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Safe and Effective Medicines for Children Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (2012) / Chapter Skim
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Appendix E: Written Requests for Studies of Pediatric Hypertension: Longitudinal Changes in FDA Specifications
Pages 381-386

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From page 381...
... to inves tigate potential drug treatments for pediatric hypertension. It begins with a summary of key elements in the written requests issued in the first 30 months after pediatric exclusivity provisions became effective in July 1998.
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From page 382...
... . KEY ELEMENTS SPECIFIED IN WRITTEN REQUESTS/ AMENDMENTS ISSUED FROM 1998 TO 2000 Requested trials: • – Dose-ranging trial with hypertensive pediatric patients – Trial of pharmacokinetics (PKs)
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From page 383...
... A slope analysis would be used for the first phase and then, if the dose-response curve is flat, an analysis of the second phase would determine whether a blood pressure effect existed. The result would be considered interpretable no matter what the outcome, so long as the sample size for the withdrawal phase was adequate.
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From page 384...
... CHANGES ADDED OR ELEMENTS MODIFIED, 2006 Interim analyses allowed to assess variability according to a pre • specified rule to adjust the sample size to achieve the specified
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From page 385...
... Dissemination of information: The written request and medical, • statistical, and clinical pharmacology reviews will be posted on the FDA website, and the trial will be registered at ClinicalTrials.gov. Labeling: Regardless of whether the studies demonstrate that the • drug is safe and effective or whether the results of such studies with the pediatric population are inconclusive, the sponsor must submit labeling to include information about the results of the studies.
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From page 386...
... 2008. Safety of pla cebo controls in pediatric hypertension trials.
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Key Terms

  • written requests
  • pediatric hypertension
  • blood pressure
  • trial designs
  • positive slope

  • randomized withdrawal
  • changes added
  • elements modified
  • significantly positive
  • interim analyses

  • withdrawal phase
  • drug treatments
  • pharmacology reviews
  • pediatric patients
  • written request

  • hypertension trials
  • treatment period
  • lower doses
  • compounding information
  • minimum percentages

  • pediatric exclusivity
  • corrected change
  • specifying minimum
  • treatment phase
  • investigate drug

  • requests tended
  • requests issued
  • blinded analysis
  • controlled trial
  • partially unblinded


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