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NCT01873885 · ClinicalTrials.gov registry record · Phase 1
Phase 1, Randomized, Double-Blind, Placebo-Controlled Exploratory Study That Will Assess the Safety, Tolerability, Pharmacokinetics and Hemodynamic Response to a Single 30 Minute Intravenous Infusion of Vasomera™ (PB1046) in Adult Subjects With Stage 1 or 2 Essential Hypertension
A Phase 1 study, sponsored by PhaseBio Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01873885: Completed Phase 1 study, sponsored by PhaseBio Pharmaceuticals.
NCT01873885 is a Phase 1 study that has completed, run by PhaseBio Pharmaceuticals. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01873885, a Phase 1 study, has completed, sponsored by PhaseBio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This study is an exploratory Phase 1 randomized, double-blind (Investigator and study subject and 2-D echo endpoint assessor), placebo-controlled single IV infusion dose escalation study that will enroll up to approximately 32 subjects with stage 1 or 2 essential hypertension.
Primary Outcome
To evaluate the safety and tolerability of single ascending doses of Vasomera administered as a 30 minute intravenous (IV) infusion to subjects with stage 1 or stage 2 essential hypertension. * Incidence and severity of adverse events (AEs) and their relationship to Vasomera (including AEs of interest, i.e., incidence and severity of gastrointestinal effects, and infusion site reactions) * Changes in vital signs, ECGs, safety laboratory parameters, heart rhythm via telemetry monitor from baseli
Interventions
- DRUG Placebo Single IV (Intravenous) Infusion
- DRUG Experimental: Single IV Infusion Vasomera (PB1046)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT01873885 record still lists
NCT01873885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Single IV (Intravenous) Infusion is the first listed.
NCT01873885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01873885 about?
NCT01873885 is a clinical study titled "Phase 1, Randomized, Double-Blind, Placebo-Controlled Exploratory Study That Will Assess the Safety, Tolerability, Pharmacokinetics and Hemodynamic Response to a Single 30 Minute Intravenous Infusion of Vasomera™ (PB1046) in Adult Subjects With Stage 1 or 2 Essential Hypertension". This study is an exploratory Phase 1 randomized, double-blind (Investigator and study subject and 2-D echo endpoint assessor), placebo-controlled single IV infusion dose escalation study that will enroll up to approximately 32 subjects with stage 1 or 2 essential hypertension.
What is the current status of trial NCT01873885?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2013-06. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01873885?
The interventions under investigation include: Placebo Single IV (Intravenous) Infusion (DRUG), Experimental: Single IV Infusion Vasomera (PB1046) (DRUG).
Who is sponsoring clinical trial NCT01873885?
This trial is sponsored by PhaseBio Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01873885's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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
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