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Factorial trial for treating sleepy overweight or obese sleep apnea patients who cannot use standard treatments comparing hypocaloric diet with high protein/ low glycemic index diet for fat mass reduction and simultaneously comparing armodafinil with placebo for improving simulated driving ability and neuro-behavioural functioning

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Trial Profile

Factorial trial for treating sleepy overweight or obese sleep apnea patients who cannot use standard treatments comparing hypocaloric diet with high protein/ low glycemic index diet for fat mass reduction and simultaneously comparing armodafinil with placebo for improving simulated driving ability and neuro-behavioural functioning

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 11 Jun 2018

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At a glance

  • Drugs Armodafinil (Primary)
  • Indications Obesity; Sleep apnoea syndrome
  • Focus Pharmacogenomic; Therapeutic Use
  • Acronyms DEAR

Most Recent Events

  • 18 May 2018 Primary endpoint (loss of fat mass (grams) as measured by a DXA scan at 12 months.Timepoint: Baseline, 6 months) has been met, according to results published in the American Journal of Respiratory and Critical Care Medicine.
  • 18 May 2018 Primary endpoint has (Improvement in simulated driving ability quantified by standard deviation in lane position as measured by the AusEd driving simulator in the last 30 minutes of a 90 minute drive.Timepoint: Baseline, 6 months) not been met, according to results published in the American Journal of Respiratory and Critical Care Medicine.
  • 18 May 2018 Primary endpoint (Primary outcome for pharmaceutical trial: Improvement in simulated driving ability quantified by standard deviation in lane position as measured by the AusEd driving simulator in the last 30 minutes of a 90 minute drive.) has been met, according to results published in the American Journal of Respiratory and Critical Care Medicine.

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