Status:
COMPLETED
Effect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
Lead Sponsor:
Novartis
Conditions:
Hypertension
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00394745
Start Date
November 1 2005
End Date
June 1 2007
Last Update
February 24 2017
Active Locations (2)
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1
Investigative Centers, Germany
2
Novartis
Basel, Switzerland