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

NCT01230034 | Unknown Phase 3 DMC

• 2 other identifiers: UNIPV001DIM20102010-023332-17
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Type 2 Diabetes Mellitus; Microalbuminuria

Keywords

Imidapril, Ramipril, Hypertension, Type 2 diabetes mellitus, Microalbuminuria

Outcome Measures

Primary Outcomes (1)

• Size of the reduction of urinary albumin in 24 hours to the various controls

  After 12 weeks from the beginning

Secondary Outcomes (1)

• 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

Study Arms (2)

Imidapril

EXPERIMENTAL

10 and 20 mg/day, pill

Drug: Imidapril

Ramipril

ACTIVE COMPARATOR

5 and 10 mg/day, pill

Drug: Ramipril

Interventions

Ramipril DRUG

pill, 5 and 10 mg/day, od, 24 weeks

Ramipril

Imidapril DRUG

pill, 10 and 20 mg/day, od, 24 weeks

Imidapril

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

University of Pavia

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Interventions

Ramipril; imidapril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Roberto Fogari, MD

  University of Pavia

  STUDY DIRECTOR

Central Study Contacts

Roberto Fogari, MD

CONTACT

+39 0382 526217; r.fogari@unipv.it

Giuseppe Derosa, MD

CONTACT

+39 0382 502614; giuseppe.derosa@unipv.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: October 28, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 28, 2010

Record last verified: 2010-10

Locations

IT (1)