Clinical Trials for Cholesterol Treatment Halted
Pfizer has notified FDA of its suspension of a large Phase 3 trial evaluating torcetrapib/atorvastatin (T/A), an investigational cardiovascular therapy designed to raise levels of “good” HDL cholesterol.
The company's research turned up an increased mortality rate in patients receiving T/A compared with subjects receiving atorvastatin alone.
FDA stated that it fully supports Pfizer's decision to suspend this trial and that it will continue to work with the company and other sponsors developing molecules in this class of drugs to ensure that any safety issues are identified as early in the process as possible. The agency credited the system of biomedical research monitoring for effectively halting the trial and development of torcetrapib.