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

NCT ID: NCT00385931

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 412 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2003-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Valsartan and simvastatin

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

CVAS489A2301

Identifier Type: -

Identifier Source: org_study_id