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Clinical Trials/CTRI/2013/12/004238
CTRI/2013/12/004238
Other
Phase 3

An open, multicentric prospective clinical trial to evaluate the efficacy and safety of Ibutilide fumarate injection in the treatment of Atrial Fibrillation or Flutter.

Zuventus Healthcare Ltd0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: I48- Atrial fibrillation and flutter

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: I48- Atrial fibrillation and flutter
Sponsor
Zuventus Healthcare Ltd
Status
Other
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Above 18 yrs of age, with no previous exposure to investigational drug.
  • •2\.Weighing \> 60 kg
  • •3\.Patients with sustained Atrial Fibrillation or Flutter lasting for \>1hr to \<60 days.
  • •4\.Patients developing Atrial Fibrillation or Flutter post cardiac surgery (1\-7 days after surgery).
  • •5\.Corrected QT interval (QTc) \<\=440 ms on a 12 lead electrocardiogram (ECG).
  • •6\.Haemodynamic stability (systolic blood pressure \>\=90 mm Hg and diastolic blood pressure \>\=60 mm Hg and \< 105 mm Hg).
  • •7\.Ventricular rate \>60bpm

Exclusion Criteria

  • •1\.History of Hyperthyroidism.
  • •2\.Heart Rate \<60 bpm.
  • •3\.History or evidence of unstable angina pectoris, bronchospastic disease or myocardial infarction.
  • •4\.Known sinus node dysfunction, second or third degree atrioventricular (AV) block, bundle branch block, Wolff\-Parkinson\-White syndrome and/or torsade de pointes.
  • •5\.Concurrent treatment with verapamil, diltiazem, or drugs that prolong the QT interval
  • •6\.Recent major hemorrhage (within 6 months).
  • •7\.Coagulopathy
  • •8\.Pregnant or breast feeding
  • •9\.Acute congestive heart failure
  • •10\.Hypokalemia or hyperkalemia (Electrolyte abnormalities)

Outcomes

Primary Outcomes

Not specified

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