UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013240 |
|---|---|
| Receipt number | 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 16:36:45 |
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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
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
katome@tokushima-u.ac.jp
Sponsor or person
Institute
Institute of Health Biosciences, The University of Tokushima Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015450
