UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of ATEDIO Combination Tab. on hypertension (Retrospective research study)
Title of the study (Brief title)	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	Toshiaki Ando
Organization	Kan-etsu Central Hospital
Division name	Cardiology
Address	71 Kitahara, Takasakisi, Gunma
TEL	027-373-5115
Email	info@kan-etsu-hospital.com

Public contact
Name of contact person	Toshiaki Ando
Organization	Kan-etsu Central Hospital
Division name	Cardiology
Address	71 Kitahara, Takasakisi, Gunma
TEL	027-373-5115
Homepage URL
Email	info@kan-etsu-hospital.com

Sponsor
Institute	Kan-etsu Central Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022820