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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
16 United States (US) sites/clinics; first subject signed informed consent on 9/11/07; last subject's final visit on 12/16/08

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Placebo	Placebo tablet given once daily for 21 days
Tolvaptan (15-60 mg)	Tolvaptan tablet 15-60 mg given once daily for 21 days

Participant Flow:   Overall Study

	Placebo	Tolvaptan (15-60 mg)
STARTED	28	29
COMPLETED	27	26
NOT COMPLETED	1	3
Adverse Event	0	2
Withdrawal by Subject	1	1

Reporting Groups

	Description
Placebo	Placebo tablet given once daily for 21 days
Tolvaptan (15-60 mg)	Tolvaptan tablet 15-60 mg given once daily for 21 days
Total	Total of all reporting groups

Baseline Measures

	Placebo	Tolvaptan (15-60 mg)	Total
Number of Participants   [units: participants]	28	29	57
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	6	6	12
>=65 years	22	23	45
Age   [units: years] Mean ± Standard Deviation	71.3  ± 9.7	71.1  ± 10.2	71.2  ± 9.9
Gender   [units: participants]
Female	19	15	34
Male	9	14	23
Region of Enrollment   [units: participants]
United States	28	29	57

1.  Primary:

Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)   [ Time Frame: baseline and Day 22 ]

2.  Secondary:

Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests   [ Time Frame: baseline and Day 22 ]

3.  Secondary:

Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test   [ Time Frame: baseline and Day 22 ]

4.  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   [ Time Frame: baseline and Day 22 ]

5.  Secondary:

Change From Baseline in Overall Neurocognitive Composite Score   [ Time Frame: baseline and Day 22 ]

6.  Secondary:

Change From Baseline in Gait Test (Timed Get-Up-and-Go Test)   [ Time Frame: baseline and Day 22 ]

7.  Secondary:

Change From Baseline in Postural Stability Test   [ Time Frame: baseline and Day 22 ]

8.  Secondary:

Change From Baseline in Serum Sodium; ITT Population   [ Time Frame: Baseline and Day 22 ]

9.  Secondary:

Number of Patients With Vital Sign Abnormalities: Blood Pressure   [ Time Frame: 28 days ]

10.  Secondary:

Number of Patients With Vital Sign Abnormalities: Pulse Rate   [ Time Frame: 28 days ]

11.  Secondary:

Number of Patients With Vital Sign Abnormalities: Body Weight   [ Time Frame: 28 days ]

12.  Secondary:

Number of Patients With Vital Sign Abnormalities: Body Temperature   [ Time Frame: 28 days ]

13.  Secondary:

Number of Patients With Hematology Laboratory Abnormalities: Hemoglobin   [ Time Frame: 28 days ]

14.  Secondary:

Number of Patients With Hematology Laboratory Abnormalities: Activated Partial Thromboplastin Time (aPTT)   [ Time Frame: 28 days ]

15.  Secondary:

Number of Patients With Hematology Laboratory Abnormalities: Lymphocytes   [ Time Frame: 28 days ]

16.  Secondary:

Number of Patients With Hematology Laboratory Abnormalities: Neutrophils   [ Time Frame: 28 days ]

17.  Secondary:

Number of Patients With Serum Chemistry Laboratory Abnormalities: Blood Urea Nitrogen (BUN)   [ Time Frame: 28 days ]

18.  Secondary:

Number of Patients With Serum Chemistry Laboratory Abnormalities: Uric Acid   [ Time Frame: 28 days ]

19.  Secondary:

Number of Patients With Serum Chemistry Laboratory Abnormalities: Cholesterol   [ Time Frame: 28 days ]

20.  Secondary:

Number of Patients With Serum Chemistry Laboratory Abnormalities: Glucose   [ Time Frame: 28 days ]

21.  Secondary:

Number of Patients With Serum Chemistry Laboratory Abnormalities: Magnesium   [ Time Frame: 28 days ]

22.  Secondary:

Number of Patients With Electrocardiogram (ECG) Abnormalities: QT >500 Milliseconds (Msec)   [ Time Frame: 28 days ]

23.  Secondary:

Number of Patients With Electrocardiogram (ECG) Abnormalities: QRS Interval   [ Time Frame: 28 days ]

24.  Secondary:

Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcB Increase 30-60 Msec   [ Time Frame: 28 days ]

25.  Secondary:

Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcF Increase 30-60 Msec   [ Time Frame: 28 days ]

26.  Secondary:

Number of Patients With Electrocardiogram (ECG) Abnormalities: ST Segment   [ Time Frame: 28 days ]

27.  Secondary:

Number of Patients With Electrocardiogram (ECG) Abnormalities: T Wave   [ Time Frame: 28 days ]

28.  Secondary:

Number of Patients With Electrocardiogram (ECG) Abnormalities: Right Bundle Branch Block (RBBB), Left Bundle Branch Block (LBBB), Myocardial Infarction (MI)   [ Time Frame: 28 days ]

29.  Secondary:

Number of Patients With Electrocardiogram (ECG) Abnormalities: Arrhythmia   [ Time Frame: 28 days ]