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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: Completed Phase 4 study of Healthy, sponsored by Northwestern University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The relationship of urine osmolarity to each of three variables-plasma vasopressin. plasma tolvaptan and the ratio of plasma vasopressin to plasma tolvaptan- will be compared to determine which correlates best. The hypothesis predicts that the best fit will be between urine osmolarity and the ratio of plasma vasopressin to tolvaptan indicating that the variable effect of tolvaptan on urine output is due to competition with individual differences in plasma vasopressin.
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 |
What the finished NCT01973140 record still lists
NCT01973140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01973140's enrollment target sits among peer trials
17 929th of 1090 higher than 156 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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