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

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ClinicalTrials.gov Identifier: NCT01230034
Recruitment Status : Unknown
Verified October 2010 by University of Pavia.
Recruitment status was:  Recruiting
First Posted : October 28, 2010
Last Update Posted : October 28, 2010
Sponsor:
Information provided by:
University of Pavia

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.

Condition or disease Intervention/treatment Phase
Hypertension Type 2 Diabetes Mellitus Microalbuminuria Drug: Ramipril Drug: Imidapril Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril

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




Primary Outcome Measures :
  1. Size of the reduction of urinary albumin in 24 hours to the various controls [ Time Frame: After 12 weeks from the beginning ]

Secondary Outcome Measures :
  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. [ Time Frame: After 12 weeks from the beginning ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230034


Contacts
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Contact: Roberto Fogari, MD +39 0382 526217 r.fogari@unipv.it
Contact: Giuseppe Derosa, MD +39 0382 502614 giuseppe.derosa@unipv.it

Locations
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Italy
University of Pavia Recruiting
Pavia, Italy, 27100
Contact: Giuseppe Derosa, MD    +39 0382 526217    giuseppe.derosa@unipv.it   
Sub-Investigator: Giuseppe Derosa, MD         
Sponsors and Collaborators
University of Pavia
Investigators
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Study Director: Roberto Fogari, MD University of Pavia
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Responsible Party: Prof. GianMario Frigo, University of Pavia
ClinicalTrials.gov Identifier: NCT01230034    
Other Study ID Numbers: UNIPV001DIM2010
2010-023332-17 ( EudraCT Number )
First Posted: October 28, 2010    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: October 2010
Keywords provided by University of Pavia:
Imidapril, Ramipril, Hypertension, Type 2 diabetes mellitus, Microalbuminuria
Additional relevant MeSH terms:
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Hypertension
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Ramipril
Imidapril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents