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

NCT ID: NCT01230034

Last Updated: 2010-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Type 2 Diabetes Mellitus Microalbuminuria

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imidapril

10 and 20 mg/day, pill

Group Type EXPERIMENTAL

Imidapril

Intervention Type DRUG

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

Ramipril

5 and 10 mg/day, pill

Group Type ACTIVE_COMPARATOR

Ramipril

Intervention Type DRUG

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

Interventions

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Ramipril

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

Intervention Type DRUG

Imidapril

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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University of Pavia

Principal Investigators

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Roberto Fogari, MD

Role: STUDY_DIRECTOR

University of Pavia

Locations

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University of Pavia

Pavia, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Roberto Fogari, MD

Role: CONTACT

Phone: +39 0382 526217

Email: [email protected]

Giuseppe Derosa, MD

Role: CONTACT

Phone: +39 0382 502614

Email: [email protected]

Facility Contacts

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Giuseppe Derosa, MD

Role: primary

Other Identifiers

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2010-023332-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UNIPV001DIM2010

Identifier Type: -

Identifier Source: org_study_id