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A Randomised, Placebo-controlled, Double-blind, Parallel-group, Multicentre, Phase IIa Study to Explore the Relationship between QTcF Interval at First Dose (Loading Dose) and at Steady State after Tr...

Update Il y a 4 ans
Reference: EUCTR2007-007058-79

A Randomised, Placebo-controlled, Double-blind, Parallel-group, Multicentre, Phase IIa Study to Explore the Relationship between QTcF Interval at First Dose (Loading Dose) and at Steady State after Treatment with AZD1305 Extended-release Tablets or Placebo when given to Patients with Documented AF

Woman and Man

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Extract

The primary objective of this study is to explore the relationship between QTcF at first dose (loading dose) and QTcF at steady state after treatment with AZD1305, in order to identify outliers with regards to QTcF response when given to patients with documented AF but presently in stable SR for at least 2 h and a maximum of 28 days.

Inclusion criteria

  • The main purpose of this study is to investigate the feasibility to use a loading dose as a tool for identifying patients who may have an exaggerated QT response to AZD1305 and would therefore not be candidate for long term treatment

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