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

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Simvastatin; Valsartan

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)