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Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome

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Novartis

Status and phase

Completed
Phase 2

Conditions

High Blood Pressure
Endothelial Dysfunction
Insulin Resistance
Metabolic Syndrome

Treatments

Drug: Placebo Aliskiren
Drug: Aliskiren
Drug: Amlodipine
Drug: Placebo Amlodipine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00417170
CSPP100A2239

Details and patient eligibility

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

48 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

48 participants in 2 patient groups

Aliskiren 300 mg
Experimental group
Description:
Eligible participants received oral Aliskiren 300 mg + Placebo Amlodipine once daily for 12 weeks. Study medication was taken with 200 mL of water in the morning. Breakfast was eaten 1 hour after taking study medication. Study medication was swallowed whole, and not chewed.
Treatment:
Drug: Aliskiren
Drug: Placebo Amlodipine
Amlodipine 5 mg
Active Comparator group
Description:
Eligible participants received oral Amlodipine 5 mg + Placebo Aliskiren once daily for 12 weeks. Study medication was taken with 200 mL of water in the morning. Breakfast was eaten 1 hour after taking study medication. Study medication was swallowed whole, and not chewed.
Treatment:
Drug: Placebo Aliskiren
Drug: Amlodipine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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