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Clinical Trials/EUCTR2015-005811-34-NL
EUCTR2015-005811-34-NL
Active, not recruiting
Phase 1

Pregnancy reLated Acute hyperTension INtervention Action: a randomized trial comparing labetalol and nicardipine in women with acute hypertension in pregnancy (Platina-trial) - PLATINA

VU Medical Center, Amsterdam0 sites472 target enrollmentMay 18, 2018
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ConditionsTo asses optimal treatment of hypertension of hypertensive disorders in pregnancyTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsNicardipine

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
To asses optimal treatment of hypertension of hypertensive disorders in pregnancy
Sponsor
VU Medical Center, Amsterdam
Enrollment
472
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 18, 2018
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
VU Medical Center, Amsterdam

Eligibility Criteria

Inclusion Criteria

  • •In order to be eligible to participate in this study, a subject must meet the following criteria:
  • •\-Pregnant women
  • •\-\>18 years of age
  • •\-pregnant women with severe pregnancy induced hypertension (PIH) or severe pre\-eclampsia (PE) at any gestational age. Preeclampsia is defined as hypertension with proteinuria \= 0\.3 g/24 hrs.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 472
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range 0

Exclusion Criteria

  • •A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • •\- Maternal age at eligibility \<18 years
  • •\- Fetal abnormalities
  • •\- Multiple pregnancy in current pregnancy
  • •\- Clinically relevant pulmonary edema, defined as pulmonary failure or distress requiring oxygen supplementation (more than 10 liters) and/or pulse oximetry of \<94%.

Outcomes

Primary Outcomes

Not specified

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