UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012768 |
|---|---|
| Receipt number | R000014912 |
| Scientific Title | MULTICENTER PROBE STUDY-4; COMPARISON OF THE EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS |
| Date of disclosure of the study information | 2014/01/06 |
| Last modified on | 2016/07/06 09:34:33 |
* 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
MULTICENTER PROBE STUDY-4; COMPARISON OF THE EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS
Acronym
MUSCAT-4
Scientific Title
MULTICENTER PROBE STUDY-4; COMPARISON OF THE EFFECTS OF ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS
Scientific Title:Acronym
MUSCAT-4
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary, to compare the blood pressure lowering effect of Azilsartan with that of Olmesartan in the out-patients with hypertension. Secondary, to compare the effect of Azilsartan with that of Olmesartan on renal function, lipid profile, glucose metabolism and other markers 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 the clinic and home blood pressure
Key secondary outcomes
renal function (Cr, eGFR, K), u-Alb/Cr, u-Na/Cr, lipid profile (LDL-C, HDL-C, T.Cho), others markers, and final dosage of the drug
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switch the previous ARBs (Losartan, Candesartan, Valsartan, Telmisartan, Irbesartan) to Olmesartan which is allowed to increase the maximum dosage, then treat the patients for 4 months.
Interventions/Control_2
Switch the previous ARBs (Losartan, Candesartan, Valsartan, Telmisartan, Irbesartan) to Azilsartan which is allowed to increase the maximum dosage, then treat the patients for 4 months.
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 ARBs (Losartan, Candesartan, Valsartan, Telmisartan and Irbesartan) except Olmesartan for more than 3 months
Key exclusion criteria
The patients with,
1)severe renal failure (sCr>2.0mg/dl),
2)severe hepatic dysfunction (AST/ALT>100IU/l),
3)the history of severe side effect of ARB
4)pregnancy or lactation,
5)malignancy or other poor-prognosis disease,
6)those who are considered inappropriate by physician
Target sample size
70
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
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
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
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
| 2013 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 06 | Day |
Last modified on
| 2016 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014912
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
