UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000765 |
|---|---|
| Receipt number | 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 22:08:16 |
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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
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
atakeda@midorino.com
Sponsor or person
Institute
Tsuchiura Kyodo General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000917
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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