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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171327
• Other study ID #: CXUO320BRU01
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: November 7, 2011
• Start date: July 2004
• Est. completion date: September 2005

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension

Intervention

Drug:
• valsartan, fluvastatin

Locations

Country	Name	City	State
Russian Federation	Novartis	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in brachial artery flow-mediated vasodilation after 8 weeks
Primary	Percent change from baseline in brachial artery flow-mediated vasodilation after 16 weeks compared to 8 weeks
Secondary	Percent change from baseline in low density lipoprotein cholesterol, total cholesterol, and triglycerides
Secondary	Evaluating blood pressure effect on endothelial function
Secondary	Evaluating total cholesterol effect on endothelial function