Hypertension Clinical Trial
Official title:
Part 1: An Open Label Pilot Study to Determine Interstitial and Tissue Concentrations of Aliskiren and Effects on the Renin- Angiotensin System (RAS) in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity. Part 2: A Randomized, Double Blind, 12-weeks Parallel Group Study to Compare Effects of Aliskiren 300 mg and Amlodipine 5 mg on the RAS and Lipid/Carbohydrate Metabolism in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity
Part 1 determined: aliskiren, amlodipine and angiotensin II concentrations in interstitial
fluid of fat and skeletal muscle; aliskiren and angiotensin II concentrations, and renin
activity and concentration in fat and skeletal muscle tissues (biopsies); aliskiren,
amlodipine and angiotensin II concentrations, and renin activity and concentration in
plasma.
Part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone
system (RAAS) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle
tissue in obese patients with hypertension in comparison to amlodipine.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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