scientific Title | Effects of ARBs on ambulatory blood pressure, glucose and lipid metabolism, and autonomic nerve function in hypertensive diabetic nephropathy patients |
| Date of disclosure of the study information | 2008/11/01 |
| Last modified on | 2015/09/19 09:54:30 |
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Basic information
Public title
Effects of ARBs on ambulatory blood pressure, glucose and lipid metabolism, and autonomic nerve function in hypertensive diabetic nephropathy patients
Acronym
Effects of ARBs on ambulatory blood pressure, glucose and lipid metabolism, and autonomic nerve function in hypertensive diabetic nephropathy patients
Scientific Title
Effects of ARBs on ambulatory blood pressure, glucose and lipid metabolism, and autonomic nerve function in hypertensive diabetic nephropathy patients
Scientific Title:Acronym
Effects of ARBs on ambulatory blood pressure, glucose and lipid metabolism, and autonomic nerve function in hypertensive diabetic nephropathy patients
Region
| Japan |
Condition
Condition
Hypertension, type 2 diabetes, diabetic nephropathy
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will compare telmisartan with losartan in blood pressure profile including short-term blood pressure variability and in metabolic profile in thirty patients with overt diabetic nephropathy by cross-over design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
1) Ambulatory blood pressure monitoring+: mean blood pressure, day-night variation, short-term blood pressure/heart rate variability, LF/HF
2) Renal function: creatinine clearance by Cockcroft-Gault method, urinary protein/albuminon excretion
3) Glucose metabolism: fasting blood glucose, fasting IRI, HOMA-IR.
4) Lipid metabolism: total cholesterol, LDL, HDL, MDA-LDA, oxidised cholesterol, small dense LDL, adiponectin.
5) Vascular function: ABI/baPWV, VEGF, HGF.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TL group: Start with once-daily dosing of telmisartan 40 mg, and dosage may be modulated accroding to the clinical parameters (telmisartan 20-80 mg/day). After 12 weeks telmisartan will be changed to losartan with once-daily dosing of 50 mg. Dosage may be modulated accroding to the clinical parameters (losartan 25-100 mg/day).
Interventions/Control_2
LT group: Start with once-daily dosing of losartan 50 mg, and dosage may be modulated accroding to the clinical parameters (losartan 25-100 mg/day).. After 12 weeks losartan will be changed to telmisartan with once-daily dosing of 40 mg. Dosage may be modulated accroding to the clinical parameters (telmisartan 20-80 mg/day).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes
Mild-to-moderate hypertension (more than casual BP 130/85 or on antihypertensives)
Urinary protein excretion more than 0.3 g/day
Serum creatinine below 3.0 mg/dl
Age above 18 years
Key exclusion criteria
1) Pregnant women, or women suspected of being pregnant
2) Hyperkalemia
3) History of hypersensitivity to Telmisartan or Losartan
4) Severe liver disorder (losartan)
5) Severe biliary atresia or hepatic disorder (telmisartan)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouichi TAMURA |
Organization
Yokohama City University School of Medicine
Division name
Department of Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2635
tamukou@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuaki UCHINO |
Organization
Yokohama City University School of Medicine
Division name
Department of Medical Science
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2634
Homepage URL
uchinok@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Cardiorenal Medicine, Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiorenal Medicine, Yokohama City University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2008 | Year | 11 | Month | 01 | 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
| 2004 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 04 | Month | 02 | Day |
Last modified on
| 2015 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000801
