| Trial ID: | L3511 |
| Source ID: | NCT01743014
|
| Associated Drug: |
Ramipril
|
| Title: |
Ramipril and Clopidogrel in Oxidative Stress, Vascular Inflammation and Endothelial Dysfunction in Type 2 Diabetes and Diabetic Nephropathy
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Type 2|Diabetic Nephropathy|Vascular Disease
|
| Interventions: |
DRUG: Ramipril|DRUG: Clopidogrel
|
| Outcome Measures: |
Primary: Changes in Asymmetric dimethylarginine (ADMA) blood levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy, The primary aim is to investigate the effect of the combined treatment with ramipril and clopidogrel versus ramipril monotherapy in ADMA as biomarker of endothelial dysfunction., Baseline to week 12 and week 14 to week 26|Changes in High-sensitivity C-reactive protein (HsCRP) blood levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy, The primary aim is to investigate the effect of the combined treatment with ramipril and clopidogrel versus ramipril monotherapy in hsCRP as biomarker of vascular inflammation, Baseline to week 12 and week 14 to week 26|Changes in soluble CD40 Ligand (sCD40L)blood levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy, The primary aim is to investigate the effect of the combined treatment with ramipril and clopidogrel versus ramipril monotherapy in soluble CD40 Ligand as biomarker of vascular inflammation., Baseline to week 12 and week 14 to week 26|Changes in urine 8-isoprostane-F2 levels after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy, The primary aim is to investigate the effect of the combined treatment with ramipril and clopidogrel versus ramipril monotherapy in urine 8-isoprostane-F2 as biomarker of oxidative stress., Baseline to week 12 and week 14 to week 26|Reduction in albumine to creatine ratio after the combined treatment with ramipril and clopidogrel compared with ramipril monotherapy, The primary aim is to investigate the effect of the combined treatment with ramipril and clopidogrel versus ramipril monotherapy in albumine to creatine ratio as an index of cardiovascular disease, Baseline to week 12 and week 14 to week 26 | Secondary: Changes in ADMA blood levels after treatment with ramipril, Evaluation of the effect of ramipril, as antihypertensive therapy, in endothelial dysfunction in patients with diabetes mellitus type 2 and diabetic nephropathy, baseline to week 26|Increase of Glomerular Filtration Rate (GFR) after combined treatment with ramipril and clopidogrel and after ramipril monotherapy, baseline to week 12 and week 14 to week 26|Change from baseline in carotid intima-media thickness after combined therapy with ramipril and clopidogrel and after ramipril monotherapy, baselibe to week 12 and week 14 to week 26
|
| Sponsor/Collaborators: |
Sponsor: AHEPA University Hospital | Collaborators: Aristotle University Of Thessaloniki
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2012-07
|
| Completion Date: |
2015-07
|
| Results First Posted: |
|
| Last Update Posted: |
2012-12-06
|
| Locations: |
AHEPA University Hospital, Thessaloniki, 546 36, Greece|Aristotle University of Thessaloniki/ AHEPA University Hospital, Thessaloniki, Greece
|
| URL: |
https://clinicaltrials.gov/show/NCT01743014
|
