Nov 18 2009
Clinical Data, Inc. (NASDAQ: CLDA) today announced that it has enrolled the first patient in its initial Phase III trial of Stedivaze™, a potential best-in-class vasodilator for use in cardiac stress testing. The study will evaluate the safety and efficacy of Stedivaze (apadenoson) for use as a pharmacologic stress agent in myocardial perfusion imaging (MPI), a method for detecting defects in the blood supply to the heart. The Phase III trial will also compare the tolerability of Stedivaze to adenosine, a standard pharmacologic stress agent used in MPI scans.
“The superior selectivity and pharmacokinetic profile of Stedivaze support its potential for improved tolerability compared to adenosine, as seen in Phase II studies,” said Carol R. Reed, M.D., Executive Vice President and Chief Medical Officer of Clinical Data. “Our Phase III trial is designed to demonstrate that these attributes, combined with a convenient, fixed, single-dose bolus administration, may offer the best-in-class pharmacologic agent for use in cardiac stress testing.”
The Phase III ASPECT Trial (Apadenoson Single Photo Emission Computed Tomography) is a randomized, double blind, active control study designed to determine whether Stedivaze is as effective as adenosine when used as a pharmacologic stress agent in SPECT MPI studies. Approximately 750 patients will be enrolled over an 18 to 24 month period at investigative sites in the U.S. Patients in the study will first undergo a clinically indicated SPECT MPI and then be randomized to receive a second SPECT MPI using either adenosine or Stedivaze. The incidence and severity of commonly reported side effects, such as shortness of breath, chest pain, dizziness, and headache, will also be evaluated to determine whether Stedivaze exhibits improved tolerability compared to adenosine.
Source Clinical Data, Inc.