Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension
Condition: Hypertension; Abdominal Obesity
MeSH terms: Hypertension; Obesity; Obesity, Abdominal
Intervention: Aliskiren; Amlodipine; Placebo of Aliskiren; Placebo of amlodipine
Intervention description: 300 mg tablet once daily; 5 mg capsule once daily; Matching placebo of aliskiren 300 mg tablet; Matching placebo of amlodipine 5 mg capsule
Intervention MeSH terms: Amlodipine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Aliskiren; Renin-Angiotensin System (RAS); Hypertension; Abdominal obesity

Summary:

      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.
    

Eligibility criteria:

        Inclusion criteria:

        PART 1:

          -  Male and female patients 20 to 65 years of age with a diagnosis of hypertension and
             with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)

          -  For patients with a history of treated hypertension, mean sitting systolic blood
             pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) had to be ≥ 120/80
             mmHg and ≤ 160/100 mm Hg. For patients with newly diagnosed, untreated hypertension
             msSBP/msDBP had to be ≥ 135/85 mmHg and ≤ 160/100 mm Hg

          -  Pulse rate 40 - 90 bpm

        PART 2:

          -  Male and female patients 18 to 65 years of age , with a diagnosis of hypertension and
             with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)

          -  Systolic and diastolic blood pressure and pulse rate were assessed after the patient
             had rested for at least five (5) minutes. Vital signs had to be within the following
             ranges:

               1. Patients with history of treated hypertension: msSBP/msDBP ≥ 135/85 mmHg and <
                  160/100 mmHg at baseline

               2. Patients with newly diagnosed, untreated hypertension: msSBP/msDBP ≥ 135/85 mmHg
                  and < 160/100 mmHg at screening and baseline.

        Exclusion criteria:

        PART 1

          -  Hypertension Grade 2 (msSBP ≥ 160 mmHg) or Grade 3 (msDBP ≥ 110 mmHg and/or msSBP ≥
             180 mmHg) WHO classification

          -  Current treatment with three or more antihypertensive drugs.

        PART 2

          -  Hypertension Grade 2 (msSBP ≥ 160 and/or msDBP ≥ 100 mmHg).

          -  Current treatment with three or more antihypertensive drugs.

        Other protocol-defined inclusion/exclusion criteria applied