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

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Metabolic Syndrome

Intervention: Valsartan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis + 41 61 324 1111 Basel, Study Director, Affiliation: Novartis Basel+ 41 61 324 1111

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Investigative Centers, Germany

Novartis, Basel, Switzerland

Additional Information

Starting date: November 2005
Last updated: November 7, 2011

Page last updated: August 20, 2015

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