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

Novartis1 site in 1 country412 target enrollmentJanuary 2002

ConditionsHypertension Hypercholesterolemia Dyslipidemia

DrugsValsartan and simvastatin

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hypertension
Sponsor: Novartis
Enrollment: 412
Locations: 1
Primary Endpoint: Change from baseline in ambulatory systolic blood pressure at 12 weeks
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2002

End Date

April 2003

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Change from baseline in ambulatory systolic blood pressure at 12 weeks

Secondary Outcomes

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