UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025553
Receipt number 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 18:17:26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Jichi Medical School

Institute

Department

Personal name



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

Value
https://center6.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