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NCT00554359 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation and Safety Study of I5NP in Patients Undergoing Major Cardiovascular Surgery
A Phase 1 study, sponsored by Quark Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00554359 is a Phase 1 study that has completed, run by Quark Pharmaceuticals. The registered enrollment target is 16 participants.
The verdict
NCT00554359, a Phase 1 study, has completed, sponsored by Quark Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic study. The study will be conducted in approximately 8-10 centers in the United States and Switzerland. Up to 32 patients who have undergone major cardiovascular surgery will participate. Patients will receive a single IV injection of I5NP or placebo following cardiovascular surgery. I5NP will be administered 4 hours (+/- 30 minutes) following removal of the cardiopulmonary bypass machine (CBM). The duration of the study is approximately 44 days, inclusive of a 14 day screening period. Patients will be contacted by phone at 6 and 12 months for follow-up questions. Patient visits are screening, day of surgery, hospital in-patient Days 1, 2, 3 and Day 7 or hospital discharge. Safety follow-up will continue until 30 days post-surgery. 2 phone calls will be made at 6 and 12 months after date of surgery.
Interventions
- DRUG placebo
- DRUG I5NP (a small interfering RNA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2007-08 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00554359
The ClinicalTrials.gov registry entry for NCT00554359 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Quark Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00554359 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00554359 about?
NCT00554359 is a clinical study titled "A Dose Escalation and Safety Study of I5NP in Patients Undergoing Major Cardiovascular Surgery". This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic study. The study will be conducted in approximately 8-10 centers in the United States and Switzerland. Up to 32 patients who have undergone major cardiovascular surgery will participate. Patients will receive a ...
What is the current status of trial NCT00554359?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2007-08. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00554359?
The interventions under investigation include: placebo (DRUG), I5NP (a small interfering RNA) (DRUG).
Who is sponsoring clinical trial NCT00554359?
This trial is sponsored by Quark Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
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