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Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria

NCT ID: NCT01038895

Last Updated: 2009-12-24

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

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-06-30

Brief Summary

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The main objective of this study is to assess the extent and trend in time of antiproteinuric effect as well as that antihypertensive effect of aliskiren 300 mg / d versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria. The investigators will also evaluate:

1. Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks at various visits
2. Average daytime, as determined by ABPM, systolic and diastolic blood pressure checks at various visits 3. Average night, as determined by ABPM, systolic and diastolic blood pressure checks at various visits

Detailed Description

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Conditions

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Hypertension Type 2 Diabetes

Keywords

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Hypertension type 2 diabetes aliskiren ramipril microalbuminuria blood pressure> 130/80 <180/105 mmHg at the end of the wash-out type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c <7%) Microalbuminuria in the upper range of normal (> 200 <300 mg/24 h)

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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Ramipril

10 mg/daily

Group Type ACTIVE_COMPARATOR

Ramipril

Intervention Type DRUG

tablet; 10 mg; od; 3 months

Aliskiren

300 mg/ daily

Group Type EXPERIMENTAL

Experimental

Intervention Type DRUG

tablet; 300 mg; od; 3 months

Interventions

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Ramipril

tablet; 10 mg; od; 3 months

Intervention Type DRUG

Experimental

tablet; 300 mg; od; 3 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* blood pressure \> 130/80 \<180/105 mmHg at the end of the wash-out
* type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c \<7%)
* microalbuminuria in the upper range of normal (\> 200 \<300 mg/24 h)

Exclusion Criteria

* Pregnancy, lactation or women of childbearing age
* Sitting diastolic blood pressure e 105 mmHg or systolic pressure e 180 at the end of the period of wash-out
* History of hypertensive encephalopathy or cerebrovascular accident within 6 months
* Secondary hypertension
* Heart Failure
* Myocardial infarction within 6 months
* Angina pectoris, clinically significant valvular disease or arrhythmia
* Alteration indices of liver function or renal
* Known hypersensitivity to ACE inhibitors
* All other physiological or pathological condition in the opinion of the physician may affect the evaluation of the parameters under study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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, PV, 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]

Facility Contacts

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Amedeo Mugellini, MD

Role: primary

Other Identifiers

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2009-016481-83

Identifier Type: REGISTRY

Identifier Source: secondary_id

UNIPV002DIM2009

Identifier Type: -

Identifier Source: org_study_id