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 |
Study of clinical utility of amlodipine OD 5mg tablet Chemiphar to the patients with essential hypertension
Study of clinical utility of amlodipine OD 5mg tablet Chemiphar to the patients with essential hypertension
Study of clinical utility of amlodipine OD 5mg tablet Chemiphar to the patients with essential hypertension
Study of clinical utility of amlodipine OD 5mg tablet Chemiphar to the patients with essential hypertension
Japan |
essential hypertension
Cardiology |
Others
NO
To evaluate effectiveness and safety of generic product (amlodipine OD 5mg tablet Chemiphar) of amlodipine besylate in patients with essential hypertension
Safety,Efficacy
Pragmatic
Not applicable
Sitting diastolic blood pressure at trough (variation from the onset of the observation to the end of the observation period)
Sitting systolic blood pressure at trough (variation from the onset of the observation to the end of the observation period)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
he amlodipine OD5mg tablet chemiphar for 8 weeks
20 | years-old | <= |
70 | years-old | >= |
Male and Female
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
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.
50
1st name | |
Middle name | |
Last name | Takashi Koikeda |
Shiba Palace Clinic
Chair
6F da Vinci A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
03-5408-1590
jimukyoku@mai.souken-r.com
1st name | |
Middle name | |
Last name | Tohru Mitsuda |
SOUKEN Co., Ltd
SMO division
3F da Vinci A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
050-5511-6111
jimukyoku@mail.souken-r.com
Shiba Palace Clinic
Nihon Pharmaceutical Industry Co.,Ltd.
Profit organization
Japan
SOUKEN Co., Ltd
NO
芝パレスクリニック
2009 | Year | 10 | Month | 30 | Day |
Unpublished
Completed
2009 | Year | 09 | Month | 03 | Day |
2009 | Year | 10 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2009 | Year | 10 | Month | 14 | Day |
2016 | Year | 02 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003200