Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01327066 · ClinicalTrials.gov registry record · Phase 1
Electrocardiographic (ECG) Safety Study of Droxidopa at Clinical and Supratherapeutic Dose
A Phase 1 study, sponsored by Chelsea Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT01327066: Completed Phase 1 study, sponsored by Chelsea Therapeutics.
NCT01327066 is a Phase 1 study that has completed, run by Chelsea Therapeutics. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01327066, a Phase 1 study, has completed, sponsored by Chelsea Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
The purpose of this study is define the electrocardiographic (ECG) effects of Droxidopa at clinical (600 mg) and supratherapeutic (2000 mg) doses compared with placebo and moxifloxacin in healthy male and female subjects.
Primary Outcome
The primary ECG endpoint is the time matched, placebo adjusted change from Baseline in QT interval corrected using an individual correction method (QTcI) (ΔΔQTcI). The QTcI method provides an optimization of QT correction for HR as compared with fixed exponent approaches such as Bazett (QTcB) or Fridericia (QTcF).
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG Droxidopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
What the finished NCT01327066 record still lists
NCT01327066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01327066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01327066 about?
NCT01327066 is a clinical study titled "Electrocardiographic (ECG) Safety Study of Droxidopa at Clinical and Supratherapeutic Dose". The purpose of this study is define the electrocardiographic (ECG) effects of Droxidopa at clinical (600 mg) and supratherapeutic (2000 mg) doses compared with placebo and moxifloxacin in healthy male and female subjects.
What is the current status of trial NCT01327066?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2011-03. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01327066?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), Droxidopa (DRUG).
Who is sponsoring clinical trial NCT01327066?
This trial is sponsored by Chelsea Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01327066's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02630121 · 52 participants · Phase 4
Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea
- NCT03629171 · 52 participants · Phase 2
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
- NCT04128748 · 52 participants · Phase 1
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
- NCT04150497 · 52 participants · Phase 1
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia