UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Blood pressure study in Japanese Parkinson's disease patients
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Name of lead principal investigator	Renpei Sengoku
Organization	Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name	Neurology
Address	35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL	03-3964-1141
Email	renpeis@gmail.com

Public contact
Name of contact person	Renpei Sengoku
Organization	Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name	Neurology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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