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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003914
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Integrated Medicine and Infomatics, Ehime University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.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


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