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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023332-17 | EudraCT Number |
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Numerous clinical and experimental data show that the elective treatment of diabetic nephropathy should be based on drugs that inhibit the renin-angiotensin system (RAS). Albuminuria is a marker of risk not only renal but also cardiovascular and diabetic patients with concomitant non-diabetic nephropathy, on the other hand, drugs blocking the renin-angiotensin system available so far, namely ACE inhibitors and angiotensin antagonists II have proven effective in reducing proteinuria in power even if different therapeutic drug to drug. ACE inhibitors are one of the most known and used treatment options for blocking the renin-angiotensin system in patients with microalbuminuria. Drugs such as enalapril, lisinopril and ramipril are standard therapy in diabetic patients with micro or macroalbuminuria. However, it is still unclear whether their efficacy is, from this point of view, the same or varies from drug to drug. This is particularly true in the diabetic microalbuminuria, a condition in which there is sufficient documentation to prove that ramipril is effective. The main objective of this study was to assess the magnitude and trend of the time and to the antiproteinuric effect of antihypertensive 10-20mg/die imidapril versus ramipril 5-10 mg / day in hypertensive patients with type 2 diabetes and microalbuminuria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imidapril | Experimental | 10 and 20 mg/day, pill |
|
| Ramipril | Active Comparator | 5 and 10 mg/day, pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramipril | Drug | pill, 5 and 10 mg/day, od, 24 weeks |
| |
| Imidapril |
| Measure | Description | Time Frame |
|---|---|---|
| Size of the reduction of urinary albumin in 24 hours to the various controls | After 12 weeks from the beginning |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Size of the reduction of mean 24-hour average daytime and nighttime average. 2. Size of the reduction of central blood pressure. 3. Magnitude of changes in plasma concentrations of angiotensin II, bradykinin and BNP after 24 weeks of treatment. | After 12 weeks from the beginning |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Fogari, MD | Contact | +39 0382 526217 | r.fogari@unipv.it | |
| Giuseppe Derosa, MD | Contact | +39 0382 502614 | giuseppe.derosa@unipv.it |
| Name | Affiliation | Role |
|---|---|---|
| Roberto Fogari, MD | University of Pavia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pavia | Recruiting | Pavia | 27100 | Italy |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D017257 | Ramipril |
| C065166 | imidapril |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
pill, 10 and 20 mg/day, od, 24 weeks |
|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |