UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019759 |
|---|---|
| Receipt number | R000022820 |
| Scientific Title | Effect of ATEDIO Combination Tab. on hypertension (Retrospective research study) |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2017/02/08 11:21:18 |
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Basic information
Public title
Effect of ATEDIO Combination Tab. on hypertension
(Retrospective research study)
Acronym
Hypotensive action
(Retrospective research study)
Scientific Title
Effect of ATEDIO Combination Tab. on hypertension
(Retrospective research study)
Scientific Title:Acronym
Hypotensive action
(Retrospective research study)
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Actual clinical hypotensive action
Of ATEDIO Combination Tab.
(Retrospective research study)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in blood pressure
Key secondary outcomes
Change in pulse rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
From May 2014 until 2015, the end of June, it has a chronic treatment of ATEDIO Combination Tab. and continue taking more than 8 weeks.
(Hypertensive patients over 20 years of age)
Key exclusion criteria
1. Patients with a history of hypersensitivity for this medications
2. Women who may possibly be pregnant or is pregnant
3. Diabetic patient who has a treatment of Aliskiren
4. Patient who is a treatment-resistant hypertension
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Ando |
Organization
Kan-etsu Central Hospital
Division name
Cardiology
Zip code
Address
71 Kitahara, Takasakisi, Gunma
TEL
027-373-5115
info@kan-etsu-hospital.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Ando |
Organization
Kan-etsu Central Hospital
Division name
Cardiology
Zip code
Address
71 Kitahara, Takasakisi, Gunma
TEL
027-373-5115
Homepage URL
info@kan-etsu-hospital.com
Sponsor or person
Institute
Kan-etsu Central Hospital
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO PHARMACEUTICALS 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
医療法人 関越中央病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 16 | 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
| 2015 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Information about the hypotensive action under real clinical treatments of Atedio Combination Tablets has not been provided to the physicians. To investigate the hypotensive effects of Atedio Combination Tablets under real clinical treatments, and to publish the informations promptly to the physicians by the medical journal. This study is carried out on the basis of the commissioned research contract with the medical corporation Kanetsu Central Hospital and Ajinomoto Pharmaceutical Co., Ltd..
Management information
Registered date
| 2015 | Year | 11 | Month | 12 | Day |
Last modified on
| 2017 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022820
