Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity (SMCZN01)

November 7, 2011 updated by: Duk Lyul Na, Samsung Medical Center

Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity in Normal and Subcortical Vascular Cognitive Impairment Subjects

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Duk L. Na, MD. PhD
  • Phone Number: 3599 82-2-3410-3599
  • Email: dukna@naver.com

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Zydena (Udenafil)
Zydena (Udenafil) 100 mg, once
Drug: Zydena (Udenafil)
Zydena (Udenafil) 100 mg, one time
Other Names:
  • Zydena
  • Udenafil
Placebo Comparator: Placebo
placebo medication
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral blood flow
Time Frame: One hour after the administration of the medication
Measured by Near-infrared spectroscopy (NIRS)
One hour after the administration of the medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral blood viscosity
Time Frame: One hour after the administration of the medication
Measured from whole blood
One hour after the administration of the medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Dong-A Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Duk L. Na, MD. PhD., Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

November 3, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Estimate)

November 8, 2011

Last Update Submitted That Met QC Criteria

November 7, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2011-05-042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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