Dose Reduction and/or Interruption Sample Clauses

Dose Reduction and/or Interruption. During Trial Participation‌ Dose reduction is an option for subjects who experience adverse events that are sufficiently severe to cause the subject to consider discontinuation or to cause the investigator concern about the subject’s ability to continue in the study. It should be recognized that caloric restriction resulting in rapid weight loss (independent of any specific drug mechanisms) carries the potential to negatively affect growth. Due to the potential of the study drug to cause significant weight loss which may affect growth in adolescents, investigators should actively monitor the subject’s rate of weight loss and growth (using height and weight), and implement a down-titration of study drug should rates of weight loss in a given subject exceed rates that are deemed safe. For subjects with baseline BMI 95-98th percentile, reduce study drug dosage when BMI is < 85th percentile or when weight loss exceeds an average of 2 lbs (0.9 kg) per week. For subjects with baseline BMI ≥ 99th percentile, reduce study drug when weight loss exceeds an average of 2 lbs (0.9 kg)/week. Dose reduction is implemented through the IWRS, and will be done without breaking the blind. Subjects assigned to the mid-dose may be reduced down to the low-dose and those assigned to the top-dose may be reduced down to the mid-dose, and if necessary, the low-dose in a blinded manner. Dose reduction is not an option for subjects who experience intolerable adverse events related to study medication during the first week of titration (Week 1) during the initial randomization; these subjects will be withdrawn from treatment. When dose reduction is not appropriate or when dose interruption may be required due to events unrelated to study treatment, subjects may temporarily discontinue from treatment (up to 7 days) on one or more occasions. Dose interruptions longer than 7 days are possible with agreement from the medical monitor. All subjects undergoing dose interruptions for any duration may be titrated back up to the original dose level based on discretion of the investigator. If study drug has been discontinued for 2 weeks or more, a new titration kit should be ordered through IWRS to resume treatment. Subjects who have a drug holiday following dose reduction due to study medication intolerance will be retitrated to the dose specified for use after dose reduction. For subjects having a drug holiday due to events unrelated to treatment, attempts should be made to retitrate to the ini...
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Related to Dose Reduction and/or Interruption

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