UMIN-CTR Clinical Trial

Basic information
Public title	Effect of dose timing of antihypertensive drug on blood pressure variability and target organ damage
Acronym	TIMING study
Scientific Title	Effect of dose timing of antihypertensive drug on blood pressure variability and target organ damage
Scientific Title:Acronym	TIMING study
Region	Japan

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

Objectives
Narrative objectives1	We investigate how dose timing(morning or evening) of antihypertensive drug effect blood pressure variability and target organ damage (CAVI: Cardio Ankle Vascular Index) in adult hypertensive patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CAVI( Cardio Ankle Vascular Index) in 6 mounts after randamization
Key secondary outcomes	Variability of blood pressure Cardiovascular event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	After getting an informed consent, patients are randamized into two groups (morning or evening). Controle 1 is morning group. After 6 mounts intervention, we will follow up the outcome for 7 years.
Interventions/Control_2	After getting an informed consent, patients are randamized into two groups (morning or evening). Controle 2 is evening group. After 6 mounts intervention, we will follow up the outcome for 7 years.
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Hepertensive patients having antihypertensive drugs and over 135/85mmHg on morning blood pressure 2. Over 30 years old male and female
Key exclusion criteria	1) Chronic kidney disease patients under hemodialysis 2) Other severe patients( ex: terminal cancer, active collagen disease) 3) alcohol abuser 4) drug abuser 5) disability of independent gait 6) patients who can not get informed consent from themselves 7) inappropriate patients judged by doctors
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kazuomi Kario
Organization	Jichi Medical School
Division name	Cardiology
Zip code
Address	3311-1 Yakushiji Shimotsuke-city Tochigi-prefecture Japan
TEL	0285-44-2111
Email	kkario@jichi.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Kei Sato
Organization	Mitsui Memorial Hospital
Division name	Cardiology
Zip code
Address	1 Kanda Izumicho,Chiyoda-ku,Tokyo 101-8643, Japan
TEL	03-3862-9111
Homepage URL
Email	m02045ks@jichi.ac.jp

Sponsor
Institute	Jichi Medical School
Institute
Department

Funding Source
Organization	Jichi Medical School
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 11 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	Terminated
Date of protocol fixation	2016 Year 12 Month 02 Day
Date of IRB	2017 Year 01 Month 10 Day
Anticipated trial start date	2017 Year 01 Month 11 Day
Last follow-up date	2025 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 05 Day
Last modified on	2019 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026046