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Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin
This study has been completed.
First Received: October 9, 2006   No Changes Posted
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in ambulatory systolic blood pressure at 12 weeks

Secondary Outcome Measures:
  • Change from baseline at 12 weeks for ambulatory diastolic blood pressure, systolic and diastolic blood pressure (std cuff), day and nighttime blood pressures, biochemical markers of endothelial function & lipid levels
  • 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
Criteria

Inclusion Criteria:

  • Male or female patients at least 50 years of age
  • Mild to moderate essential systolic hypertension (grades 1 and 2 WHO classification) defined as MSSBP ≥ 150 mmHg and <180mmHg
  • Simultaneous primary hypercholesterolemia or mixed dislipidemia (Fredrickson Types IIa and IIb) defined by LDL-C level ≥ 130 mg/dL and <190 mg/dL and triglyceride levels ≤ 400 mg/dL despite dietary therapy
  • Off medication at randomization

Exclusion Criteria:

  • Severe hypertension (grade 3 WHO classification
  • ≥ 180 mm Hg systolic or ≥ 110 mm Hg (diastolic)
  • secondary form of hypertension
  • known Keith-Wagener Grade III or IV hypertensive retinopathy
  • history of hypertensive encephalopathy or cerebrovascular accident within the preceding 12 months
  • transient ischemic cerebral attack during the preceding 6 months
  • dyslipidemia secondary to other causes
  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus with poor glucose control
  • history of systemic inflammatory diseases
  • serum CK more than twice ULN
  • sodium depletion
  • malignancy in preceding 5 years history of heart failure
  • myocardial infarction within the preceding 12 months
  • second or third degree heart block
  • concomitant refractory angina pectoris
  • symptomatic arrhythmia
  • valvular heart disease
  • Any condition/surgery that may alter absorption, distribution, metabolism, excretion of any drug (e.g. history of major gastrointestinal tract surgery, inflammatory bowel syndrome, pancreatic dysfunction, impaired renal or liver function)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385931

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

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

Keywords provided by Novartis:
Hypertension
high cholesterol
valsartan
simvastatin

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010