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NCT01960413 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia
A Phase 2 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT01960413: Completed Phase 2 study, sponsored by Vanderbilt University Medical Center.
NCT01960413 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01960413, a Phase 2 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome measure is based on a 30% reduction, which would be \~106 ng/ml reduction. The study was designed with 25 in each group in order to explore all three aims and potential confounders. However, if the investigators are not able to accrue 25 subjects in each arm, the investigators would still be able to detect a 30% difference in sVCAM with 17 subjects in each group. The 95% confidence interval for detecting a 30% difference is between 204 ng/ml and 290 ng/ml (or an 18-42% reduct
Interventions
- DRUG Montelukast added to Hydroxyurea
- DRUG Placebo added to Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2013-11 |
| Est. Completion | 2018-03 |
| Phase | Phase 2 |
What the finished NCT01960413 record still lists
NCT01960413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Montelukast added to Hydroxyurea is the first listed.
NCT01960413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01960413 about?
NCT01960413 is a clinical study titled "Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia". 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.
What is the current status of trial NCT01960413?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2013-11. Estimated completion is 2018-03.
What interventions are being tested in trial NCT01960413?
The interventions under investigation include: Montelukast added to Hydroxyurea (DRUG), Placebo added to Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT01960413?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01960413's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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