essential hypertension
Conditions
Interventions
he amlodipine OD5mg tablet chemiphar for 8 weeks
Sponsors
Shiba Palace Clinic
SOUKEN Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sitting diastolic blood pressure at trough (variation from the onset of the observation to the end of the observation period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Sitting systolic blood pressure at trough (variation from the onset of the observation to the end of the observation period) | — |
Countries
Japan
Contacts
Public ContactTohru Mitsuda
SOUKEN Co., Ltd SMO division
Outcome results
None listed