| Trial ID: | L2553 |
| Source ID: | NCT02219646
|
| Associated Drug: |
Vardenafil
|
| Title: |
Diabetes & Vardenafil
|
| Acronym: |
DiVa
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)|Endothelial Dysfunction|Erectile Dysfunction
|
| Interventions: |
DRUG: Vardenafil|DRUG: Placebo
|
| Outcome Measures: |
Primary: Endothelin-1, change in serum endothelin 1 concentration, "6 months" | Secondary: Flow Mediated Dilation, Change of flow mediated dilation evaluated by ultrasonography at brachial artery, "baseline"|Flow Mediated dilation (FMD), Change of FMD levels, "6 months"|Flow Mediated Dilation, Change of FMD levels, "One year" | Other: carotid Intima Media Thickness, Change of ultrasonographic evaluation of intima-media thickness at both right and left carotid arteries, "baseline"|carotid Intima Media Thickness (IMT), Change in IMT levels, "6 months"|carotid Intima Media Thickness, change in IMT levels, "One year"
|
| Sponsor/Collaborators: |
Sponsor: Azienda USL Modena
|
| Gender: |
MALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
54
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
|
| Start Date: |
2010-03
|
| Completion Date: |
2014-02
|
| Results First Posted: |
|
| Last Update Posted: |
2014-08-19
|
| Locations: |
Unit of Endocrinology Azienda USL, Modena, 41126, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT02219646
|
