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

Phase 4

• Conditions: Hypertension; Type 2 Diabetes
• Interventions: Drug: Ramipril; Drug: Experimental

• Registration Number: NCT01038895
• Lead Sponsor: University of Pavia

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:

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

Not available

Study Timeline

• Status Verified: 2009-09
• Study Start: 2009-11
• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-23
• Last Update Submitted: 2009-12-23
• Study First Posted: 2009-12-24
• Last Update Posted: 2009-12-24
• Primary Completion: 2010-03
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ramipril	Ramipril	10 mg/daily
Aliskiren	Experimental	300 mg/ daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pavia; 🇮🇹 Pavia, PV, Italy