The FDA announced that Pfizer Inc has suspended its phase 3 trial evaluating an investigational cardiovascular therapy, torcetrapib/atorvastatin, due to an increased rate of mortality in trial participants receiving the combination compared with those receiving atorvastatin (a statin) alone.
According to the FDA, Pfizer Inc had the appropriate protections in place for patients receiving torcetrapib in this trial, including informed consent and an independent data and safety monitoring board. This board found the increased rate of death through its monthly analyses of mortality data from the trial.
Hampton T. Heart Drug Trial Halted. JAMA. 2007;297(4):354. doi:10.1001/jama.297.4.354-d
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