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

Sponsor

University of Pavia (Other)

Overall Status

Unknown status

CT.gov ID

NCT01038895

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks at various visits
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

Condition or Disease	Intervention/Treatment	Phase
Hypertension Type 2 Diabetes	Drug: Ramipril Drug: Experimental	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Nov 1, 2009

Anticipated Primary Completion Date :

Mar 1, 2010

Anticipated Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ramipril 10 mg/daily	Drug: Ramipril tablet; 10 mg; od; 3 months
Experimental: Aliskiren 300 mg/ daily	Drug: Experimental tablet; 300 mg; od; 3 months

Arm

Intervention/Treatment

Active Comparator: Ramipril

10 mg/daily

Drug: Ramipril

tablet; 10 mg; od; 3 months

Experimental: Aliskiren

300 mg/ daily

Drug: Experimental

tablet; 300 mg; od; 3 months

Outcome Measures

Primary Outcome Measures

Antiproteinuric effect as well as antihypertensive effect of aliskiren 300 mg / daily versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria. [3 months]

Secondary Outcome Measures

Average of 24 hours by ABPM, systolic and diastolic blood pressure [3 months]
Average daytime, systolic and diastolic blood pressure [3 months]
Average night, systolic and diastolic blood pressure [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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