UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003914 |
|---|---|
| Receipt number | R000004663 |
| Scientific Title | Comparison of blood pressure lowering effect of amlodipine between once-a-daily administration and twice-a-daily administration |
| Date of disclosure of the study information | 2010/07/16 |
| Last modified on | 2013/02/18 09:45:00 |
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Basic information
Public title
Comparison of blood pressure lowering effect of amlodipine between once-a-daily administration and twice-a-daily administration
Acronym
Comparison of blood pressure lowering effect of amlodipine between once-a-daily administration and twice-a-daily administration
Scientific Title
Comparison of blood pressure lowering effect of amlodipine between once-a-daily administration and twice-a-daily administration
Scientific Title:Acronym
Comparison of blood pressure lowering effect of amlodipine between once-a-daily administration and twice-a-daily administration
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether there is a difference between blood pressure lowering effect of amlodipine once-a-daily administration and twice-a-daily administration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in 24 h mean blood pressure between the treatment with amlodipine 10mg once a daily and amlodipine 5mg twice a daily
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
After 2 months of treatment with amlodipine 5mg twice a daily,
the same patient will be treated with amlodipine 10mg once a daily.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Outpatients with essential hypertension who are treated with amlodipine 5mg twice a daily
Key exclusion criteria
1. Patients with secondary hypertension
2. Patients with SBP 150 mmHg or greater,or DBP 100 mmHg or greater.
3. Patients with malignant hypertension
4. Patients who were hospitalized because of stroke, myocadial infarction or vascular diseases within 6 months.
5. Patients with atrial fibrillation.
6. Patients with elevated liver enzymes. (AST or ALT is more than 2.5 times as high as upper normal limit)
7. Patients with elevated serum creatinine (2.0mg/dL or greater)
8. Pregnant or nursing women
9. Patients who are considered as inappropriate to participants for this study by attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jitsuo Higaki |
Organization
Ehime University Graduate School of Medicine
Division name
Integrated Medicine and Infomatics
Zip code
Address
Shitsukawa, Toon, Ehime 791-0295, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ehime University Graduate School of Medicine
Division name
Integrated Medicine and Infomatics
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Integrated Medicine and Infomatics, Ehime University Graduate School of Medicine
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
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
| 2010 | Year | 07 | Month | 16 | 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
| 2010 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | 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
| 2010 | Year | 07 | Month | 14 | Day |
Last modified on
| 2013 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004663
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
