UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective study on effectiveness of combination drugs for hypertension - Consideration on blood-pressure control before and after switch from concomitant use of single drugs to combination drug -
Title of the study (Brief title)	Retrospective study on effectiveness of combination drugs for hypertension
Region	Japan

Condition
Condition	hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Recently, a lot of combination drugs have been approved in Japan, which included more than 2 active ingredients. It is considered that combination drug contributes improvement of patient compliance, but there is no objective data. This study is to provide some evidence for insights on effectiveness of combination drugs through retrospective evaluation for blood-pressure control on patients with hypertension before and after switching from concomitant use of single drugs to combination drug.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of blood-pressure before and after switching concomitant use of single drugs to combination drug
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients who are treated with concomitant use of single hypertension drugs for 6 months or more 2)Patients who are treated with hypertension combination drug for 6 months or more, which includes same active ingredients treated in the previous concomitant use of single drugs
Key exclusion criteria	None
Target sample size	100

Research contact person
Name of lead principal investigator	Takao Aoyama
Organization	Tokyo University of Science
Division name	Faculty of Pharmaceutical Sciences
Address	2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL	04-7121-4134
Email	t-aoyama@rs.noda.tus.ac.jp

Public contact
Name of contact person	Takao Aoyama
Organization	Tokyo University of Science
Division name	Faculty of Pharmaceutical Sciences
Address	2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL	04-7121-4134
Homepage URL
Email	t-aoyama@rs.noda.tus.ac.jp

Sponsor
Institute	Laboratory of pharmacotherapeutics, Tokyo University of Science
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kan-Etsu hospital
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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 20 Day
Anticipated trial start date	2014 Year 03 Month 21 Day
Last follow-up date
Date of closure to data entry	2014 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Ongoing data analysis

Management information
Registered date	2016 Year 04 Month 16 Day
Last modified on	2017 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025224