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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00394745

Enrollment

Registered

2006-11-01

Start date

2005-11-30

Completion date

2007-06-30

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Metabolic Syndrome

Keywords

Hypertension, Metabolic Syndrome, lipid subfractions

Brief 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.

Interventions

DRUGValsartan

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026