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

University of Pavia

Status and phase: Unknown; Phase 4

Conditions: Hypertension; Type 2 Diabetes

Treatments: Drug: Experimental; Drug: Ramipril

Study type: Interventional

Funder types: Other

Identifiers

NCT01038895

2009-016481-83 (Registry Identifier)

UNIPV002DIM2009

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Ramipril

Active Comparator group

Description:

10 mg/daily

Treatment:

Drug: Ramipril

Aliskiren

Experimental group

Description:

300 mg/ daily

Treatment:

Drug: Experimental