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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension, Hypercholesterolemia, Dyslipidemia

Intervention / Treatment
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* Drug: Valsartan and simvastatin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valsartan and simvastatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in ambulatory systolic blood pressure at 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, high cholesterol, valsartan, simvastatin