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

A 12 Week Treatment, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Valsartan 160-320 mg With Regard to Effects on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Metabolic Syndrome
• Intervention / Treatment: Drug: Valsartan

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Investigative Centers, Germany
• Switzerland
  • Basel, Switzerland
    • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the effect of valsartan 320 mg on small, dense low density lipoprotein (LDL) subfractions in hypertensive patients with metabolic syndrome.

Secondary Outcome Measures

Outcome Measure
To evaluate the effect of valsartan 320 mg on further lipid subfractions and enzymes related to the lipoprotein metabolism.
To evaluate the effect of valsartan 160-320 mg on blood pressure and pulse rate.
To assess the safety and tolerability of valsartan 160-320mg.

Collaborators and Investigators

• Sponsor: Novartis
• Investigators: Study Director: Novartis + 41 61 324 1111 Basel, Novartis Basel+ 41 61 324 1111

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: October 31, 2006
• First Submitted That Met QC Criteria: October 31, 2006
• First Posted (Estimate): November 1, 2006

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Hypertension, Metabolic Syndrome, lipid subfractions
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Hypertension; Syndrome; Metabolic Syndrome; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan
• Other Study ID Numbers: CVAL489ADE25