How Does One Define Dose-Duration of an Antihypertensive Drug? What is the Role of Non-Mem and the Peak/Through Measurement?

Abstract

For a new drug to gain approval for the therapy of hypertension it is necessary but perhaps not sufficient that there be two or more adequately controlled trials that demonstrate an antihypertensive effect in a general population of patients with essential hypertension, and that the dosing interval for the antihypertensive effect be clear. The antihypertensive effect is taken simply as a reflection of a change in blood pressure in comparison to placebo. One could do a positive controlled trial which would be harder to do as a study because you have to be sure of the correct dose. Alternate possibilities to consider are baseline control with reversal or randomized withdrawal with placebo.