Diabetes, Hypertension
Conditions
Keywords
Hypertension,, diabetes,, aliskiren,, blood pressure,, valsartan,, hydrochlorothiazide
Brief summary
To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide
Interventions
DRUGaliskiren
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with essential hypertension * Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus. * Patients who are eligible and able to participate in the study
Exclusion criteria
* Severe hypertension * Uncontrolled diabetes type I and II * History or evidence of a secondary form of hypertension * History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in diastolic blood pressure after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in systolic blood pressure after 12 weeks | — |
| Change from baseline in systolic and diastolic blood pressure after 6 weeks | — |
| Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks | — |
| Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks | — |
Countries
Belgium, Romania, Spain, Sweden, Switzerland, Ukraine, United States
Outcome results
None listed