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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Samsung Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Duk Lyul Na, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01466543
First received: November 3, 2011
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Vascular Dementia
Subcortical Vascular Dementia
Drug: Zydena (Udenafil)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Zydena (Udenafil) on Cerebral Blood Flow and Peripheral Blood Viscosity in Normal and Subcortical Vascular Cognitive Impairment Subjects

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Cerebral blood flow [ Time Frame: One hour after the administration of the medication ] [ Designated as safety issue: No ]
    Measured by Near-infrared spectroscopy (NIRS)


Secondary Outcome Measures:
  • Peripheral blood viscosity [ Time Frame: One hour after the administration of the medication ] [ Designated as safety issue: No ]
    Measured from whole blood


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466543

Contacts
Contact: Hyunhee Jung, BSc 82-2-3410-6830 ext 6830 napapaya@hanmail.net
Contact: Duk L. Na, MD. PhD 82-2-3410-3599 ext 3599 dukna@naver.com

Locations
Korea, Republic of
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyunhee Jung, BSc    82-2-3410-6830 ext 6830    napapaya@hanmail.net   
Sponsors and Collaborators
Samsung Medical Center
Dong-A Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Duk L. Na, MD. PhD. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Duk Lyul Na, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01466543     History of Changes
Other Study ID Numbers: SMC 2011-05-042
Study First Received: November 3, 2011
Last Updated: November 7, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Vascular dementia
Subcortical vascular dementia
Phosphodiesterase 5
Udenafil

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014