In December 2014, the company completed a Phase III actual use trial, which was intended to simulate the OTC use of Lipitor (atorvastatin calcium) 10mg.
The program was terminated as the trial did not meet its primary objectives of showing patient compliance with the direction to check their low-density lipoprotein cholesterol (LDL-C) level and, after checking their LDL-C level, took appropriate action based on their test results.
Pfizer said in a statement: "Based on dialogue with the FDA about the program and analysis of this data, the program was terminated."
Initiated in October 2013, the Phase III actual use trial enrolled around 1,311 patients.