Effect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
This study has been completed.
Information provided by (Responsible Party):
First received: October 31, 2006
Last updated: November 7, 2011
Last verified: November 2011
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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:
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.
|Study Start Date:||November 2005|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Contacts and Locations