UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023369
Receipt No. R000026925
Scientific Title Blood pressure study in Japanese Parkinson's disease patients
Date of disclosure of the study information 2016/09/01
Last modified on 2016/07/28

* 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 Blood pressure study in Japanese Parkinson's disease patients
Acronym ABPM Study in Japanese PD
Scientific Title Blood pressure study in Japanese Parkinson's disease patients
Scientific Title:Acronym ABPM Study in Japanese PD
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the change in blood pressure of Japanese Parkinson disease patients. The results were compared with the clinical information of the patient.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluate the relationship between clinical information of PD patients and 24h ABPM data.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Japanese Parkinson's disease patients
1) age >=30 years,
2) Japanese PD patients who has been diagnosed by UKPDBB criteria
3) mini mental state examination score >= 23
4) the patients who their informed consent has been obtained
Key exclusion criteria 1) dementia and depression/psychiatric illness (according to DSM IV criteria),
2) all secondary causes of parkinsonism, epilepsy, history of other neurological disorders, stroke and/or brain trauma and drug or alcohol abuse.
3) diabetes mellitus, autonomic failure
Target sample size 216

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Renpei Sengoku
Organization Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name Neurology
Zip code
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL 03-3964-1141
Email renpeis@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Renpei Sengoku
Organization Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name Neurology
Zip code
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL 03-3964-1141
Homepage URL
Email renepis@gmail.com

Sponsor
Institute Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Institute
Department

Funding Source
Organization Self funding
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
2016 Year 09 Month 01 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
2016 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a Japanese multi-center study for evaluating blood pressure of Parkinson's disease patients.
We evaluate the correlation between 24h ABPM data and clinical information.

Management information
Registered date
2016 Year 07 Month 28 Day
Last modified on
2016 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026925

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.