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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013240
Receipt No. R000015450
Scientific Title The effect of intravitreal ranibizumab on systemic hypertension in age-related macular degeneration patients with hypertension.
Date of disclosure of the study information 2014/02/27
Last modified on 2014/02/24

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Basic information
Public title The effect of intravitreal ranibizumab on systemic hypertension in age-related macular degeneration patients with hypertension.
Acronym The effect of intravitreal ranibizumab on systemic hypertension in age-related macular degeneration patients with hypertension.
Scientific Title The effect of intravitreal ranibizumab on systemic hypertension in age-related macular degeneration patients with hypertension.
Scientific Title:Acronym The effect of intravitreal ranibizumab on systemic hypertension in age-related macular degeneration patients with hypertension.
Region
Japan

Condition
Condition age-related macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effect of intravitreal ranibizumab administration on systemic blood pressure levels in hypertensive patients with systolic blood pressure of >140mmHg and diastolic blood pressures of >90mmHg (grade 1 hypertension according to WHO-ISH)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes systemic blood pressure
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with age related macular degeneration and hypertension (systolic blood pressure of >140mmHg and diastolic blood pressure of >90mmHg at baseline measurement), planned to receive treatment with intravitreal ranibizumab at Tokushima University Hospital.
Key exclusion criteria Patients refused entry into the study.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Mitamura
Organization Institute of Health Biosciences, The University of Tokushima Graduate School
Division name Department of Ophthalmology
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima 770-8503, Japan
TEL 088-633-7163
Email katome@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Katome
Organization Institute of Health Biosciences, The University of Tokushima Graduate School
Division name Department of Ophthalmology
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima 770-8503, Japan
TEL 088-633-7163
Homepage URL
Email katome@tokushima-u.ac.jp

Sponsor
Institute Institute of Health Biosciences, The University of Tokushima Graduate School
Institute
Department

Funding Source
Organization Novartis
Organization
Division
Category of Funding Organization Profit organization
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
2014 Year 02 Month 27 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 Enrolling by invitation
Date of protocol fixation
2013 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Blood pressure measurements are performed in patients with age related macular degeneration and hypertension receiving intravitreal injection of ranibizumab, in every patient visits (just before first ranibizumab injection as baseline, month 1, 2, and 3).

Management information
Registered date
2014 Year 02 Month 24 Day
Last modified on
2014 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015450

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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