Anglo-Swedish drug major AstraZeneca has received European approval for two new dose strengths of its the angiotensin receptor blocker Atacand Plus (candesartan cilexetil 32mg, with HCT 12.5mg or 25mg), for the treatment of hypertension when the disease is not optimally controlled by monotherapy alone.
The trials supporting the new dose strengths included a study with an eight-weekm single-blind run-in phase on candesartan cilexetil 16mg (for two weeks) and 32mg followed by an eight-week randomized, double-blind phase with three parallel treatment groups (candesartan cilexetil 32mg, candesartan cilexetil-HCT 32/12.5mg or candesartan cilexetil-HCT 32/25mg). Another study with a five-week placebo run-in, randomized patients to an eight-week double-blind treatment with placebo, HCT 25mg, candesartan cilexetil 32mg or candesartan cilexetil-HCT 32/25mg. A third study consisted of an eight-week double-blind treatment period with patients randomized to placebo, HCT 12.5 mg, candesartan cilexetil 32mg, or candesartan cilexetil-HCT 32/12.5mg.
Senior research physician Bjorn Karlson said: "the new higher dose strengths of Atacand Plus add to the broad range of Atacand hypertension options and offer physicians new solutions with proven efficacy and good tolerability to help their hypertensive patients achieve their blood pressure targets."
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