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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000765
Receipt No. R000000917
Scientific Title BEDTIME ADMINISTRATION OF LONG-ACTING ANTIHYPERTENSIVE DRUGS RESTORES NORMAL NOCTURNAL BLOOD PRESSURE FALL IN NON-DIPPERS WITH ESSENTIAL HYPERTENSION
Date of disclosure of the study information 2007/07/13
Last modified on 2007/07/05

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Basic information
Public title BEDTIME ADMINISTRATION OF LONG-ACTING ANTIHYPERTENSIVE DRUGS RESTORES NORMAL NOCTURNAL BLOOD PRESSURE FALL IN NON-DIPPERS WITH ESSENTIAL HYPERTENSION
Acronym Timed therapy for non-dipper hypertension
Scientific Title BEDTIME ADMINISTRATION OF LONG-ACTING ANTIHYPERTENSIVE DRUGS RESTORES NORMAL NOCTURNAL BLOOD PRESSURE FALL IN NON-DIPPERS WITH ESSENTIAL HYPERTENSION
Scientific Title:Acronym Timed therapy for non-dipper hypertension
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the circadian antihypertensive efficacy of long-acting antihypertensive drugs when administration time was shifted from morning to bedtime in non-dippers.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the office and 24-hour ambulatory blood pressure, and the percentages of nocturnal decline in blood pressure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We studied Japanese adult patients with essential hypertension who had been receiving long-acting antihypertensive drugs once daily in the morning and changed medication time to bedtime in non-dippers after 24-hour ambulatory blood pressure monitoring.
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 Japanese adult patients with essential hypertension receiving antihypertensive treatment
Key exclusion criteria Patients with diabetes, renal dysfunction (serum creatinine>1.2 mg/dL), or a history of cardiovascular diseases were excluded
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Takeda
Organization Tsuchiura Kyodo General Hospital
Division name Kidney Center
Zip code
Address 11-7, Manabeshinmachi, Tsuchiura-shi, Ibaraki-ken, Japan
TEL 029-823-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Takeda
Organization Midorino Clinic
Division name Director
Zip code
Address 2526-1, Nishimura, Kutsukake, Bando-shi, Ibaraki-ken, 306-0515, Japan
TEL 0297-30-3311
Homepage URL
Email atakeda@midorino.com

Sponsor
Institute Tsuchiura Kyodo General Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2007 Year 07 Month 13 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 Among 71 patients, 36 were classified as dippers and 35 as non-dippers. After shifting administration time from morning to bedtime in 34 non-dippers, the office and 24-hour ambulatory blood pressure did not change, but the diurnal blood pressure increased and nocturnal blood pressure decreased. The percentages of nocturnal decline in systolic and diastolic blood pressure significantly increased from 2.6% to 15.5% (P<0.0001) and 5.6 % to 16.9 % (P<0.0001). Morning blood pressure at 7AM to 11AM did not increase by bedtime administration. The frequency of dippers increased from 0/34(0%) to 24/34(71%).
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 Completed
Date of protocol fixation
2003 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2003 Year 05 Month 01 Day
Last follow-up date
2005 Year 05 Month 01 Day
Date of closure to data entry
2005 Year 06 Month 01 Day
Date trial data considered complete
2005 Year 06 Month 01 Day
Date analysis concluded
2006 Year 06 Month 01 Day

Other
Other related information In treating essential hypertension patients, it is desirable to measure 24-hour ambulatory blood pressure as well as office blood pressure and to decide the administration time of long-acting antihypertensive drugs to normalize nocturnal BP fall and circadian blood pressure pattern.

Management information
Registered date
2007 Year 07 Month 05 Day
Last modified on
2007 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000917

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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