UMIN-CTR Clinical Trial

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

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008121
Receipt No. R000009562
Official scientific title of the study Effect of valsartan on natriuresis and blood pressure
Date of disclosure of the study information 2012/06/15
Last modified on 2018/10/31

* 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
Official scientific title of the study Effect of valsartan on natriuresis and blood pressure
Title of the study (Brief title) VENUS study
Region
Japan

Condition
Condition Hypertensive patients with office blood pressure moretha 140/90mmHg
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of valsartan on natrium excretion and blood pressure, and brain, kidney and cardiovascular events
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Urinary NaCL excretion
Blood pressure
Key secondary outcomes Brain event
Kidney event
Cardiovascular event

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 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 Valsartan
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hypertensive patients with office blood pressure more than 140/90mmHg
Key exclusion criteria Patients undergoing hemodialysis, Pregnant patients, Patients receiving diuretics, Patients whom the doctor judged inappropriate to enroll,
Target sample size 200

Research contact person
Name of lead principal investigator Shinya Minatoguchi
Organization Gifu University
Division name Department of Cardiology
Address Yanagido 1-1, Gifu city, Gifu
TEL 058-230-6520
Email

Public contact
Name of contact person Takuma Aoyama
Organization Gifu University
Division name Department of Cardiology
Address Yanagido 1-1, Gifu city, Gifu
TEL 058-230-6523
Homepage URL
Email TKMAOYAMA@aol.com

Sponsor
Institute Gifu University
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 Gifu University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 岐阜大学病院

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 15 Day

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 04 Month 01 Day
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 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

Management information
Registered date
2012 Year 06 Month 07 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009562


Contact us.