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Status:

COMPLETED

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

Lead Sponsor:

Novartis

Conditions:

Hypertension

Hypercholesterolemia

Eligibility:

All Genders

50+ years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

January 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2003

Estimated Enrollment :

412 Patients enrolled

Trial Details

Trial ID

NCT00385931

Start Date

January 1 2002

End Date

April 1 2003

Last Update

November 9 2023

Active Locations (1)

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States, 07936