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Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity

NCT ID: NCT01466543

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Vascular Dementia Subcortical Vascular Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Zydena (Udenafil)

Zydena (Udenafil) 100 mg, once

Group Type ACTIVE_COMPARATOR

Zydena (Udenafil)

Intervention Type DRUG

Zydena (Udenafil) 100 mg, one time

Placebo

placebo medication

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Zydena (Udenafil)

Zydena (Udenafil) 100 mg, one time

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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Zydena Udenafil

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Duk Lyul Na

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duk L. Na, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Hyunhee Jung, BSc

Role: CONTACT

[email protected]
82-2-3410-6830 ext. 6830

Duk L. Na, MD. PhD

Role: CONTACT

[email protected]
82-2-3410-3599 ext. 3599

Facility Contacts

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Hyunhee Jung, BSc

Role: primary

[email protected]
82-2-3410-6830 ext. 6830

Other Identifiers

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SMC 2011-05-042

Identifier Type: -

Identifier Source: org_study_id