Efficacy and Safety of Fluvastatin or Valsartan and Their Combination in Dyslipidemic Patients With Hypertension and Endothelial Dysfunction
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: September 2005
Intervention(s) in this Clinical Trial
- Drug: valsartan, fluvastatin
Outcome Measures for this Clinical Trial
Primary Measures
- Percent change from baseline in brachial artery flow-mediated vasodilation after 8 weeks
- Percent change from baseline in brachial artery flow-mediated vasodilation after 16 weeks compared to 8 weeks
Secondary Measures
- Percent change from baseline in low density lipoprotein cholesterol, total cholesterol, and triglycerides
- Evaluating blood pressure effect on endothelial function
- Evaluating total cholesterol effect on endothelial function
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Principal Investigator Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00171327
Study ID Number: CXUO320BRU01
ClinicalTrials.gov Identifier: NCT00171327
Health Authority: Russia: Pharmacological Committee, Ministry of Health
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00171327
