The decision to the end trial, which was called Beacone, was recommended by an Independent Data Monitoring committee.

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This was the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th unblinded review of all study safety data.

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The data monitoring committee overseeing the trial said patients were unlikely to benefit from the treatment, and identified higher adverse events in the subjects receiving the drug compares to placebo.

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The outcome prompteed an independent data monitoring committee recommended patients who are on placebo should be offered Zytiga, which was approved to treat advanced prostate cancer patients who did not benefit from chemo.

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The action was based on the recommendation of the independent Data Monitoring Committee (DMC), after it found an increased risk for non-fatal stroke, renal complications, hyperkalemia, and hypotension in patients taking aliskiren after 18-24 months.

FORBES: ALTITUDE Study of Aliskiren Terminated Early by Novartis

Novartis was informed that the independent Data Monitoring Committee (DMC) overseeing ALTITUDE had recommended stopping the trial because Tekturna was unlikely to show any benefit, and potential safety concerns had been identified in these high-risk patients.

FORBES: ALTITUDE Study of Aliskiren Terminated Early by Novartis