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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002626
Receipt No. 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

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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
Email 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
Email jimukyoku@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003200

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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