Review
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Pharmacodynamics of Sodium Nitroprusside During Prolonged Infusion in Pediatric Subjects [Internet]
Bethesda (MD): National Institute of Child Health and Human Development (US); 2012 Feb 1.
Affiliations
- PMID: 36516282
- Bookshelf ID: NBK587541
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Review
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Pharmacodynamics of Sodium Nitroprusside During Prolonged Infusion in Pediatric Subjects [Internet]
Excerpt
A Phase II, randomized, double-blind, withdrawal to placebo study examining the efficacy, safety, and tolerability of sodium nitroprusside (SNP) in pediatric subjects. Objectives were to determine the persistence of the effect of SNP on blood pressure during stable infusion regimens lasting at least 12 hours and to assess the potential for rebound hypertension during a 30 minute blinded phase following administration of SNP for at least 12 hours when infusion is temporarily discontinued.
[Table: see text]
Sections
- Letter to FDA
- Form FDA 1571
- 2. SYNOPSIS
- 4. GLOSSARY OF ABBREVIATIONS AND TERMS
- 5. ETHICS
- 6. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE
- 7. INTRODUCTION
- 8. STUDY OBJECTIVES
- 9. INVESTIGATIONAL PLAN
- 10. STUDY PATIENTS
- 11. EFFICACY EVALUATION
- 12. SAFETY EVALUATION
- 13. CONCLUSIONS
- 14. TABLES, FIGURES AND NARRATIVES
- 15. REFERENCES
- 16. APPENDICES
- Descriptive Supplementary Documents
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