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

This study has been completed.

First Received: October 31, 2006 Last Updated: July 6, 2007 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00394745

Purpose

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.

Condition	Intervention	Phase
Hypertension Metabolic Syndrome	Drug: Valsartan	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Lipids Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	50
Study Start Date:	November 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394745

Locations

Germany

Investigative Centers, Germany
Switzerland
Novartis
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis + 41 61 324 1111 Basel

Novartis Basel+ 41 61 324 1111

More Information

No publications provided

Study ID Numbers:	CVAL489ADE25
Study First Received:	October 31, 2006
Last Updated:	July 6, 2007
ClinicalTrials.gov Identifier:	NCT00394745 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Hypertension, Metabolic Syndrome, lipid subfractions

Additional relevant MeSH terms:

Pathologic Processes
Disease
Therapeutic Uses
Syndrome
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010