Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin

Condition(s) targeted: Hypertension; Hypercholesterolemia; Dyslipidemia

Intervention: Valsartan and simvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in ambulatory systolic blood pressure at 12 weeks

Secondary outcome:

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

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

- serum CK more than twice ULN

- sodium depletion

- malignancy in preceding 5 years history of heart failure

- myocardial infarction within the preceding 12 months

- second or third degree heart block

- concomitant refractory angina pectoris

- symptomatic arrhythmia

- valvular heart disease

- Any condition/surgery that may alter absorption, distribution, metabolism, excretion

of any drug (e. g. history of major gastrointestinal tract surgery, inflammatory bowel syndrome, pancreatic dysfunction, impaired renal or liver function)

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Starting date: January 2002
Last updated: October 9, 2006