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About
The purpose of this study was to determine the effects of Aliskiren on insulin resistance (IR) and endothelial dysfunction (ED) in patients with high blood pressure and metabolic syndrome. The efficacy of Aliskiren was compared to Amlodipine.
Enrollment
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Inclusion criteria
Male or female adults aged 18 to 55 years, inclusive.
Sitting diastolic blood pressure ≥80 mm Hg and/or sitting systolic blood pressure ≥ 130 at screening.
Metabolic Syndrome as defined by the Adult Treatment Panel (ATP) III criteria.
Hypertension (defined above) and impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) plus one or more out of the remaining 3 criteria to satisfy entry into the study. IGT and IFG will be classified according to American Diabetes Association (ADA) guidelines:
Abnormal Positron Emission Tomography (PET) results at baseline. (Myocardial Blood Flow (MBF) of less than or equal to 35%.)
Abnormal euglycemic clamp results at baseline. (Glucose infusion rate (GINF) of less than or equal to 4.2 mg/kg/min.)
Body mass index (BMI) of less than 40.
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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