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...
Date First Received: September 12, 2005
Last Updated: March 20, 2008
Verified by: Novartis, March 2008
Clinical Trial Phase: Phase 4 | Start Date: July 2004
Overall Status: Completed
Estimated Enrollment: 100
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”
Condition Keyword(s):
Intervention(s):
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: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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 Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Principal Investigator Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
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
Clinical Trials Authorship and Review
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