Back to resultsEffect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity (SMCZN01)
Primary Purpose
Vascular Dementia, Subcortical Vascular Dementia
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Zydena (Udenafil)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Dementia focused on measuring Vascular dementia, Subcortical vascular dementia, Phosphodiesterase 5, Udenafil
Eligibility Criteria
Inclusion Criteria:
for Normal control group
- Normal cognition by detailed neuropsychological tests
- Brain MRI scan with no or minimal white matter hyperintensities
for Subcortical vascular mild cognitive impairment (svMCI)
- Clinical diagnosis of svMCI
- Brain MRI scan with severe white matter hyperintensities
Exclusion Criteria:
- Contraindications to phosphodiesterase type 5 (Zydena, Udenafil)
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Zydena (Udenafil)
Placebo
Arm Description
Zydena (Udenafil) 100 mg, once
placebo medication
Outcomes
Primary Outcome Measures
Cerebral blood flow
Measured by Near-infrared spectroscopy (NIRS)
Secondary Outcome Measures
Peripheral blood viscosity
Measured from whole blood
Full Information
NCT ID
NCT01466543
First Posted
November 3, 2011
Last Updated
November 7, 2011
Sponsor
Samsung Medical Center
Collaborators
Dong-A Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01466543
Brief Title
Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity
Acronym
SMCZN01
Official Title
Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity in Normal and Subcortical Vascular Cognitive Impairment Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Dong-A Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether Zydena (Udenafil) has effect on cerebral blood flow and peripheral blood viscosity in normal and subcortical vascular cognitive impairment subjects.
Detailed Description
Udenafil is a newly developed selective phosphodiesterase type 5 inhibitor (PDE5i). Since PDE5i is known to relax smooth muscle cells, it is suggested that PDE5i may dilate cerebral vessels and lead to an increase in cerebral blood flow. The main mechanism of subcortical vascular cognitive impairment are hypoperfusion of the brain. Therefore, in this study, the investigators will investigate whether Udenafil can increase cerebral blood flow and also lower peripheral blood viscosity in normal and subcortical vascular cognitive impairment subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Dementia, Subcortical Vascular Dementia
Keywords
Vascular dementia, Subcortical vascular dementia, Phosphodiesterase 5, Udenafil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zydena (Udenafil)
Arm Type
Active Comparator
Arm Description
Zydena (Udenafil) 100 mg, once
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo medication
Intervention Type
Drug
Intervention Name(s)
Zydena (Udenafil)
Other Intervention Name(s)
Zydena, Udenafil
Intervention Description
Zydena (Udenafil) 100 mg, one time
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Cerebral blood flow
Description
Measured by Near-infrared spectroscopy (NIRS)
Time Frame
One hour after the administration of the medication
Secondary Outcome Measure Information:
Title
Peripheral blood viscosity
Description
Measured from whole blood
Time Frame
One hour after the administration of the medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
for Normal control group
Normal cognition by detailed neuropsychological tests
Brain MRI scan with no or minimal white matter hyperintensities
for Subcortical vascular mild cognitive impairment (svMCI)
Clinical diagnosis of svMCI
Brain MRI scan with severe white matter hyperintensities
Exclusion Criteria:
- Contraindications to phosphodiesterase type 5 (Zydena, Udenafil)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyunhee Jung, BSc
Phone
82-2-3410-6830
Ext
6830
Email
napapaya@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Duk L. Na, MD. PhD
Phone
82-2-3410-3599
Ext
3599
Email
dukna@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk L. Na, MD. PhD.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyunhee Jung, BSc
Phone
82-2-3410-6830
Ext
6830
Email
napapaya@hanmail.net
12. IPD Sharing Statement
Learn more about this trial
Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity
We'll reach out to this number within 24 hrs