Clinical trial NCT00417170 (phase 2, status: completed)
Conditions: high blood pressure, metabolic syndrome, insulin resistance, endothelial dysfunction
ICD codes: E88.81, Z16.11, Z16.21, D68.51, Z16.20, Z16.24, Z16.22, Z16.23, H18.513, H18.511, H18.512, H18.519
Drugs: aliskiren, amlodipine, placebo aliskiren, placebo amlodipine
SMILES: CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C, COC(=O)C1=C(C)NC(C)=C(C1C1=CC(=CC=C1)[N+]([O-])=O)C(=O)OC(C)(C)CN(C)CCC(C1=CC=CC=C1)C1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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:

               -  IFG: Fasting plasma glucose of 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9 mmol/l)

               -  IGT: Two-hour plasma glucose of 140 mg/dl (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l)

          -  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:

          -  Smokers (use of tobacco products in the recent past)

          -  Cardiovascular abnormalities including myocardial infarction, angina pectoris,
             hypertensive encephalopathy, stroke, transient ischemic attack, valvular heart
             disease, ventricular arrhythmia, A-V block, atrial fibrillation or cardiac
             revascularization/angioplasty in the past 12 months.

          -  Symptoms or clinical evidence of congestive heart failure or known left ventricular
             ejection fraction < 40%.

          -  Supine Blood pressure ≥ 160 mmHg systolic or ≥110 mmHg diastolic.

          -  Clinically significant echocardiogram (ECG) abnormalities, including history of a
             prolonged QT-interval syndrome.

          -  Significant autonomic dysfunction.

          -  Severe bronchospastic disease (including asthma and chronic obstructive pulmonary
             disease, treated or not treated).

          -  Clinically significant drug allergy, atopic allergy (asthma, urticaria, eczematous
             dermatitis).

          -  Pregnant or breastfeeding females. Pre-menopausal females who are not practicing a
             non-hormonal method of birth control.

          -  African Americans will not be eligible for this study.

        Other protocol-defined inclusion/exclusion criteria may apply.