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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00385931 |
Purpose
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 |
|---|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New Jersey | |
| Novartis Pharmaceuticals | |
| East Hanover, New Jersey, United States, 07936 | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Study ID Numbers: | CVAS489A2301 |
| Study First Received: | October 9, 2006 |
| Last Updated: | October 9, 2006 |
| ClinicalTrials.gov Identifier: | NCT00385931 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency |
|
Hypertension high cholesterol valsartan simvastatin |
|
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Simvastatin Antilipemic Agents Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Anticholesteremic Agents |
Antihypertensive Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Cardiovascular Diseases Hypercholesterolemia Dyslipidemias Valsartan Hypertension Lipid Metabolism Disorders |