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

NCT00385931 | Completed Phase 3

• 1 other identifier: CVAS489A2301
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Hypercholesterolemia; Dyslipidemia

Keywords

Hypertension; high cholesterol; valsartan; simvastatin

Outcome Measures

Primary Outcomes (1)

• Change from baseline in ambulatory systolic blood pressure at 12 weeks

Secondary Outcomes (2)

• 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

Interventions

Valsartan and simvastatin DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Hypertension; Hypercholesterolemia; Dyslipidemias

Interventions

Valsartan; Simvastatin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2006
• First Posted: October 11, 2006
• Study Start: January 1, 2002
• Primary Completion: April 1, 2003
• Study Completion: April 1, 2003
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

US (1)