Effect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
Phase 3
Completed
- Conditions
- HypertensionMetabolic Syndrome
- Registration Number
- NCT00394745
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the effect of valsartan 320 mg on small, dense low density lipoprotein (LDL) subfractions in hypertensive patients with metabolic syndrome.
- Secondary Outcome Measures
Name Time Method To evaluate the effect of valsartan 320 mg on further lipid subfractions and enzymes related to the lipoprotein metabolism. To assess the safety and tolerability of valsartan 160-320mg. To evaluate the effect of valsartan 160-320 mg on blood pressure and pulse rate.
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland