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NCT01766154 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Evaluation of Tirofiban Using a Single High-Dose Bolus In Subjects With Varying Degrees of Renal Function
A Phase 1 study of Renal Insufficiency, sponsored by Medicure.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT01766154 is a Phase 1 study of Renal Insufficiency that has completed, run by Medicure. The registered enrollment target is 25 participants, below the 100-participant average among 22 other Renal Insufficiency trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01766154, a Phase 1 study of Renal Insufficiency, has completed, sponsored by Medicure.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate tirofiban concentration in the blood over a period of 24 hours after tirofiban administration. Subjects with varying degrees of renal insufficiency (i.e. kidney function) will be included in the study. Tirofiban is known to be cleared from the blood by the kidneys and so people with kidney problems clear tirofiban to a slower extent compared to people without kidney problems. By comparing the tirofiban concentration profile between subjects with healthy kidney function versus with impaired kidney function, a tirofiban dosing recommendation for subjects with impaired kidney function can be made. This is a non-randomized, single-center, open-label study. A single dose of tirofiban (25 µg/kg administered intravenously over a 3 min period) will be administered to subjects with normal renal function (\>90 mL/min CrCl), moderate (30-59 mL/min CrCl), and severe (\<30 mL/min CrCl) renal impairment with non-dialysis-dependent renal insufficiency
Conditions Studied
Interventions
- DRUG Tirofiban
Study Locations (1)
Florida
- Avail Clinical Research, LLC - DeLand
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01766154
The ClinicalTrials.gov registry entry for NCT01766154 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 100-participant average among 22 other Renal Insufficiency trials with a reported enrollment target (75% lower). The listed sponsor is Medicure, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Renal Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which Tirofiban is the first listed.
NCT01766154 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT01766154 about?
NCT01766154 is a clinical study titled "Pharmacokinetic Evaluation of Tirofiban Using a Single High-Dose Bolus In Subjects With Varying Degrees of Renal Function". The purpose of this study is to evaluate tirofiban concentration in the blood over a period of 24 hours after tirofiban administration. Subjects with varying degrees of renal insufficiency (i.e. kidney function) will be included in the study. Tirofiban is known to be cleared from the blood by the ki...
What is the current status of trial NCT01766154?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2013-01. Estimated completion is 2013-03.
What conditions does trial NCT01766154 study?
This clinical trial studies the following conditions: Renal Insufficiency.
What interventions are being tested in trial NCT01766154?
The interventions under investigation include: Tirofiban (DRUG).
Who is sponsoring clinical trial NCT01766154?
This trial is sponsored by Medicure, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01766154 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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