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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012768
Receipt No. 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

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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
Email 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
Email sannai@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Medicine and Clinical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.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


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