Effect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension; Metabolic Syndrome

Treatments: Drug: Valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394745

CVAL489ADE25

Details and patient eligibility

About

The purpose of this study is to evaluate potential effects of valsartan on lipid subfractions and other parameters in lipid metabolism in patients with essential hypertension and metabolic syndrome.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female outpatients >= 18 years of age at Visit 1
• Hypertension (systolic blood pressure >= 140 mmHg and < 170 mmHg and/or diastolic blood pressure >= 90 mmHg and < 105 mmHg
• Elevated triglycerides
• Metabolic syndrome as defined by Adult Treatment Panel III criteria

Exclusion criteria

• MSSBP >= 170 mmHg and/or MSDBP >= 105 mmHg at any time between Visit 1 and Visit 2
• Diabetes mellitus
• Patients treated with lipid lowering drugs in the last 6 weeks prior to Visit 1
• A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease, heart failure NYHA II - IV Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)