UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007701 |
|---|---|
| Receipt number | R000009054 |
| Scientific Title | The effect of AT1 receptor blocker/Ca antagonist combination drug on hypertensive patients - Effect of change in medication from AT1 receptor blocker/Ca antagonist concurrent dosage to its combination drug - |
| Date of disclosure of the study information | 2012/04/09 |
| Last modified on | 2014/10/31 08:48:13 |
* 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
The effect of AT1 receptor blocker/Ca antagonist combination drug on hypertensive patients
- Effect of change in medication from AT1 receptor blocker/Ca antagonist concurrent dosage to its combination drug -
Acronym
The effect of AT1 receptor blocker/Ca antagonist combination drug on hypertensive patients
Scientific Title
The effect of AT1 receptor blocker/Ca antagonist combination drug on hypertensive patients
- Effect of change in medication from AT1 receptor blocker/Ca antagonist concurrent dosage to its combination drug -
Scientific Title:Acronym
The effect of AT1 receptor blocker/Ca antagonist combination drug on hypertensive patients
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effect of AT1 receptor blocker/Ca antagonist combination drug on hypertensive patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Exchange to combination drug
Interventions/Control_2
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients who are medicated with AT1 receptor blocker and Ca antagonist
Key exclusion criteria
The exclusion criteria were an age >75 years, current history of myocardial infarction and/or cerebral stroke, renal failure, abnormal liver or muscle enzymes (ALT>100, ALT>100), applied for other clinical trial within 3 months, expectant mother, lactating woman, inappropriate patients judged by the physician in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Takemoto |
Organization
Chiba University Hospital
Division name
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL
043-222-7171
minoru.takemoto@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Takemoto |
Organization
Chiba University Hospital
Division name
Department of Medicine, Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
minoru.takemoto@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
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
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
| 2012 | Year | 04 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 09 | Day |
Last modified on
| 2014 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009054
