UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012767 |
|---|---|
| Receipt number | R000014911 |
| Scientific Title | MULTICENTER PROBE STUDY-3; COMPARISON OF THE EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS |
| Date of disclosure of the study information | 2014/01/06 |
| Last modified on | 2017/07/25 22:24:19 |
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Basic information
Public title
MULTICENTER PROBE STUDY-3; COMPARISON OF THE EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS
Acronym
MUSCAT-3
Scientific Title
MULTICENTER PROBE STUDY-3; COMPARISON OF THE EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS
Scientific Title:Acronym
MUSCAT-3
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of irbesartan with the other ARBs on 1) inflammatory markers and oxidative stress markers 2) renal function and albminuria in the out-patients with hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in MCP-1, MDA-LDL, Pentraxin-3, hs-CRP
Key secondary outcomes
Change in the clinic and home blood pressure, renal function(serum creatinine, uric acid, pottasium, eGFR), Lipids(LDL-C, HDL-C, T.cho), U-Alb/Cr
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To switch the previous ARB(Losartan, Candesartan, Valsartan, Telmisartan, Olmesartan) to Irbesartan, then treat the patients for 24 weeks.
Interventions/Control_2
To continue the previous ARBs (Losartan, Candesartan, Valsartan, Telmisartan, Olmesartan) for 24 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The uncontrolled out-patients with hypertension who have treated with the other ARBs (Losartan, Candesartan, Valsartan, Telmisartan, Olmesartan) for more than 3 months.
Key exclusion criteria
The patients with
1) severe renal dysfunction (Cr > 2.0 mg/dl)
2) severe hepatic dysfunction (AST or ALT > 100IU/l)
3) the history of severe side effect of ARBs
4) pregnancy or lactation
5) malignancy or other poor-prognosis disease
6) those who are considered inappropriate by physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhito Adam Uchida |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Medicine and Clinical Sciences,
Zip code
Address
2-5-1 Shikata-cho Kita-ku Okayama city, 700-8558, Japan
TEL
086-235-7235
hauchida@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhito Adam Uchida |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Medicine and Clinical Sciences,
Zip code
Address
2-5-1 Shikata-cho Kita-ku Okayama city, 700-8558, Japan
TEL
086-235-7235
Homepage URL
sannai@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Medicine and Clinical Sciences,
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 06 | Day |
Last modified on
| 2017 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014911
