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Completed

NCT Number: NCT00394745

Effect of Valsartan 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Centers, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valsartan

Drug

Primary outcomes

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

Secondary outcomes

  1. To evaluate the effect of valsartan 320 mg on further lipid subfractions and enzymes related to the lipoprotein metabolism.

  2. To evaluate the effect of valsartan 160-320 mg on blood pressure and pulse rate.

  3. To assess the safety and tolerability of valsartan 160-320mg.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 1, 2006
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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