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

Hypertension Clinical Trial

Official title:

Randomized, Controlled, PROBE Trial, Evaluating the Antiproteinuric Effect of Imidapril Versus Ramipril in Type 2 Diabetic Patients and Mild to Moderate Hypertension With Microalbuminuria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01230034
• Other study ID #: UNIPV001DIM2010
• Secondary ID: 2010-023332-17
• Status: Recruiting
• Phase: Phase 3
• First received: October 27, 2010
• Last updated: October 27, 2010
• Start date: October 2010
• Est. completion date: July 2011

Study information

• Verified date: October 2010
• Source: University of Pavia
• Contact: Roberto Fogari, MD
• Phone: +39 0382 526217
• Email: r.fogari[@]unipv.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Microalbuminuria
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Ramipril
pill, 5 and 10 mg/day, od, 24 weeks
• Imidapril
pill, 10 and 20 mg/day, od, 24 weeks

Locations

Country	Name	City	State
Italy	University of Pavia	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of the reduction of urinary albumin in 24 hours to the various controls		After 12 weeks from the beginning	Yes
Secondary	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	Yes