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

This study has been completed.
University of Utah
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: January 2001


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

Condition Intervention
Pre-eclampsia Drug: magnesium sulfate Drug: nimodipine

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 2000
Study Start Date: September 1995
Estimated Study Completion Date: August 2000
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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


--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


  • 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
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Please refer to this study by its identifier: NCT00004399

Sponsors and Collaborators
FDA Office of Orphan Products Development
University of Utah
Study Chair: Michael Anthony Belfort University of Utah
  More Information Identifier: NCT00004399     History of Changes
Other Study ID Numbers: 199/13249
Study First Received: October 18, 1999
Last Updated: March 24, 2015

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

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Antihypertensive Agents
Vasodilator Agents processed this record on June 23, 2017