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Monoxadine study halted

November 1, 1999

Monoxadine study halted

More participants than expected died a few months ago during a clinical mortality trial of sustained-release Monoxadine, and Eli Lilly of Indianapolis, marketer for the selective imidazoline receptor agonist put a stop to the trial. The immediate release delivery version of the experimental heart failure drug is available in Europe for hypertension control.

"We used the sustained-release form in addition to standard therapy for the active group," says Judy Moore, a Lilly spokeswoman. "The placebo group got just standard therapy. The number of deaths that occurred in the Monoxadine group was greater than in the placebo group, so we agreed with Solvay that the trial should be terminated." (Belgium-based Solvay is the drug’s manufacturer.) There were 1,860 patients enrolled in the trial. At the time the trial was halted, 25 had died among the standard therapy group, and 46 had died in the Monoxadine group.