UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002144 |
|---|---|
| Receipt number | R000002619 |
| Scientific Title | A clinical study of amlodipine besilate OD tablet for the essential hypertension patients - Comparative study on the antihypertensive effect and the safety between a bland drug and a generic drug - |
| Date of disclosure of the study information | 2009/07/01 |
| Last modified on | 2009/12/24 15:09:16 |
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Basic information
Public title
A clinical study of amlodipine besilate OD tablet for the essential hypertension patients
- Comparative study on the antihypertensive effect and the safety between a bland drug and a generic drug -
Acronym
A comparative study on the efficacy and safety between a bland drug and a generic drug of the amlodipine besilate OD tablet
Scientific Title
A clinical study of amlodipine besilate OD tablet for the essential hypertension patients
- Comparative study on the antihypertensive effect and the safety between a bland drug and a generic drug -
Scientific Title:Acronym
A comparative study on the efficacy and safety between a bland drug and a generic drug of the amlodipine besilate OD tablet
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Randomized, open-label, and comparative study on the antihypertensive effect and safety between a bland drug and a generic drug of the amlodipine besilate OD tablet in essential hypertension patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of diastolic blood pressure from baseline in trough and sitting position
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
amlodipine besilate OD tablet (a generic drug)
2.5 mg or 5 mg
Interventions/Control_2
amlodipine besilate OD tablet (a bland drug)
2.5 mg or 5 mg
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Essential hypertension Grade I and II patients diagnosed according to the Hypertension Treatment Guideline 2009 of the Japanese Society of Hypertension
2.Patients who have been taking amlodipine besilate regular tablets (2.5 or 5 mg, single daily) for more than 8 weeks
3.Patients whose diastolic blood pressure has been kept between >=70 mmHg and <110 mmHg for 2 months
4.Patients whose written consent is obtained at age 20 years or over, etc
Key exclusion criteria
1.Patients who take calcium channel blocker except amlodipine besilate regular tablets
2.Grade III hypertension
3.Secondary hypertension
4.Malignant hypertension
5.Patients with hepatic dysfunction or severe hepatic disease
6.Patients with a past history of hypersensitiveness to the study drug
7.Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant during the study period
8.Patients with malignant cancer
9.Patients with a past history of drug abuse or drug addiction
10.Patients who have attended toany clinical trials within 12 months before the start of the administration, etc
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Higuchi |
Organization
Nagano Kidney Evaluation Association (NKEA)
Division name
Nephrology Internal Medicine, Shinshu University School of Medicine
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagano Kidney Evaluation Association (NKEA)
Division name
Nephrology Internal Medicine, Shinshu University School of Medicine
Zip code
Address
2-17-5 Tsukama, Matsumoto, Nagano, 390-0821 JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Nagano Kidney Evaluation Association (NKEA)
Institute
Department
Personal name
Funding Source
Organization
Nichi-Iko Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.shizenkagaku.com/igakutoyakugaku/
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 | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 10 | 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 | 06 | Month | 30 | Day |
Last modified on
| 2009 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002619
