Trial · NCT01973140
Effects of Tolvaptan in Healthy Adults
NCT01973140, Phase 4, Completed, Northwestern University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Tolvaptan in Healthy Adults. Trials, record NCT01973140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01973140
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Tolvaptan in Healthy Adults
- NCT number
- NCT01973140
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 17 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Healthy
- Interventions
- Tolvaptan, Hypertonic saline infusion
- First posted
- 2013-10-31
- Last updated
- 2026-10-15
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Plasma Osmolarity With Tolvaptan | 22 hours | Blood samples were collected at baseline, 1 hour post baseline, 2 hours post baseline, 3 hours post baseline, 4 hours post baseline, 5 hours post baseline, 6 hours post baseline, 8 hours post baseline, 10 hours post baseline, 14 hours post baseline, and 22 hours post baseline. Plasma osmolarity was measured from the blood samples. This Outcome Measure is reporting the data from the first visit when participants were given tolvaptan. |
| Primary | Change in Plasma Osmolarity With 3% Saline Infusion | 10 hours | Baseline data for visit 1 and visit 2 were collected separately at the start of each visit, this Outcome Measure is reporting data from the baseline collected at visit 2. Samples were collected at baseline, 1 hour post baseline, 2 hours post baseline, 3 hours post baseline, 4 hours post baseline, 5 hours post baseline, 6 hours post baseline, 8 hours post baseline, and 10 hours post baseline. Plasma osmolarity was measured from the blood samples. |
| Primary | Change in Plasma Sodium With Tolvaptan | 22 hours | Blood samples were collected at baseline, 1 hour post baseline, 2 hours post baseline, 3 hours post baseline, 4 hours post baseline, 5 hours post baseline, 6 hours post baseline, 8 hours post baseline, 10 hours post baseline, 14 hours post baseline, and 22 hours post baseline. Plasma sodium was measured from the blood samples. This Outcome Measure is reporting the data from the first visit when participants were given tolvaptan. |
| Primary | Change in Plasma Sodium With 3% Saline Infusion | 10 hours | Blood samples were collected at baseline, 1 hour post baseline, 2 hours post baseline, 3 hours post baseline, 4 hours post baseline, 5 hours post baseline, 6 hours post baseline, 8 hours post baseline, and 10 hours post baseline. Plasma sodium was measured from the blood samples. This Outcome Measure is reporting the data from the second visit when participants were given 3% saline infusion. |
| Secondary | Change in Plasma Vasopressin With Tolvaptan | 22 hours | Blood samples were collected at baseline, 1 hour post baseline, 2 hours post baseline, 3 hours post baseline, 4 hours post baseline, 5 hours post baseline, 6 hours post baseline, 8 hours post baseline, 10 hours post baseline, 14 hours post baseline, and 22 hours post baseline. Plasma vasopressin was measured from the blood samples. This Outcome Measure is reporting the data from the first visit when participants were given tolvaptan. |
| Secondary | Change in Plasma Vasopressin With 3% Saline Infusion | 10 hours | Blood samples were collected at baseline, 1 hour post baseline, 2 hours post baseline, 3 hours post baseline, 4 hours post baseline, 5 hours post baseline, 6 hours post baseline, 8 hours post baseline, and 10 hours post baseline. Plasma vasopressin was measured from the blood samples. This Outcome Measure is reporting the data from the second visit when participants were given 3% saline infusion. |
| Secondary | Change in Urine Osmolarity With Tolvaptan | 22 hours | Urine samples were collected at baseline, 1 hour post baseline, 2 hours post baseline, 3 hours post baseline, 4 hours post baseline, 5 hours post baseline, 6 hours post baseline, 8 hours post baseline, 10 hours post baseline, 14 hours post baseline, and 22 hours post baseline. Urine osmolarity was measured from the urine samples. This Outcome Measure is reporting the data from the first visit when participants were given tolvaptan. |
| Secondary | Change in Urine Osmolarity With 3% Saline Infusion | 10 hours | Urine samples were collected at baseline, 1 hour post baseline, 2 hours post baseline, 3 hours post baseline, 4 hours post baseline, 5 hours post baseline, 6 hours post baseline, 8 hours post baseline, and 10 hours post baseline. Urine osmolarity was measured from the urine samples. This Outcome Measure is reporting the data from the second visit when participants were given 3% saline infusion. |
| Secondary | Change in Thirst Ratings With Tolvaptan | 6 hours | Participants were asked to rate their thirst at baseline, 1 hour post baseline, 2 hours post baseline, 3 hours post baseline, 4 hours post baseline, 5 hours post baseline, and 6 hours post baseline. The participants were instructed to rate their thirst on a scale from 0-10 with a higher number indicating a higher level of thirst. This Outcome Measure is reporting the data from the first visit when participants were given tolvaptan. |
| Secondary | Change in Thirst Ratings With 3% Saline Infusion | 6 hours | Participants were asked to rate their thirst at baseline, 1 hour post baseline, 2 hours post baseline, 3 hours post baseline, 4 hours post baseline, 5 hours post baseline, and 6 hours post baseline. The participants were instructed to rate their thirst on a scale from 0-10 with a higher number indicating a higher level of thirst. This Outcome Measure is reporting the data from the second visit when participants were given 3% saline infusion. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01973140
GET https://conductscience.org/api/trials/v1/NCT01973140/registered