Trial · NCT02009878

A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

NCT02009878, Phase 1, Phase 2, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2016-05-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH). Trials, record NCT02009878. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02009878

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
NCT number: NCT02009878
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 30 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
Interventions: tolvaptan
First posted: 2013-12-12
Last updated: 2016-05-16
Results first posted: 2016-05-16

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.	Baseline to Day 2	Maximal increase in serum sodium is summarized below by tolvaptan dose. Blood samples for determination of plasma concentrations of tolvaptan were collected predose and at 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours postdose on Day 1 or at Early Termination (ET).
Primary	Time of Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.	Baseline to Day 2	Time of maximal increase in serum sodium is summarized in the table below by tolvaptan dose. Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.
Secondary	Cmax (Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma.	Baseline to Day 2	Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.
Secondary	Tmax (Time to Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma	Baseline to Day 2	Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.
Secondary	AUC Infinity (Area Under the Concentration-time Curve From Time Zero to Infinity) for Tolvaptan in Plasma	Baseline to Day 2	Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. If an indwelling catheter was utilized, saline flushes were used. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.
Secondary	Change From Baseline in Serum Sodium Concentrations	Baseline and Day 2	Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.
Secondary	Change From Baseline in Fluid Intake From 0-6 Hours, 0-12 Hours and 0-24 Hours	Baseline and Day 2	Fluid intake was monitored on Day 0 (times relative to Day 1 dosing), and Day 1 at intervals of 0 to 6, 6 to 12, and 12 to 24 hours postdose. Fluid intake included fluid used for dosing (study medication and any concomitant medication); food items that included any significant amounts of water (e.g., Jello \[including Gelatin and Jelly dessert\] and soup) was added to the total fluid intake. Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.
Secondary	Change From Baseline in Fluid Balance (Fluid Intake Minus Urine Output) From 0-6 Hours, 0-12 Hours and 0-24 Hours.	2 days	Fluid intake was monitored on Day 0 (times relative to Day 1 dosing), and Day 1 at intervals of 0 to 6, 6 to 12, and 12 to 24 hours postdose. Fluid intake included fluid used for dosing (study medication and any concomitant medication); food items that included any significant amounts of water (e.g., Jello \[including Gelatin and Jelly dessert\] and soup) was added to the total fluid intake. Urine was collected for baseline comparison on Day 0 for the 24 hour prior to Day 1 dosing at intervals of 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12 hours, and 12 to 24 hours relative to the Day 1 dosing time. Fluid balance was determined as fluid intake minus urine output.
Secondary	Change From Baseline in Cumulative Urine Volume at 0-6 Hours, 0-12 Hours and 0-24 Hours.	2 days	Urine was collected for baseline comparison on Day 0 for the 24 hour prior to Day 1 dosing at intervals of 0 to 2, 2 to 4, 4, to 6, 6, to 8, 8, to 12, and 12 to 24 hours relative to Day 1 dosing time. Urine was collected on Day 1 at intervals of 0 to 2,2 to 4, 4 to 6, 6 to 8, 8 to 12, and 12 to 24 hours postdose. For the start of the urine collection on Day 0, a window of 15 to 40 minutes prior to the assigned dosing time was acceptable, with the 0 to 24 hour collection period on Day 1 starting 24 hours after the start time on Day 0. Participants were asked to void immediately prior to the end of the collection interval. The volume of individual voids were measured and recorded prior to refrigerating. All voids in a collection interval were pooled at the end of the collection interval, at which time the volume was determined, recorded and an aliquot taken for osmolality, sodium, potassium, and creatinine assessments.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.	Baseline to Day 2	PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.	mmol/L	MEAN
SECONDARY	Cmax (Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma.	Baseline to Day 2	PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.	ng/mL	MEAN
SECONDARY	Tmax (Time to Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma	Baseline to Day 2	PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.	hours	MEDIAN
SECONDARY	AUC Infinity (Area Under the Concentration-time Curve From Time Zero to Infinity) for Tolvaptan in Plasma	Baseline to Day 2	PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.	ng·h/mL	MEAN
SECONDARY	Change From Baseline in Serum Sodium Concentrations	Baseline and Day 2	PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.	mmol/L	MEAN
PRIMARY	Time of Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.	Baseline to Day 2	PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.	hours	MEDIAN
SECONDARY	Change From Baseline in Fluid Intake From 0-6 Hours, 0-12 Hours and 0-24 Hours	Baseline and Day 2	PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.	mL	MEAN
SECONDARY	Change From Baseline in Fluid Balance (Fluid Intake Minus Urine Output) From 0-6 Hours, 0-12 Hours and 0-24 Hours.	2 days	PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.	mL	MEAN
SECONDARY	Change From Baseline in Cumulative Urine Volume at 0-6 Hours, 0-12 Hours and 0-24 Hours.	2 days	PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.	mL	MEAN

Source ClinicalTrials.gov

Results by group63

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.	Tolvaptan 3.75 mg	3.6	Standard Deviation 3.3	mmol/L
Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.	Tolvaptan 7.5 mg	5.3	Standard Deviation 2.5	mmol/L
Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.	Tolvaptan 15 mg	7.9	Standard Deviation 5.3	mmol/L
Cmax (Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma.	Tolvaptan 3.75 mg	37.7	Standard Deviation 12.6	ng/mL
Cmax (Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma.	Tolvaptan 7.5 mg	107	Standard Deviation 48.9	ng/mL
Cmax (Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma.	Tolvaptan 15 mg	157	Standard Deviation 68.1	ng/mL
Tmax (Time to Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma	Tolvaptan 3.75 mg	1.50	Full Range 0.95 to 4.00	hours
Tmax (Time to Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma	Tolvaptan 7.5 mg	2.00	Full Range 1.00 to 4.00	hours
Tmax (Time to Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma	Tolvaptan 15 mg	2.00	Full Range 0.97 to 3.00	hours
AUC Infinity (Area Under the Concentration-time Curve From Time Zero to Infinity) for Tolvaptan in Plasma	Tolvaptan 3.75 mg	244	Standard Deviation 90.7	ng·h/mL

1 to 10 of 63Source ClinicalTrials.gov

See all 63 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tolvaptan 3.75 mg	10
Overall Study	STARTED	Tolvaptan 7.5 mg	11
Overall Study	STARTED	Tolvaptan 15 mg	9
Overall Study	COMPLETED	Tolvaptan 3.75 mg	10
Overall Study	COMPLETED	Tolvaptan 7.5 mg	10
Overall Study	COMPLETED	Tolvaptan 15 mg	9
Overall Study	NOT COMPLETED	Tolvaptan 3.75 mg	0
Overall Study	NOT COMPLETED	Tolvaptan 7.5 mg	1
Overall Study	NOT COMPLETED	Tolvaptan 15 mg	0

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Dizziness	Nervous system disorders	Tolvaptan 3.75 mg	0	10
other	Dizziness	Nervous system disorders	Tolvaptan 7.5 mg	1	10
other	Dizziness	Nervous system disorders	Tolvaptan 15 mg	1	9
other	Insomnia	Psychiatric disorders	Tolvaptan 3.75 mg	0	10
other	Insomnia	Psychiatric disorders	Tolvaptan 7.5 mg	0	10
other	Insomnia	Psychiatric disorders	Tolvaptan 15 mg	1	9
other	Polyuria	Renal and urinary disorders	Tolvaptan 3.75 mg	0	10
other	Polyuria	Renal and urinary disorders	Tolvaptan 7.5 mg	0	10
other	Polyuria	Renal and urinary disorders	Tolvaptan 15 mg	1	9
serious	Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Tolvaptan 3.75 mg	0	10

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tolvaptan 3.75 mg
Total, all-cause mortality	Tolvaptan 7.5 mg
Total, all-cause mortality	Tolvaptan 15 mg
Total, other adverse events	Tolvaptan 3.75 mg	0	10
Total, other adverse events	Tolvaptan 7.5 mg	1	10
Total, other adverse events	Tolvaptan 15 mg	3	9
Total, serious adverse events	Tolvaptan 3.75 mg	0	10
Total, serious adverse events	Tolvaptan 7.5 mg	0	10
Total, serious adverse events	Tolvaptan 15 mg	1	9

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

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