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NCT01004029 · ClinicalTrials.gov registry record · Phase 3
Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery
A Phase 3 study, sponsored by AMAG Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,740
- Enrollment target
NCT01004029 is a Phase 3 study that has completed, run by AMAG Pharmaceuticals. The registered enrollment target is 1,740 participants.
The verdict
NCT01004029, a Phase 3 study, has completed, sponsored by AMAG Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,740 participants
- Enrollment target
Study Summary
As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.
Interventions
- DRUG Vehicle
- DRUG Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,740 participants |
| Start Date | 2009-10 |
| Est. Completion | 2018-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01004029
The ClinicalTrials.gov registry entry for NCT01004029 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,740 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AMAG Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT01004029 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01004029 about?
NCT01004029 is a clinical study titled "Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery". As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singlet...
What is the current status of trial NCT01004029?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,740 participants. The study started on 2009-10. Estimated completion is 2018-10.
What interventions are being tested in trial NCT01004029?
The interventions under investigation include: Vehicle (DRUG), Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL (DRUG).
Who is sponsoring clinical trial NCT01004029?
This trial is sponsored by AMAG Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
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