UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002626 |
|---|---|
| Receipt number | R000003200 |
| Scientific Title | Study of clinical utility of amlodipine OD 5mg tablet Chemiphar to the patients with essential hypertension |
| Date of disclosure of the study information | 2009/10/30 |
| Last modified on | 2016/02/02 15:55:50 |
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Basic information
Public title
Study of clinical utility of amlodipine OD 5mg tablet Chemiphar to the patients with essential hypertension
Acronym
Study of clinical utility of amlodipine OD 5mg tablet Chemiphar to the patients with essential hypertension
Scientific Title
Study of clinical utility of amlodipine OD 5mg tablet Chemiphar to the patients with essential hypertension
Scientific Title:Acronym
Study of clinical utility of amlodipine OD 5mg tablet Chemiphar to the patients with essential hypertension
Region
| Japan |
Condition
Condition
essential hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effectiveness and safety of generic product (amlodipine OD 5mg tablet Chemiphar) of amlodipine besylate in patients with essential hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sitting diastolic blood pressure at trough (variation from the onset of the observation to the end of the observation period)
Key secondary outcomes
Sitting systolic blood pressure at trough (variation from the onset of the observation to the end of the observation period)
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
he amlodipine OD5mg tablet chemiphar for 8 weeks
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
At the time of obtaining consent
take starter drugs of amlodipine besylate for treatment of mild or moderate symptoms of essential hypertension
Norvasc 5mg tablet, the OD 5mg tablet (Pfizer Inc.), Amlodin 5mg tablet, the OD 5mg tablet (Dainippon Sumitomo Pharrma Co., Ltd.)
ages of 20 years old and over
has ability to understand the contents the clinical research and to comply with it
provide written consent of participation in clinical research
for women who has possibilities of pregnancy (in premenopausal women, those how have not been sterilized), the person agrees to the implementation of appropriate contraception through clinical research
Key exclusion criteria
upon selection of cases the following conditions are not eligible for this clinical research. The patients who are found to be excluded should be immediately discontinued the inistration of trial drugs and given appropriate treatment or switched to other drugssecondary hypertension severe hypertension systolic blood pressure above 180mmHgor diastolic blood pressure above 110mmHg or malignant hypertension patients with following circulatory diseases or symptomsheart disease myocardial infarction onset within 24 weeks prior to the consent coronary revascularization onset within 24 weeks prior to the consent valve stenosis atrial fibrillation cerebrovasculardisease stroke cerebral hemorrhage onset within 24 weeks prior to the consenttransient ischemic attack onset within 24 weeks prior to the consent vasculardiseasearteriosclerosis obliterans with symptoms such as intermittent claudication advancedhypertensive retinopathy papillary edema or hemorrhage leaching first diagnosis within 24 weeks prior to the consentTaking 3 or more types of antihypertensive drugs before obtaining consentclinically apparentliverdisorder diseases cf ast altlevel exceed 2.5 timesor above of standardclinically apparent kidney disorder diseases cf serum creatinine value exceeds 2.0mgdl or aboveuncontrolled diabetes cfHba1C10 or aboveHistory of hypersensitivity or allergy to amlodipine besylatehistory of hypersensitivity or allergy to drugshistory of alcoholism or drug abusepatients who meet exclusion criteria need to be treated prohibited combinations of drug and or therapy women who are pregnant or nursing
participation in other clinical research postmarketing trials and other related tests wihtin 90 days prior to the relevant clinical research.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
Address
6F da Vinci A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1590
jimukyoku@mai.souken-r.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Mitsuda |
Organization
SOUKEN Co., Ltd
Division name
SMO division
Zip code
Address
3F da Vinci A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
050-5511-6111
Homepage URL
jimukyoku@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
Nihon Pharmaceutical Industry Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
SOUKEN Co., Ltd
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
芝パレスクリニック
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 30 | 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
| 2009 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | 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
| 2009 | Year | 10 | Month | 14 | Day |
Last modified on
| 2016 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003200
