UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006412 |
|---|---|
| Receipt number | R000006468 |
| Scientific Title | Adherence to the ARB/CCB fixed dose combination tablets and ARB/CCB concomitant therapy, a randomized parallel trial on efficacy and safety |
| Date of disclosure of the study information | 2011/09/27 |
| Last modified on | 2020/03/12 10:45:32 |
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Basic information
Public title
Adherence to the ARB/CCB fixed dose combination tablets and ARB/CCB concomitant therapy, a randomized parallel trial on efficacy and safety
Acronym
Adherence to the ARB/CCB efficacy and safety study of both fixed dose combination tablets and concomitant usage.
Scientific Title
Adherence to the ARB/CCB fixed dose combination tablets and ARB/CCB concomitant therapy, a randomized parallel trial on efficacy and safety
Scientific Title:Acronym
Adherence to the ARB/CCB efficacy and safety study of both fixed dose combination tablets and concomitant usage.
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hypertension ARB / CCB combination tablet clinical usefulness, ARB and CCB parallel group randomized trials comparing combination therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
adherence
Key secondary outcomes
blood pressure, pulse rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ARB / CCB combination tablet therapy administered for 2 months
Interventions/Control_2
CCB and ARB therapy is administered two months with a combination of antihypertensive therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(a) Currently, ARB and CCB in combination with high blood pressure patients
(b) Patients with hypertension who are taking a combination tablet weight of each standard internal use
(c) Patients over 20 years of age at the time of obtaining informed consent
(d) Patients who obtained consent in writing of the study participants
Key exclusion criteria
(a) ARB, CCB administration of drugs contraindicated in patients with hypertension and other symptoms (irritability, and pregnant women)
(b) Patients deemed unsuitable for the doctor to conduct a study
Target sample size
440
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuki Kihara |
Organization
Hiroshima University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5540
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Ishida |
Organization
Hiroshima University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5540
Homepage URL
ishidat@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiroshima Prefectural Hosp., Saiseikai Hiroshima Hosp., Saiseikai Kure Hosp., Kure Kyosai Hosp., Hiroshima City Hosp., JA Onomichi General Hosp., and other 40 Hospitals/Clinics
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
広島大学病院 他４６施設
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 27 | 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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 27 | Day |
Last modified on
| 2020 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006468
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
