logo
Share SHARE
FONT-SIZE Plus   Neg

Amgen Reports Top-Line Results Of Phase 3 Sensipar/Mimpara EVOLVE Trial

Amgen Inc. (AMGN) announced top-line results of the Phase 3 EVOLVE trial, evaluating Sensipar/Mimpara for the reduction of the risk of mortality and cardiovascular or CV events among 3,883 patients with secondary hyperparathyroidism and chronic kidney disease receiving dialysis.

The trial's primary endpoint was time to the composite event comprising all-cause mortality or first non-fatal cardiovascular event, including myocardial infarction, hospitalization for unstable angina, heart failure or peripheral vascular event. Though patients in the Sensipar/Mimpara arm experienced numerically fewer composite primary events, the results were not statistically significant, and the study failed to meet its primary endpoint in the intent-to-treat analysis.

"Amgen embarked on the EVOLVE trial to understand whether treating secondary HPT with Sensipar/Mimpara could positively impact the high rates of mortality and cardiovascular events among patients with CKD receiving dialysis," said Sean Harper, M.D., executive vice president of Research and Development at Amgen.

The most frequently reported adverse events in the Sensipar/Mimpara arm of the trial were consistent with the known safety profile of this therapy and included nausea, vomiting and hypocalcemia.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
HSBC is reportedly laying off about 100 of its senior investment bankers worldwide, as the banking giant strives to curb operating costs. According to reports, the London-headquartered bank will eliminate managing director and director level employees at the Global Banking and Markets division, as... Samsung Electronics Co., Ltd. (SMSN.L, SSNNF.OB, SSNLF.OB) will reportedly blame faulty batteries for last year's Galaxy Note 7 fiasco. According to a Wall Street Journal report, Samsung's investigation of Galaxy Note 7 smartphones found that some batteries were irregularly sized while others had... Federal investigators have closed their probe of a fatal crash that involved a Tesla Motors Inc. car eight months ago. The regulators said they have found no safety defects in the vehicle's automated driving system and that Tesla's Autopilot-enabled vehicles did not need to be recalled.
comments powered by Disqus
Follow RTT