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Trial · NCT01973140

Effects of Tolvaptan in Healthy Adults

NCT01973140, Phase 4, Completed, Northwestern University

3 sourcestrials-2026-11-12-0.5.0

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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

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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.

ListOutcomeTime frameDescription
PrimaryChange in Plasma Osmolarity With Tolvaptan22 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.
PrimaryChange in Plasma Osmolarity With 3% Saline Infusion10 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.
PrimaryChange in Plasma Sodium With Tolvaptan22 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.
PrimaryChange in Plasma Sodium With 3% Saline Infusion10 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.
SecondaryChange in Plasma Vasopressin With Tolvaptan22 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.
SecondaryChange in Plasma Vasopressin With 3% Saline Infusion10 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.
SecondaryChange in Urine Osmolarity With Tolvaptan22 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.
SecondaryChange in Urine Osmolarity With 3% Saline Infusion10 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.
SecondaryChange in Thirst Ratings With Tolvaptan6 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.
SecondaryChange in Thirst Ratings With 3% Saline Infusion6 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.

Outcomes0

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.

PMIDListed asSource
1987308BACKGROUNDPubMed
4727463BACKGROUNDPubMed
16843083BACKGROUNDPubMed
17925589BACKGROUNDPubMed
19535650BACKGROUNDPubMed
21283124BACKGROUNDPubMed

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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