Trial · NCT00550459

Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients

NCT00550459, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2011-04-28

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients. Trials, record NCT00550459. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00550459

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Trial

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

Title: Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients
NCT number: NCT00550459
Status: Completed
Phases: Phase 3
Enrollment: 57 participants, actual
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions: Hyponatremia
Interventions: Tolvaptan, Placebo
First posted: 2007-10-29
Last updated: 2011-04-28
Results first posted: 2011-04-28
Limitations and caveats: Pilot study powered only for serum Na+ improvements. Trial lacked sufficient power to detect changes in neurocognitive test scores and SF-12 and HDS outcomes.

Source ClinicalTrials.gov

Registered outcomes29

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)	baseline and Day 22	Change from baseline to Day 22 in sum of all speed domain Z-scores:Reaction Time (Simple=recognize "yes" 50 times;Choice=recognize "yes" or "no" 50 times;Digit Vigilance=match 45 digits);Psychomotor Speed (Morse Tapping=tap button for 30 seconds with right \& left hands);Processing Speed (Rapid Visual Information Processing=detect consecutive sequences of 3 odd or 3 even digits;Numeric Working Memory=recognize numbers from series of 5 digits among 30;Word Recognition=remember 15 prior learned words from 30 total;results age-matched to healthy controls from Cognitive Drug Research normative data
Secondary	Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests	baseline and Day 22	Change from baseline in the individual neurocognitive domains Z-score for Reaction Time in Computer Tests (simple reaction time test, choice reaction time test, digit vigilance test); ITT population
Secondary	Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test	baseline and Day 22	Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Psychomotor Speed (mean tap rate of Morse tapping test); ITT population
Secondary	Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test	baseline and Day 22	Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test; ITT population
Secondary	Change From Baseline in Overall Neurocognitive Composite Score	baseline and Day 22	Change from Baseline to Day 22 in the overall Neurocognitive Composite Score (NCS)comprising the sum of 7 neurocognitive domain Z-scores (Reaction Time, Psychomotor Speed, Processing Speed, Continuity of Attention, Working Memory/Executive Functions, Quality of Episodic Verbal Memory, and Postural Stability); ITT population
Secondary	Change From Baseline in Gait Test (Timed Get-Up-and-Go Test)	baseline and Day 22	Change from baseline to Day 22 in Gait Test (Timed Get-Up-and-Go Test=time it takes for a seated subject to rise from a chair, walk 3 meters, walk around an object and return to sit in chair. Values: under 10 sec (no difficulties), 10 to 20 sec (starting to have balance difficulty), over 30 sec (at high risk for falls and dependent in most activities of daily living and mobility); test assesses risk to elderly subjects of falling and higher scores in seconds indicate higher risk of falling; ITT population
Secondary	Change From Baseline in Postural Stability Test	baseline and Day 22	Change from baseline to Day 22 in Postural Stability Test Z-score (This test measures gross motor control. The ability to stand upright without moving is assessed using the SWAY meter that is modeled on the Wright Ataxiameter. A cord from the meter is attached to the subject who is required to stand as still as possible with feet apart and eyes closed for 1 minute. The test is then repeated with eyes open for 1 minute. The outcomes of these tests are combined and measured as a movement Z-score. Higher result=better postural stability); ITT population
Secondary	Change From Baseline in Serum Sodium; ITT Population	Baseline and Day 22	Change from Baseline to Day 22 in Serum Sodium; ITT population
Secondary	Number of Patients With Vital Sign Abnormalities: Blood Pressure	28 days	Incidence of abnormal systolic \& diastolic blood pressure values post-baseline (abnormal systolic values: \>=180 mmHg + increase of \>=20 mmHg, \<= 90 mmHg + decrease \>=20 mmHg; abnormal diastolic values: \>=105 mmHg+increase of \>=15 mmHg, \<=50 mmHg + decrease of \>= 15 mmHg)
Secondary	Number of Patients With Vital Sign Abnormalities: Pulse Rate	28 days	Incidence of abnormal pulse rate post-baseline \[abnormal values: \>=120 beats per minute (bpm) + increase of \>=15 bpm; \<=50 bpm + decrease of \>=15 bpm\]

1 to 10 of 29Source ClinicalTrials.gov

See all 29 registered outcomes

Outcomes29

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)	baseline and Day 22	Analysis based upon observed cases (OC).	Z-score	MEAN
SECONDARY	Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests	baseline and Day 22	ITT population with OC	Z-score	MEAN
SECONDARY	Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test	baseline and Day 22	ITT population with OC	Z-score	MEAN
SECONDARY	Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test	baseline and Day 22	ITT population with OC	Z-score	MEAN
SECONDARY	Change From Baseline in Overall Neurocognitive Composite Score	baseline and Day 22	ITT population with OC	Z-score	MEAN
SECONDARY	Change From Baseline in Gait Test (Timed Get-Up-and-Go Test)	baseline and Day 22	ITT population with OC	Seconds	MEAN
SECONDARY	Change From Baseline in Postural Stability Test	baseline and Day 22	ITT population with LOCF (this group includes missing values)	Z-score	MEAN
SECONDARY	Change From Baseline in Serum Sodium; ITT Population	Baseline and Day 22	ITT population with OC	mEq/L	MEAN
SECONDARY	Number of Patients With Vital Sign Abnormalities: Blood Pressure	28 days	Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication	participants	NUMBER
SECONDARY	Number of Patients With Vital Sign Abnormalities: Pulse Rate	28 days	Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication	participants	NUMBER

1 to 10 of 29Source ClinicalTrials.gov

See all 29 outcomes

Results by group58

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

Outcome	Group	Value	Spread	Units
Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)	Placebo	0.20	Standard Deviation 0.61	Z-score
Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)	Tolvaptan (15-60 mg)	0.39	Standard Deviation 0.49	Z-score
Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests	Placebo	0.21	Standard Deviation 0.86	Z-score
Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests	Tolvaptan (15-60 mg)	0.33	Standard Deviation 0.41	Z-score
Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test	Placebo	0.04	Standard Deviation 0.36	Z-score
Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test	Tolvaptan (15-60 mg)	0.31	Standard Deviation 0.46	Z-score
Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test	Placebo	0.24	Standard Deviation 0.75	Z-score
Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test	Tolvaptan (15-60 mg)	0.48	Standard Deviation 0.91	Z-score
Change From Baseline in Overall Neurocognitive Composite Score	Placebo	0.19	Standard Deviation 0.39	Z-score
Change From Baseline in Overall Neurocognitive Composite Score	Tolvaptan (15-60 mg)	0.30	Standard Deviation 0.39	Z-score

1 to 10 of 58Source ClinicalTrials.gov

See all 58 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	28
Overall Study	STARTED	Tolvaptan (15-60 mg)	29
Overall Study	COMPLETED	Placebo	27
Overall Study	COMPLETED	Tolvaptan (15-60 mg)	26
Overall Study	NOT COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	Tolvaptan (15-60 mg)	3

Source ClinicalTrials.gov

Adverse events38

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	Events
other	Dermatitis	Skin and subcutaneous tissue disorders	Placebo	2	28	2
other	Dermatitis	Skin and subcutaneous tissue disorders	Tolvaptan (15-60 mg)	0	29	0
other	Dizziness	Nervous system disorders	Placebo	2	28	4
other	Dizziness	Nervous system disorders	Tolvaptan (15-60 mg)	2	29	2
other	Dry Mouth	Gastrointestinal disorders	Placebo	0	28	0
other	Dry Mouth	Gastrointestinal disorders	Tolvaptan (15-60 mg)	2	29	2
other	Fatigue	General disorders	Placebo	2	28	2
other	Fatigue	General disorders	Tolvaptan (15-60 mg)	2	29	2
other	Nasopharyngitis	Infections and infestations	Placebo	1	28	1
other	Nasopharyngitis	Infections and infestations	Tolvaptan (15-60 mg)	2	29	2

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Tolvaptan (15-60 mg)
Total, other adverse events	Placebo	13	28
Total, other adverse events	Tolvaptan (15-60 mg)	17	29
Total, serious adverse events	Placebo	1	28
Total, serious adverse events	Tolvaptan (15-60 mg)	2	29

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 comparisons22

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tolvaptan (15-60 mg) vs Placebo: Number of Patients With Hematology Laboratory Abnormalities: Lymphocytes	Trial comparisons
Tolvaptan (15-60 mg) vs Placebo: Number of Patients With Serum Chemistry Laboratory Abnormalities: Glucose	Trial comparisons
Tolvaptan (15-60 mg) vs Placebo: Number of Patients With Hematology Laboratory Abnormalities: Hemoglobin	Trial comparisons
Tolvaptan (15-60 mg) vs Placebo: Number of Patients With Serum Chemistry Laboratory Abnormalities: Blood Urea Nitrogen (BUN)	Trial comparisons
Tolvaptan (15-60 mg) vs Placebo: Number of Patients With Electrocardiogram (ECG) Abnormalities: ST Segment	Trial comparisons
Tolvaptan (15-60 mg) vs Placebo: Number of Patients With Vital Sign Abnormalities: Pulse Rate	Trial comparisons
Tolvaptan (15-60 mg) vs Placebo: Number of Patients With Electrocardiogram (ECG) Abnormalities: QRS Interval	Trial comparisons
Tolvaptan (15-60 mg) vs Placebo: Number of Patients With Vital Sign Abnormalities: Blood Pressure	Trial comparisons
Tolvaptan (15-60 mg) vs Placebo: Number of Patients With Hematology Laboratory Abnormalities: Activated Partial Thromboplastin Time (aPTT)	Trial comparisons
Tolvaptan (15-60 mg) vs Placebo: Number of Patients With Serum Chemistry Laboratory Abnormalities: Cholesterol	Trial comparisons

1 to 10 of 22

See all 22 trial comparisons

Tests3

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Rapid Visual Information Processing	Primary outcome	ConductCognition
Choice Reaction Time	Secondary outcome	ConductCognition
Simple Reaction Time	Secondary outcome	ConductCognition

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.

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