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

NCT ID: NCT00417170

Last Updated: 2011-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-07-31

Brief Summary

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.

Conditions

High Blood Pressure; Metabolic Syndrome; Insulin Resistance; Endothelial Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Aliskiren 300 mg

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.

Group Type: EXPERIMENTAL

Aliskiren

Intervention Type: DRUG

Aliskiren 300 mg tablets taken orally once daily

Placebo Amlodipine

Intervention Type: DRUG

Placebo Amlodipine taken orally once daily

Amlodipine 5 mg

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.

Group Type: ACTIVE_COMPARATOR

Amlodipine

Intervention Type: DRUG

Amlodipine 5 mg capsule taken orally once daily

Placebo Aliskiren

Intervention Type: DRUG

Placebo Aliskiren taken orally once daily.

Interventions

Aliskiren

Aliskiren 300 mg tablets taken orally once daily

Intervention Type: DRUG

Amlodipine

Amlodipine 5 mg capsule taken orally once daily

Intervention Type: DRUG

Placebo Aliskiren

Placebo Aliskiren taken orally once daily.

Intervention Type: DRUG

Placebo Amlodipine

Placebo Amlodipine taken orally once daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Santa Monica, California, United States

Countries

United States

Other Identifiers

CSPP100A2239

Identifier Type: -

Identifier Source: org_study_id