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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025553
Receipt No. R000026046
Scientific Title Effect of dose timing of antihypertensive drug on blood pressure variability and target organ damage
Date of disclosure of the study information 2017/01/11
Last modified on 2019/03/28

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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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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