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NCT01346072 · ClinicalTrials.gov registry record · Phase 4
Pilot Study of Using Copeptin to Predict Response to Tolvaptan
A Phase 4 study of Heart Failure and Cardiovascular Diseases, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01346072 is a Phase 4 study of Heart Failure and Cardiovascular Diseases that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 21 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01346072, a Phase 4 study of Heart Failure and Cardiovascular Diseases, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot study will investigate the association between levels of the peptide copeptin and response to tolvaptan, a drug that blocks the action of the water retaining hormone vasopressin. The study will enroll stable outpatients with CHF with reduced LVEF (≤45) selected by targeting upper and lower quartile copeptin levels at screening (10 each). The treatment phase of the study will be a prospective, single-arm, open label protocol. All patients will receive active therapy consisting of a single oral dose of 30 mg of tolvaptan with body weight, fluid intake, and urine output monitored in a research unit for 24 hours. For analysis of study endpoints, patients in the single intervention arm will be stratified by a prospectively determined cut-point of copeptin level into two groups (≥10 versus \<10 pmol/L). The copeptin level used for the two group stratification will be the blinded copeptin value obtained at baseline from the hospital phase prior to administration of tolvaptan.
Conditions Studied
Interventions
- DRUG tolvaptan
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01346072
The ClinicalTrials.gov registry entry for NCT01346072 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which tolvaptan is the first listed.
NCT01346072 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01346072 about?
NCT01346072 is a clinical study titled "Pilot Study of Using Copeptin to Predict Response to Tolvaptan". This pilot study will investigate the association between levels of the peptide copeptin and response to tolvaptan, a drug that blocks the action of the water retaining hormone vasopressin. The study will enroll stable outpatients with CHF with reduced LVEF (≤45) selected by targeting upper and lowe...
What is the current status of trial NCT01346072?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2011-04. Estimated completion is 2014-12.
What conditions does trial NCT01346072 study?
This clinical trial studies the following conditions: Heart Failure, Cardiovascular Diseases, Heart Diseases.
What interventions are being tested in trial NCT01346072?
The interventions under investigation include: tolvaptan (DRUG).
Who is sponsoring clinical trial NCT01346072?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01346072 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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