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

Novartis

Status and phase

Completed

Phase 3

Conditions

Hypertension

Hypercholesterolemia

Dyslipidemia

Treatments

Drug: Valsartan and simvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00385931

CVAS489A2301

Details and patient eligibility

About

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.

Enrollment

412 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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)