UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003847 |
|---|---|
| Receipt number | R000004632 |
| Scientific Title | Effect of AT1 receptor blocker plus low-dose diuretics and Ca blocker on home blood pressure |
| Date of disclosure of the study information | 2010/06/30 |
| Last modified on | 2010/06/30 10:48:33 |
* 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 AT1 receptor blocker plus low-dose diuretics and Ca blocker on home blood pressure
Acronym
PLES TRIAL
Scientific Title
Effect of AT1 receptor blocker plus low-dose diuretics and Ca blocker on home blood pressure
Scientific Title:Acronym
PLES TRIAL
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the effect of AT1 blocker plus low-dose diuretics and AT1 blocker plus Ca antagonist on home blood pressure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Morning blood pressure
Key secondary outcomes
Evening blood pressure
Office blood pressure
Side effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Preminent treated group
(Losartan50mg+Hydrochrolthiazide12.5mg)
Interventions/Control_2
Olmesartan 20mg+Calblock16mg
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hypertension over 140/90 mmHg at Office
Key exclusion criteria
Secondary Hypertension
CVD within 6 months
Ischemic heart disease within 6months
Heart failure over NYHA III
Severe Liver disease
Severe Kidney disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetomo Nakamoto |
Organization
Saitama Medical University
Division name
General Internal Medicine
Zip code
Address
38Morohongo, Moroyamamachi, Iruma-gun, Saitama350-0451, Japan
TEL
049-276-1667
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetomo Nakamoto |
Organization
Saitama Medical University
Division name
General Internal Medicine
Zip code
Address
38Morohongo, Moroyamamachi, Iruma-gun, Saitama350-0451, Japan
TEL
049-276-1667
Homepage URL
nakamo_h@saitama-med.ac.jp
Sponsor or person
Institute
Department of General Internal Medicine, Saitama Medical School
Institute
Department
Personal name
Funding Source
Organization
Department of General Internal Medicine, Saitama Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
埼玉医科大学病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 30 | Day |
Last modified on
| 2010 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004632
