NCT00420901

Brief Summary

chronic PDE5-Inhibition improves endothelial function in diabetics

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Jan 1999

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2000

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
Last Updated

January 11, 2007

Status Verified

January 1, 2007

First QC Date

January 9, 2007

Last Update Submit

January 9, 2007

Conditions

Diabetes

Keywords

functioninhibition

Outcome Measures

Primary Outcomes (1)

  • Endothelial function responders - Improvement in endothelial function

Secondary Outcomes (1)

  • Changes in vascular inflammatory markers

Interventions

sildenafilDRUG

Eligibility Criteria

Age35 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes
  • males

You may not qualify if:

  • females, nitrate use, PDE5-Inhibitors intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele EUR

Roma, 00144, Italy

Location

MeSH Terms

Conditions

Diabetes MellitusInhibition, Psychological

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • giuseppe rosano, md

    San Raffaele EUR

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2007

First Posted

January 11, 2007

Study Start

January 1, 1999

Study Completion

February 1, 2000

Last Updated

January 11, 2007

Record last verified: 2007-01

Locations

IT(1)