The Duke Clinical Research Institute has been enlisted to launch a major new study of Johnson & Johnson's Natrecor to test its safety and efficacy. Natrecor is a therapy designed to treat patients whose hearts stop beating properly, leaving them gasping for breath. J&J bought Scios three years ago for $2.4 billion primarily to gain control of Natrecor. Some 7,000 volunteers will be enlisted in the trial, which is being initiated after a string of reports raised questions about possible links to kidney failure and death. Enrollment in the study will begin in early 2007. Duke will collaborate with the Cleveland Clinic Cardiovascular Coordinating Center.
"The ASCEND-HF trial will add to the growing body of evidence and will provide important clinical data about the impact of Natrecor on outcomes that matter: most importantly, symptom relief, readmission to the hospital for heart failure and death," said Dr. Robert Califf, the director of DCRI and vice chancellor for clinical research and professor of medicine in the Division of Cardiology at Duke University Medical Center.
- read the AP report on the study