Hypertension Clinical Trial
Official title:
A 16-weeks, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Anti-inflammatory Actions of 320 mg Diovan in Patients With Type 2 Diabetes With and Without Coronary Artery Disease
This study is designed to support the use of valsartan in the diabetic population. Two
different groups will be studied, one with and one without coronary artery disease (CAD)
documented by angiography.
The study is intended to demonstrate that valsartan 320 mg has an anti-inflammatory
potential, reducing inflammatory serum markers as well as inflammatory gene expression, and
to show that valsartan is able to improve metabolic parameters in this patient population.
Furthermore, in the subgroup of patients with documented CAD this study wants to show that
valsartan improves coronary perfusion.
3 Objectives
Primary objectives:
1. To demonstrate the anti-inflammatory efficacy of valsartan 160/320 mg by testing the
hypothesis of superiority compared to placebo in the reduction of the inflammatory
marker Tumor necrosis factor alpha (TNFα) in plasma after 16 weeks of treatment in
hypertensive patients with type 2 diabetes mellitus.
2. To demonstrate the anti-inflammatory efficacy of valsartan 160/320 mg by testing the
hypothesis of superiority compared to placebo in the reduction of the inflammatory
marker Interleukin 6 (IL-6) in plasma after 16 weeks of treatment in hypertensive
patients with type 2 diabetes mellitus.
Secondary objectives:
1. To explore the effect of 160/320 mg valsartan on parameters of insulin sensitivity.
2. To explore the effect of 160/320 mg valsartan on additional inflammatory markers in
plasma [e.g. C-Reactive protein (CRP), soluble intracellular adhesion molecule-1
(sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), serum amyloid A (SAA),
soluble CD40 ligand (sCD40L), fibrinogen, Interleukin 1β (IL-1β), matrix
metalloproteases -2, -3 and -9 (MMP-2, -3, -9), and sE-selectin)].
3. To explore the effect of 160/320 mg valsartan on inflammatory gene expression from
monocytes and fat tissue.
4. To explore the effect of 160/320 mg valsartan on metabolic gene expression in fat
tissue.
5. To explore the effect of 160/320 mg valsartan on coronary perfusion, in the group of
patients with angiographically documented CAD.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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