UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005047
Receipt No. R000006002
Scientific Title Effect of evening regimen on blood pressure control in patients with morning hypertension
Date of disclosure of the study information 2011/02/08
Last modified on 2011/02/08

* 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 evening regimen on blood pressure control in patients with morning hypertension
Acronym Effect of evening regimen on blood pressure control in patients with morning hypertension
Scientific Title Effect of evening regimen on blood pressure control in patients with morning hypertension
Scientific Title:Acronym Effect of evening regimen on blood pressure control in patients with morning hypertension
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study was conducted to evaluate clinically effective treatment of morning hypertension
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blood pressure(On visit/Home monitoring)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In the combination therapy, either CCB or ARB was chosen. The administration after breakfast was changed into that at bedtime. Three months. Seventy patients.
Interventions/Control_2 In the combination therapy, either CCB or ARB was chosen. The administration after breakfast was changed. The dose was unchanged and given twice a day, i.e., after breakfast and at bedtime.Three months. Seventy patients.
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subjects were patients aged 40 years or older with hypertension. They were treated with CCB or ARB monotherapy or combination therapy with agents including CCB and ARB for at least 4 weeks and in whom the mean morning blood pressure at home for 5 days of one week prior to enrollment was 135/85 mmHg or higher.
Key exclusion criteria The exclusion criteria were apparently poor control of blood pressure, secondary hypertension, difficulty in walking by oneself, hemodialysis, malignant disorder and pregnancy.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuji Imai
Organization Imai Heart Clinic
Division name Director
Zip code
Address AminasuKitanoda204-1, 1077,Kitanoda, Higashi-ku, Sakai-shi, Osaka, Japan
TEL 072-235-4401
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuji Imai
Organization Imai Heart Clinic
Division name Director
Zip code
Address AminasuKitanoda204-1, 1077,Kitanoda, Higashi-ku, Sakai-shi, Osaka, Japan
TEL 072-235-4401
Homepage URL
Email imai-hc@umin.ac.jp

Sponsor
Institute Sakai Cardiovascular Clinical Conference
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
2011 Year 02 Month 08 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 Open public recruiting
Date of protocol fixation
2010 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 02 Month 08 Day
Last modified on
2011 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006002

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.