Hypertension
Conditions
Keywords
Hypertension (HTN), High Sensitivity C-Reactive Protein
Brief summary
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.
Interventions
DRUGValsartan, Valsartan HCT
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
1. 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. 2. 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. 3. Patients must have documentation of HbA1C equal or \<11.0 % obtained within 1 month prior to Visit 1.
Exclusion criteria
1. History of secondary hypertension. 2. 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/
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Change in mean sitting DBP | — |
| Proportion of responders with change in systolic BP | — |
| Change in hsCRP for subjects with baseline hsCRP greater or equal to 3.0 mg/L | — |
| Time to first SBP reduction | — |
| Proportion of subjects achieving SBP control | — |
Outcome results
None listed