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

Hypertension Clinical Trial

Official title:

A Multi-centre Study to Evaluate the Effects of Valsartan and the Combination of Valsartan and Simvastatin on Blood Pressure (Ambulatory and Std Cuff) and on Biochemical Markers of Endothelial Function (hsCRP, MCP-1, Serum F2 Isoprostanes, PAI-1, tPA, PICP, PIIINP, MMP9, MMP1, TIMP 1), Safety and Tolerability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385931
• Other study ID #: CVAS489A2301
• Status: Completed
• Phase: Phase 3
• Start date: January 2002
• Est. completion date: April 2003

Study information

• Verified date: November 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia
• Hypertension

Intervention

Drug:
• Valsartan and simvastatin

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in ambulatory systolic blood pressure at 12 weeks
Secondary	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
Secondary	Safety and tolerability