CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Montelukast added to Hydroxyurea +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/NCT01960413
NCT01960413Phase 2Completed
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Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia (Also Known as the Montelukast Trial in Sickle Cell Anemia)

Vanderbilt University Medical Center·interventional·Posted Oct 10, 2013·Updated Mar 26, 2019

In Brief

A Phase 2 clinical trial evaluating Montelukast added to Hydroxyurea and Placebo added to Hydroxyurea for Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0). Completed, enrolled 46 participants across 2 sites.

Detailed Summary

In this feasibility trial, the investigators will compare participants treated with montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
CountriesUnited States
CollaboratorsMedical College of Wisconsin, Versiti Blood Health

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 10, 2013
Enrollment StartNov 1, 2013
Primary CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.7 years ago

Interventions

Montelukast added to Hydroxyureadrug

Placebo added to Hydroxyureadrug