Effects of Blood Pressure Reduction on High Sensitivity C-Reactive Protein (hsCRP)

Study Overview
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Brief Summary
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The study compares the efficacy of an aggressive versus a moderate initial antihypertensive regimen to reduce blood pressure in patients with Stage 2 hypertension. Additionally, the study examines the effects of blood pressure reduction on the levels of high sensitivity hsCRP. Although the main goal is to determine the overall effect of blood pressure reduction on hsCRP levels, analysis will also evaluate whether an aggressive antihypertensive regimen is more effective than a moderate one in reducing hsCRP levels.

Official Title
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Effects of Blood Pressure Reduction on High Sensitivity C-Reactive Protein (hsCRP)

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Valsartan, Valsartan HCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage 2 hypertension as defined by the mean of three (3) repeated seated BP measurements of: SBP of 160 to 185 mmHg, inclusive and/or DBP of 100 to 109 mmHg, inclusive. Patients must have documentation of serum creatinine equal or <2.0 mg/dL, serum potassium equal or >3.5 and equal or <5.5 mmol/L, and serum AST or ALT <2xULN obtained within 3 months prior to Visit 1. Patients must have documentation of HbA1C equal or <11.0 % obtained within 1 month prior to Visit 1. Exclusion Criteria: History of secondary hypertension. Pharmacologic antihypertensive therapy with ACE inhibitors, angiotensin receptor blockers, or aldosterone blockers within 3 months prior to Visit 1, or with thiazide diuretics within 1 month prior to Visit 1. The use of other classes of agents which lower BP but are being used for other therapy or for HTN, are allowed as long as these agents are started at least 3 months prior to randomization, are not initiated after enrollment and doses remain unchanged during the study. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valsartan, Valsartan HCT|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 6 in mean sitting blood pressure (SD) |  |  | 
| Change from baseline to Week 12 in median plasma hsCRP |  |  | 
| Change from baseline to Week 6 in median plasma hsCRP |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of responders with change in systolic BP |  |  | 
| Time to first SBP reduction |  |  | 
| Proportion of subjects achieving SBP control |  |  | 
| Change in mean sitting DBP |  |  | 
| Change in hsCRP for subjects with baseline hsCRP greater or equal to 3.0 mg/L |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension (HTN), High Sensitivity C-Reactive Protein