Hypertension, Type 2 Diabetes
Conditions
Keywords
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)
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
Interventions
DRUGRamipril
tablet; 10 mg; od; 3 months
DRUGExperimental
tablet; 300 mg; od; 3 months
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Italy
Contacts
Primary ContactRoberto Fogari, MD
Outcome results
None listed