Alteon Amends Action II Trial

9 December 1996

Alteon, upon review of its Phase III ACTION (A Clinical Trial In Overt Nephropathy) trial data, has amended its protocol for ACTION II.

In the ACTION II pivotal trial, which is evaluating the use of pimagedine in type II diabetics with overt nephropathy, all patients on the high-dose arm of the trial will be moved onto the ongoing low-dose arm because of dose-related adverse events which have been recorded in some of the more frail elderly subjects. It will continue as a placebo-controlled, blinded study and will not enroll any more patients.

The Phase III ACTION I trial, which is studying the effects of pimagedine in type I diabetics with overt nephropathy, will not be altered. The trial finished in August of this year, however, all the patients will remain on the drug until the middle of 1998, when the study will be finally completed and the data will be released.

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