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NCT01973140 · ClinicalTrials.gov registry record · Phase 4
Effects of Tolvaptan in Healthy Adults
A Phase 4 study of Healthy, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT01973140 is a Phase 4 study of Healthy that has completed, run by Northwestern University. The registered enrollment target is 17 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01973140, a Phase 4 study of Healthy, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
Tolvaptan is one of new class of medications approved for treatment of low blood sodium (hyponatremia). It works by interfering with the effect of the antidiuretic hormone, vasopressin, thereby increasing urine output and decreasing body water. However, the magnitude of these effects vary from person to person. Thus, the efficacy of tolvaptan is less reliable than an infusion of a concentrated salt solution for emergency, short term treatment of hyponatremia. This study is designed to test 3 hypotheses about the variable efficacy of tolvaptan. 1. The variable effect on urine output is due to individual differences in blood vasopressin which counteracts the effects of tolvaptan. 2. The differences in blood vasopressin are due to individual differences in the amount secreted in response to a rise in blood sodium. 3. The variable effect on blood sodium is due mainly to the variable effect on urine output and can be corrected by maintaining water intake below urine output. The study has 2 parts and will be performed in 12 healthy adult males. 1. Six subjects will receive tolvaptan at a dose of 60 mg by mouth and six subjects will receive tolvaptan at 30 mg by mouth. Blood and urine will be collected hourly for 6 hours and water will be ingested in prescribed amounts. For the next 16 hours, subjects will drink at will and blood and urine will be collected 4 more times. 2. One week later, the same subjects will receive a concentrated salt solution (3% saline) by vein for 6 hours. During this time, blood and urine will be collected hourly but drinking will not be permitted. For the next 4 hours, subjects will be allowed to drink at will while blood and urine are collected twice more. The volume, concentration and creatinine content of each urine will be determined. Blood will be analyzed for sodium, vasopressin and, in the first study, tolvaptan.
Conditions Studied
Interventions
- DRUG Tolvaptan
- DRUG Hypertonic saline infusion
Study Locations (1)
Illinois
- Clinical Research Unit Northwestern Memorial Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-03 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01973140
The ClinicalTrials.gov registry entry for NCT01973140 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Tolvaptan is the first listed.
NCT01973140 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT01973140 about?
NCT01973140 is a clinical study titled "Effects of Tolvaptan in Healthy Adults". Tolvaptan is one of new class of medications approved for treatment of low blood sodium (hyponatremia). It works by interfering with the effect of the antidiuretic hormone, vasopressin, thereby increasing urine output and decreasing body water. However, the magnitude of these effects vary from perso...
What is the current status of trial NCT01973140?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2013-11. Estimated completion is 2016-03.
What conditions does trial NCT01973140 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01973140?
The interventions under investigation include: Tolvaptan (DRUG), Hypertonic saline infusion (DRUG).
Who is sponsoring clinical trial NCT01973140?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01973140 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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