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Calcium Channel Blocker

Nifedipine for Preterm Labor (Nifedipine Trial)

Phase 3
Waitlist Available
Led By Josiah S Hawkins, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Approved for 5 Other Conditions
All Individual Drugs Already Approved

Summary

The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.

Eligible Conditions
  • Preterm Labor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment2 Interventions
Women with preterm labor will receive placebo.
Group II: NifedipineExperimental Treatment2 Interventions
Women with preterm labor will receive nifedipine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Nifedipine
FDA approved

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,080 Previous Clinical Trials
1,056,220 Total Patients Enrolled
Chet E Wells, MDStudy DirectorUniversity of Texas Southwestern Medical Center
Josiah S Hawkins, MDPrincipal InvestigatorKaiser Medical Center, Oakland, CA
~8 spots leftby Nov 2025
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