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Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia

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ClinicalTrials.gov Identifier: NCT00004399
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
University of Utah
Information provided by:
FDA Office of Orphan Products Development

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

OBJECTIVES:

I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.


Condition or disease Intervention/treatment Phase
Pre-eclampsia Drug: magnesium sulfate Drug: nimodipine Not Applicable

Detailed Description:

PROTOCOL OUTLINE: This is a randomized, international, multicenter study. Patients are randomized to receive either nimodipine or magnesium sulfate.

Arm I: Patients receive nimodipine by mouth every 4 hours. Treatment is continued until 24 hours post-partum.

Arm II: Patients receive a loading dose of magnesium sulfate IV for 20 minutes, followed by continuous infusion of magnesium sulfate. Treatment is continued until 24 hours post-partum.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 2000 participants
Allocation: Randomized
Primary Purpose: Prevention
Study Start Date : September 1995
Study Completion Date : August 2000

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically diagnosed severe preeclampsia at risk for eclamptic convulsions with the following criteria:
  • Blood pressure greater than 160/110 mmHg OR Mean arterial pressure of 126 mmHg
  • Proteinuria greater than 5 g/24 hr
  • Epigastric pain OR Right upper quadrant pain AST/ALT greater than 70 U/L
  • Severe headache and/or scotomata
  • Thrombocytopenia as evidenced by: Platelet count less than 100,000/mm3 Disseminated intravascular coagulation Microangiopathic hemolytic anemia Oliguria (less than 400 mL/day or 30 mL/hr)
  • Pulmonary edema

--Prior/Concurrent Therapy--

  • No prior/concurrent magnesium sulfate or dihydropyridine agents
  • No other concurrent antiseizure medications

--Patient Characteristics--

  • Age: Not specified
  • Performance status: Not specified
  • Hematopoietic: See Disease Characteristics
  • Hepatic: See Disease Characteristics
  • Renal: No severe renal failure See Disease Characteristics
  • Cardiovascular: No history of angina or myocardial infarction No cardiac dysfunction No history or sign of congestive cardiac failure No arrhythmia with ventricular rate less than 60 bpm See Disease Characteristics
  • Pulmonary: See Disease Characteristics

--Other:--

  • No severe mental or physical disorder that may affect therapy
  • Not allergic to drugs with chemical structure similar to nimodipine or magnesium sulfate
  • No evidence of fetal distress or fetal anomalies
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004399


Sponsors and Collaborators
FDA Office of Orphan Products Development
University of Utah
Investigators
Study Chair: Michael Anthony Belfort University of Utah
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00004399     History of Changes
Other Study ID Numbers: 199/13249
UU-FDR001061
BCM-FDR001061
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: January 2001

Keywords provided by FDA Office of Orphan Products Development:
cardiovascular and respiratory diseases
hypertensive disorder
pre-eclampsia
rare disease

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Nimodipine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
 Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Antihypertensive Agents
Vasodilator Agents