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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
Clinical Study Report
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Study Sponsor; Gregory Hammer, Scott Schulman, and David Drover. Ravinder Anand and Andrew Lewandowski.
Author Information and AffiliationsA 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.
| Protocol: | NICHD-2003-09-LT (SNP2) |
| Development Phase: | II |
| Investigational Product: | Sodium Nitroprusside (SNP) |
| IND Number: | 71,979 |
| Date of Inclusion of First Subject: | October 15, 2008 |
| Date of Completion of Last Subject: | November 18, 2010 |
| Indication Studied: | Hypertension in pediatric subjects, who require long term blood pressure control |
| Methodology: | Randomized, multicenter, double-blind, placebo-controlled study evaluating the pharmacodynamics of sodium nitroprusside during prolonged infusion in pediatric subjects |
Contents
- 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
- 9.1. Overall Design and Plan Description
- 9.2. Discussion of Study Design and Choice of Control Groups
- 9.3. Selection of Study Population
- 9.4. Treatments
- 9.5. Efficacy and Safety Assessments
- 9.6. Data Quality Assurance
- 9.7. Statistical Methods and Determination of Sample Size
- 9.8. Changes in the Conduct of the Study or Planned Analyses
- 10. STUDY PATIENTS
- 11. EFFICACY EVALUATION
- 12. SAFETY EVALUATION
- 13. CONCLUSIONS
- 14. TABLES, FIGURES AND NARRATIVES
- 15. REFERENCES
- 16. APPENDICES
- Descriptive Supplementary Documents
Study data is available on the DASH repository at https://dash.nichd.nih.gov/study/14
This study was regsitered on ClinicalTrails.gov at https://clinicaltrials.gov/ct2/show/NCT00621816
This study was conducted with Good Clinical Practices (GCP) and applicable regulatory requirements, including the archiving of essential documents.
All unpublished information contained within this report is confidential and the sole property of the NICHD.
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- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel ...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
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