![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » NOVOGEN DRUG IMPROVES CARDIOVASCULAR RISK
NOVOGEN DRUG IMPROVES CARDIOVASCULAR RISK
September 13, 2005
A Phase Ib clinical trial testing the Novogen cardiovascular investigational drug trans NV-04 has been completed at the Baker Heart Research Institute in Melbourne, Australia.
The trial results show significant improvement in blood pressure and arterial stiffness in patients at risk of cardiovascular events such as heart attack and stroke, but with no drug-related side-effects.
The study tested a metabolite of isoflavones, trans NV-04. This metabolite, an isoflavonoid compound synthesized by Novogen, was administered orally to 25 middle-aged men and women who were overweight and also suffered from at least two complications of fatness: abnormal blood fats, high blood glucose or raised blood pressure.
The trial was double-blind, so that neither subjects nor investigators knew the order in which the test isoflavone or a placebo were taken in a cross-over design in which the drug or placebo was tested over consecutive periods each of five weeks.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct