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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00385931 |
This study will assess and compare the efficacy and safety of valsartan and the combination of valsartan and simvastatin in patients with high blood pressure and high cholesterol.
Condition | Intervention | Phase |
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Hypertension Hypercholesterolemia Dyslipidemia |
Drug: Valsartan and simvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Centre Study to Evaluate the Effects of Valsartan and the Combination of Valsartan and Simvastatin on Blood Pressure (Ambulatory and Std Cuff) and on Biochemical Markers of Endothelial Function (hsCRP, MCP-1, Serum F2 Isoprostanes, PAI-1, tPA, PICP, PIIINP, MMP9, MMP1, TIMP 1), Safety and Tolerability |
Estimated Enrollment: | 354 |
Study Start Date: | January 2002 |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Novartis Pharmaceuticals | |
East Hanover, New Jersey, United States, 07936 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Study ID Numbers: | CVAS489A2301 |
Study First Received: | October 9, 2006 |
Last Updated: | October 9, 2006 |
ClinicalTrials.gov Identifier: | NCT00385931 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency |
Hypertension high cholesterol valsartan simvastatin |
Metabolic Diseases Hyperlipidemias Simvastatin Plasminogen Activator Inhibitor 1 Vascular Diseases Metabolic disorder |
Hypercholesterolemia Valsartan Dyslipidemias Lipid Metabolism Disorders Hypertension |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors Cardiovascular Diseases |
Cardiovascular Agents Anticholesteremic Agents Antihypertensive Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |