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NCT00394745 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00394745
Other study ID # CVAL489ADE25
Secondary ID
Status Completed
Phase Phase 3
First received October 31, 2006
Last updated February 22, 2017
Start date November 2005
Est. completion date June 2007

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Valsartan

Locations
Country Name City State
Switzerland Novartis Basel

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the effect of valsartan 320 mg on small, dense low density lipoprotein (LDL) subfractions in hypertensive patients with metabolic syndrome.
Secondary To evaluate the effect of valsartan 320 mg on further lipid subfractions and enzymes related to the lipoprotein metabolism.
Secondary To evaluate the effect of valsartan 160-320 mg on blood pressure and pulse rate.
Secondary To assess the safety and tolerability of valsartan 160-320mg.
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