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

Primary Purpose

Hypertension, Type 2 Diabetes Mellitus, Microalbuminuria

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ramipril
Imidapril
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Imidapril, Ramipril, Hypertension, Type 2 diabetes mellitus, Microalbuminuria

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of PaviaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Imidapril

Ramipril

Arm Description

10 and 20 mg/day, pill

5 and 10 mg/day, pill

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
October 27, 2010
Last Updated
October 27, 2010
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT01230034
Brief Title
Antiproteinuric Effect of Imidapril Versus Ramipril in Type 2 Diabetic and Hypertensive Patients With Microalbuminuria
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pavia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Type 2 Diabetes Mellitus, Microalbuminuria
Keywords
Imidapril, Ramipril, Hypertension, Type 2 diabetes mellitus, Microalbuminuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imidapril
Arm Type
Experimental
Arm Description
10 and 20 mg/day, pill
Arm Title
Ramipril
Arm Type
Active Comparator
Arm Description
5 and 10 mg/day, pill
Intervention Type
Drug
Intervention Name(s)
Ramipril
Intervention Description
pill, 5 and 10 mg/day, od, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Imidapril
Intervention Description
pill, 10 and 20 mg/day, od, 24 weeks
Primary Outcome Measure Information:
Title
Size of the reduction of urinary albumin in 24 hours to the various controls
Time Frame
After 12 weeks from the beginning
Secondary Outcome Measure Information:
Title
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.
Time Frame
After 12 weeks from the beginning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Fogari, MD
Phone
+39 0382 526217
Email
r.fogari@unipv.it
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Derosa, MD
Phone
+39 0382 502614
Email
giuseppe.derosa@unipv.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Fogari, MD
Organizational Affiliation
University of Pavia
Official's Role
Study Director
Facility Information:
Facility Name
University of Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Derosa, MD
Phone
+39 0382 526217
Email
giuseppe.derosa@unipv.it
First Name & Middle Initial & Last Name & Degree
Giuseppe Derosa, MD

12. IPD Sharing Statement

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

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