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NCT02978534 · ClinicalTrials.gov registry record
Pharmacokinetics of Quetiapine Across Pregnancy and Postpartum
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 4
- Enrollment target
NCT02978534 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 4 participants.
The verdict
NCT02978534 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 4 participants
- Enrollment target
Study Summary
The widespread and common use of quetiapine in childbearing and pregnant women demands more data to inform dosing and toxicity in pregnancy. The new FDA Pregnancy and Lactation Labeling Final Rule (PLLR) will go into effect on June 30th, 2015 and will replace the prior A, B, C, D, and X categories. Additionally, the PLLR will require information to aid prescribing decisions in three categories 1) Pregnancy (including labor and delivery), 2) Lactation, and 3) Females and Males of Reproductive Potential. The pregnancy category will include a subsection that will describe pharmacokinetic and pharmacodynamic characteristics of the medication in pregnancy, fetal risk, and data quality. The data collected in this study will update the FDA pregnancy pharmacokinetic section for quetiapine and inform physicians that prescribe to childbearing women.
Interventions
- DRUG Quetiapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2016-03 |
| Est. Completion | 2020-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02978534
The ClinicalTrials.gov registry entry for NCT02978534 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Quetiapine is the first listed.
NCT02978534 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02978534 about?
NCT02978534 is a clinical study titled "Pharmacokinetics of Quetiapine Across Pregnancy and Postpartum". The widespread and common use of quetiapine in childbearing and pregnant women demands more data to inform dosing and toxicity in pregnancy. The new FDA Pregnancy and Lactation Labeling Final Rule (PLLR) will go into effect on June 30th, 2015 and will replace the prior A, B, C, D, and X categories. ...
What is the current status of trial NCT02978534?
This trial is currently completed. The enrollment target is 4 participants. The study started on 2016-03. Estimated completion is 2020-12.
What interventions are being tested in trial NCT02978534?
The interventions under investigation include: Quetiapine (DRUG).
Who is sponsoring clinical trial NCT02978534?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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