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
General Motors' Chevrolet, the first automotive brand to add 4G LTE connectivity across its entire vehicle portfolio, has now slashed its OnStar 4G LTE data plan pricing by up to 50 percent ahead of the upcoming 2016 Independence Day, the company said in a statement. Shares of Tractor Supply Co. (TSCO) slipped over 7 percent in the extended hours after the company issued a weak second-quarter guidance and lowered its annual outlook, due to weak sales of its seasonal products. For the second quarter, the company now expects earnings of $1.15 to $1.16 per share... Hard-disk driver maker Seagate Technology plc (STX) late Wednesday said it was cutting 1,600 jobs or about 3% of its global workforce to curb expenses. The company expects to save about $100 million a year, having a favorable impact on cost of revenue and operating expenses by about $48 million and...
comments powered by Disqus
Follow RTT