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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Type 2 Diabetes Mellitus; Microalbuminuria
• Intervention / Treatment: Drug: Imidapril; Drug: Ramipril

• Study Type: Interventional
• Enrollment (Anticipated): 206
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • University of Pavia
    • Contact: Giuseppe Derosa, MD; Phone Number: +39 0382 526217; Email: giuseppe.derosa@unipv.it
    • Sub-Investigator: Giuseppe Derosa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imidapril; 10 and 20 mg/day, pill	Drug: Imidapril; pill, 10 and 20 mg/day, od, 24 weeks
Active Comparator: Ramipril; 5 and 10 mg/day, pill	Drug: Ramipril; pill, 5 and 10 mg/day, od, 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Size of the reduction of urinary albumin in 24 hours to the various controls	After 12 weeks from the beginning

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Study Director: Roberto Fogari, MD, University of Pavia

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: October 27, 2010
• First Submitted That Met QC Criteria: October 27, 2010
• First Posted (Estimate): October 28, 2010

Study Record Updates

• Last Update Posted (Estimate): October 28, 2010
• Last Update Submitted That Met QC Criteria: October 27, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Imidapril, Ramipril, Hypertension, Type 2 diabetes mellitus, Microalbuminuria
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Ramipril; Imidapril
• Other Study ID Numbers: UNIPV001DIM2010; 2010-023332-17 (EudraCT Number)