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

Study Overview
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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: 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

Conditions
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Hypertension, Type 2 Diabetes

Intervention / Treatment
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* Drug: Ramipril
* Drug: Experimental


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ramipril<br>10 mg/daily | Drug: Ramipril<br>* tablet; 10 mg; od; 3 months<br>|
| Experimental: Aliskiren<br>300 mg/ daily | Drug: Experimental<br>* tablet; 300 mg; od; 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)