Diabetes Mellitus Type 2, Hypertension
Conditions
Keywords
Microalbuminaria in hypertensive patients with type II diabetes mellitus
Brief summary
To show that Irbesartan improves endothelial dysfunction and the procoagulant state which are thought to be the possible mechanisms, inducing a generalized vasculopathy associated with microalbuminuria and vascular events in type II diabetic hypertensive patients
Interventions
DRUGIrbesartan
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* non insulin dependent type II manifest diabetes with glycosilated HbA1c levels over %6.5-8 * mild to moderate hypertension stage I and stage II according to ESC-ESH 2003 (140-180 mmHg)
Exclusion criteria
* congestive heart failure * azotemia * insulin dependent diabetes * liver insufficiency * pregnancy * cancer The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the effect of irbesartan on nitric oxide (NO), which has key role in the endothelial dysfunction and the development of pressure vasomotor response, compared to standard therapy (atenolol) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the effect of irbesartan on chronic inflammatory process and tendency for procoagulation, associated with endothelial dysfunction, compared to atenolol. | — |
Countries
Turkey (Türkiye)
Outcome results
None listed