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NCT01089062 · ClinicalTrials.gov registry record · Phase 1
Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure
A Phase 1 study of Healthy, sponsored by Allergan.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01089062: Completed Phase 1 study of Healthy, sponsored by Allergan.
NCT01089062 is a Phase 1 study of Healthy that has completed, run by Allergan. The registered enrollment target is 24 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01089062, a Phase 1 study of Healthy, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.
Primary Outcome
AUC(0-2hrs) (Area Under the Curve, time 0-2 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg\*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.
Conditions Studied
Interventions
- DRUG MAP0004
- DRUG IV Placebo (Saline)
- DRUG Placebo Inhaler
- DRUG IV Dihydroergotamine Mesylate (DHE)
Study Locations (1)
North Carolina
- Duke Clinical Research Unit - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
What the finished NCT01089062 record still lists
NCT01089062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 4 interventions - of which MAP0004 is the first listed.
NCT01089062 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01089062 about?
NCT01089062 is a clinical study titled "Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure". Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.
What is the current status of trial NCT01089062?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-03. Estimated completion is 2010-12.
What conditions does trial NCT01089062 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01089062?
The interventions under investigation include: MAP0004 (DRUG), IV Placebo (Saline) (DRUG), Placebo Inhaler (DRUG), IV Dihydroergotamine Mesylate (DHE) (DRUG).
Who is sponsoring clinical trial NCT01089062?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01089062 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01089062's enrollment target sits among peer trials
24 791st of 1090 higher than 254 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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