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Efficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction

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ClinicalTrials.gov Identifier: NCT00171327
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
Patients with mild to moderate hypertension, dyslipidemia (imbalanced blood lipids) and decreased vascular dilatation, receiving a cholesterol lowering diet were given either valsartan or fluvastatin for 8 weeks. At week 8 all patients were administered a combination treatment with valsartan 160 mg and fluvastatin 80 mg.

Condition or disease Intervention/treatment Phase
Hypertension Dyslipidemia Drug: valsartan, fluvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fluvastatin 80 mg or Valsartan 160 mg and Their Combination in Dyslipidemic Patients With Arterial Hypertension and Endothelial Dysfunction
Study Start Date : July 2004
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Percent change from baseline in brachial artery flow-mediated vasodilation after 8 weeks
  2. Percent change from baseline in brachial artery flow-mediated vasodilation after 16 weeks compared to 8 weeks

Secondary Outcome Measures :
  1. Percent change from baseline in low density lipoprotein cholesterol, total cholesterol, and triglycerides
  2. Evaluating blood pressure effect on endothelial function
  3. Evaluating total cholesterol effect on endothelial function


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Arterial hypertension
  • Dyslipidemia
  • Cholesterol lowering diet

Exclusion Criteria:

  • Constant antihypertensive treatment
  • Diabetes mellitus
  • Myocardial infarction or stroke in the previous 3 months

Other inclusion and exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171327


Locations
Russian Federation
Novartis
Moscow, Russian Federation
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171327     History of Changes
Other Study ID Numbers: CXUO320BRU01
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Novartis:
arterial hypertension
dyslipidemia
valsartan
fluvastatin

Additional relevant MeSH terms:
Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Valsartan
Fluvastatin
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors