Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension

Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period

Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentrations on the last day of the aliskiren treatment periods (Day 42).

Time frame: Day 42

Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period

Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentration on the last day of the amlodipine treatment periods (Day 98).

Time frame: Day 98

Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period

Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.

Time frame: Day 42

Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period

Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.

Time frame: Day 98

Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period

Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine aliskiren concentration. Tissue biopsy samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).

Time frame: Day 42

Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period

Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine Ang II concentration.

Time frame: Day 42

Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period

Time frame: Day 42

Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period

Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42).

Time frame: Day 42

Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period

Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the amlodipine treatment periods (Day 98).

Time frame: Day 98

Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period

Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.

Time frame: Day 42

Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period

Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.

Time frame: Day 98

Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period

Renin concentrations from plasma were measured as: plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).

Time frame: Day 42

Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period

Renin concentrations from plasma were measured as plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).

Time frame: Day 98

Part 1: Renin Activity From Plasma During Aliskiren Treatment Period

Plasma Renin activity (PRC) was measured by a trapping PRA (tPRA) assay.

Time frame: Day 42

Part 1: Renin Activity From Plasma During Amlodipine Treatment Period

Plasma renin activity (PRC) was measured by a trapping PRA (tPRA) assay.

Time frame: Day 98

Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period

Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.

Time frame: Placebo Baseline (Day 14), Active Treatment (Day 98)

Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period

Plasma Ang II was measured prior to and 1 hour after the Insulin modified-frequently sampled intravenous glucose tolerance test (IM-FSIGT) during placebo treatment (Days 14) and active treatment(Day 98).

Time frame: Placebo Baseline (Day 14), Active Treatment (Day 98)

Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period

Time frame: Day 98

Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period

Time frame: Day 98