CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Ticagrelor Dose 1a + Dose 2a +1 moredrug
Likely dose
Not stated in 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/NCT02214121
NCT02214121Phase 2Completed

Multicenter, Open-label, Randomised, Pharmacokinetic (PK) and Pharmacodynamic (PD) Dose-ranging Phase II Study of Ticagrelor Followed by a Double-blind, Randomised, Parallel-group, Placebo-controlled 4 Weeks Extension Phase in Paediatric Patients With Sickle Cell Disease

AstraZeneca·interventional·Posted Aug 12, 2014·Updated Dec 14, 2018

In Brief

A Phase 2 clinical trial evaluating Ticagrelor Dose 1a + Dose 2a and Ticagrelor Dose 1b + Dose 2b for Investigation of Platelet Aggregation in Paediatric Patients With Sickle Cell Disease. Completed, enrolled 46 participants across 18 sites in 6 countries.

Detailed Summary

The purpose of this Phase II dose-ranging study is to investigate pharmacokinetic (PK) and pharmacodynamic (PD) properties of various doses of ticagrelor followed by 4 weeks of twice-daily treatment in paediatric patients with sickle cell disease

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Kenya, Lebanon, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 12, 2014
Enrollment StartSep 11, 2014
Primary CompletionFeb 27, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.9 years ago

Interventions

Ticagrelor Dose 1a + Dose 2adrug

Ticagrelor Dose 1a and ticagrelor Dose 2a single doses + 1 week ticagrelor repeated dosing followed by 4 weeks repeated dosing ticagrelor or placebo.

Ticagrelor Dose 1b + Dose 2bdrug

Ticagrelor Dose 1b and ticagrelor Dose 2b single doses + 1 week ticagrelor repeted dosing followed by 4 weeks repeated dosing ticagrelor or placebo.