Antiproteinuric Effect of Imidapril Versus Ramipril in Type 2 Diabetic and Hypertensive Patients With Microalbuminuria

University of Pavia

Status and phase: Unknown; Phase 3

Conditions: Hypertension; Type 2 Diabetes Mellitus; Microalbuminuria

Treatments: Drug: Ramipril; Drug: Imidapril

Study type: Interventional

Funder types: Other

Identifiers

NCT01230034

2010-023332-17 (EudraCT Number)

UNIPV001DIM2010

Details and patient eligibility

About

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.

Enrollment: 206 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Blood pressure> 130/80 ≤ 170/100 mmHg at the end of the period of wash-out
• Type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c <7%)
• Microalbuminuria in the upper range of normal (> 150 <300 mg/24 h)

Exclusion criteria

• Pregnancy, lactation or women of childbearing age.
• Inability to stop treatment in place for a few days during the wash-out.
• Sitting diastolic blood pressure> 100 mmHg or systolic pressure> 170 at the end of the wash-out.
• History of hypertensive encephalopathy or cerebrovascular accident within 12 months prior.
• Secondary hypertension.
• Heart failure
• Acute myocardial infarction; angina pectoris
• Liver and kidney dysfunction
• Known hypersensitivity to ACE inhibitors
• All other physiological or pathological condition that the physician may affect the evaluation of the parameters under study or interfere with the proper conduct of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

Imidapril

Experimental group

Description:

10 and 20 mg/day, pill

Treatment:

Drug: Imidapril

Ramipril

Active Comparator group

Description:

5 and 10 mg/day, pill

Treatment:

Drug: Ramipril