CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Anagrelide 0.5 mg +3 moredrug
Likely dose
Anagrelide 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01552928
NCT01552928Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, 4-Period Crossover Trial to Assess the Effect of Anagrelide Hydrochloride on QT/QTc Interval in Healthy Men and Women.

Shire·interventional·Posted Mar 13, 2012·Updated Jun 9, 2021

In Brief

A Phase 1 clinical trial evaluating Anagrelide 0.5 mg, Anagrelide 2.5 mg, and 2 other interventions for Healthy. Completed, enrolled 60 participants across 1 site.

Detailed Summary

According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated for their ability to prolong the QT interval which represents the duration of ventricular depolarization and subsequent repolarization. The primary objective of the study is to assess the effect of anagrelide on QT/QTc interval following a therapeutic and supratherapeutic dose of anagrelide when compared to placebo and a positive control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesFrance
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 13, 2012
Enrollment StartMar 29, 2012
Primary CompletionJul 25, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.3 years ago

Interventions

Anagrelide 0.5 mgdrug

0.5mg Anagrelide single oral dose

Anagrelide 2.5 mgdrug

2.5mg Anagrelide single oral dose

Moxifloxacindrug

400 mg Moxifloxacin single oral dose

Placebodrug

Anagrelide placebo + Moxifloxacin placebo single oral dose