Effect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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: July 6, 2007
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