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

Phase 3

Completed

• Conditions: Dyslipidemia; Hypertension; Hypercholesterolemia

• Registration Number: NCT00385931
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Study First Submitted: 2006-10-09
• Study First Submitted QC: 2006-10-09
• Study First Posted: 2006-10-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in ambulatory systolic blood pressure at 12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States