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NCT01026077 · ClinicalTrials.gov registry record

The Savella Pregnancy Registry

A clinical trial, sponsored by Syneos Health.

Terminated
Registry status
350
Enrollment target

NCT01026077: Clinical Trial study, sponsored by Syneos Health.

NCT01026077 is a clinical trial that was terminated before completion, run by Syneos Health. The registered enrollment target is 350 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01026077 was terminated before completion, sponsored by Syneos Health.

TERMINATED
Registry status
350 participants
Enrollment target

Study Summary

The Savella Pregnancy Registry is a US based registry designed to monitor pregnancies exposed to Savella (milnacipran HCI). This is an observational, exposure-registration and follow-up registry designed primarily to estimate the prevalence of major congenital anomalies, and secondarily to estimate the prevalence of recognized spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and any serious adverse pregnancy outcomes among pregnancies exposed to Savella as well as adverse outcomes observed during the first year of life in off-springs born from these exposed pregnancies. Live offspring are followed from birth until age one. The Savella Pregnancy Registry is sponsored by AbbVie (formerly Actavis PLC, Forest Laboratories Inc., and Allergan) and managed by Syneos Health.

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2009-11
Est. Completion 2024-10-09
Syneos Health

4 total trials

Why NCT01026077 stopped before completion

NCT01026077 is an observational study that tracks outcomes without assigning an intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01026077 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01026077 about?

NCT01026077 is a clinical study titled "The Savella Pregnancy Registry". The Savella Pregnancy Registry is a US based registry designed to monitor pregnancies exposed to Savella (milnacipran HCI). This is an observational, exposure-registration and follow-up registry designed primarily to estimate the prevalence of major congenital anomalies, and secondarily to estimate ...

What is the current status of trial NCT01026077?

This trial is currently terminated. The enrollment target is 350 participants. The study started on 2009-11. Estimated completion is 2024-10-09.

Who is sponsoring clinical trial NCT01026077?

This trial is sponsored by Syneos Health, which has 4 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01026077, the US trial registry maintained by the National Library of Medicine. NCT01026077 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.