UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000797 |
|---|---|
| Receipt number | R000000954 |
| Scientific Title | Effect of Termisartan or Losartan in Hypertensive Diabetic Patients with Macroalbumiuria |
| Date of disclosure of the study information | 2007/08/10 |
| Last modified on | 2016/04/27 21:24:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Termisartan or Losartan in Hypertensive Diabetic Patients with Macroalbumiuria
Acronym
MOLOYAMA Study
Scientific Title
Effect of Termisartan or Losartan in Hypertensive Diabetic Patients with Macroalbumiuria
Scientific Title:Acronym
MOLOYAMA Study
Region
| Japan |
Condition
Condition
Hypertensive Diabetic Nephropathy Patients with Macroalbumiuria
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of telmisartan and losartan in hypertensive diabetic patients with macroalbumiuria
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Changes of urinary excretion of protein after 12 weeks of treatment
Key secondary outcomes
1) Changes in office blood pressure after 12 weeks treatment
2) Changes in serum creatinine,high molecular adeponectine, potassium, total cholestero, HDL-cholesterol, triglyceride, blood glucose, IRI, HbA1c, HOMA-IR after 12 weeks of treatment
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continue oral administration of Losartan (25-100mg/day)
Interventions/Control_2
Switch to oral administration of Telmisartan (20-80mg/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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diabetic nephropathy patients with macroalbumiuria (Urinary Protein >1+)
2)Hypertensive patients taking Losartan
Key exclusion criteria
1) Non diabetic nephropathy (e.g. IgA nephropathy, Nephrosclerosis, etc)
2) Patients who are taking ACRs and/or ARBs other than Losartan
3) Serum creatinine > 3.0mg/dl
4) Severe hypertension (Diastolic blood pressure > 120mmHg)
5) Patients who are inadequate to entry this study by physicians in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetomo Nakamoto |
Organization
Saitama Medical University
Division name
Department of General Medicine
Zip code
Address
38Morohongo, Moriyamamachi, Iruma-gun, Saitama 350-0451, Japan
TEL
049-276-1611
nakamo_h@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetomo Nakamoto |
Organization
Saitama Medical University
Division name
Department of General Medicine
Zip code
Address
38Morohongo, Moroyamamachi, Iruma-gun, Saitama 350-0451, Japan
TEL
049-276-1611
Homepage URL
nakamo_h@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2007 | Year | 08 | Month | 10 | 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
| 2007 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 08 | Month | 09 | Day |
Last modified on
| 2016 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000954
