- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00550459
Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients (INSIGHT)
26. april 2011 opdateret af: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Pilot, Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Effects of Titrated Oral Tolvaptan 15, 30, or 60 mg QD on Cognitive and Neurological Function in Elderly Hyponatremic Patients
Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Subjects will be randomized, with stratification by baseline sodium <130 or ≥ 130 mEq/L[mmol/L] to receive either tolvaptan 15 mg tablet or matching placebo tablet at doses of 15, 30 or 60 mg for 21 days.
During this period, fluid restrictions should be loosened or suspended, until the subject's response to therapy can be evaluated, typically over the first few days of therapy.
Fluid restriction may be reinstituted at any time in subjects whose sodium fails to improve or worsens with study therapy.
A forced-titration up to 60 mg of study drug by day 3 to 7 will be based on the subject's serum sodium Subjects entering the study with a serum sodium concentration less than 130 mEq/L[mmol/L] may be fluid restricted if necessary at the discretion of the Investigator.
Subjects should be monitored closely during the first 24 hours of treatment for dosing titration.
The total dosing duration will be up to 21 days (plus 3 day treatment window).
Subjects will return to the clinic on Day 22 (+3 days) for assessments and will complete a follow-up visit on Day 28 (+2 days).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
57
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
-
Hawthorne, California, Forenede Stater, 90250
- Sarah. S. Olelewe, MD
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Vista, California, Forenede Stater, 92083
- Progressive Clinical Research
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80907
- Pikes Peak Cardiology
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Florida
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Largo, Florida, Forenede Stater, 33770
- Innovative Research of West FL
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Punta Gorda, Florida, Forenede Stater, 33950
- Coastal Nephrology Assoc. Research Center
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Georgia
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Conyers, Georgia, Forenede Stater, 30094
- Rockdale Medical Research Associates
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Louisiana
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Natchitoches, Louisiana, Forenede Stater, 71457
- Otis Barnum, DO
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58106
- Lillestol Research, LLC
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29201
- Carolina Research Associates
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Tennessee
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Lebanon, Tennessee, Forenede Stater, 37087
- Wayne O. Wells, MD
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Texas
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Houston, Texas, Forenede Stater, 77043
- Memorial Clinical Associates
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- Mitchell Rosner, MD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Women and men 50 years of age or older.
- Serum Sodium ≥123 and ≤ 134 mEq/L [mmol/L]at screening and baseline.
- Subjects with serum sodium concentrations ≥118 and ≤122 mEq/L[mmol/L] at screening and baseline may be entered into the trial based on consultation and approval from the study medical monitor.
Exclusion Criteria:
- Conditions or history which may present a safety concern to the subject or their offspring or extreme susceptibility to hypotension with sudden fluid loss (aquaresis).
- Hyponatremia that is acute, easily reversible, artifactual, or due to a condition not associated with vasopressin excess or likely to respond to aquaretic therapy.
- Conditions associated with an independent imminent risk of morbidity and mortality.
- Conditions which may confound the assessment of endpoints, history of poor compliance, participation in a clinical trial believed by the PI or Sponsor likely to confound endpoint assessments.
- Conditions which may confound primary endpoints of cognitive function.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: 1
Placebo tablet given once a day for 21 days
|
Placebo tablet given once daily for 21 days
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Aktiv komparator: 2
Tolvaptan 15 mg-60 mg tablet given once a day for 21 days.
|
15-60 mg oral tablet given once a day for 21 days.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)
Tidsramme: 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
|
baseline and Day 22
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests
Tidsramme: 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
|
baseline and Day 22
|
Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test
Tidsramme: 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
|
baseline and Day 22
|
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
Tidsramme: 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
|
baseline and Day 22
|
Change From Baseline in Overall Neurocognitive Composite Score
Tidsramme: 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
|
baseline and Day 22
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Change From Baseline in Gait Test (Timed Get-Up-and-Go Test)
Tidsramme: 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
|
baseline and Day 22
|
Change From Baseline in Postural Stability Test
Tidsramme: 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
|
baseline and Day 22
|
Change From Baseline in Serum Sodium; ITT Population
Tidsramme: Baseline and Day 22
|
Change from Baseline to Day 22 in Serum Sodium; ITT population
|
Baseline and Day 22
|
Number of Patients With Vital Sign Abnormalities: Blood Pressure
Tidsramme: 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)
|
28 days
|
Number of Patients With Vital Sign Abnormalities: Pulse Rate
Tidsramme: 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]
|
28 days
|
Number of Patients With Vital Sign Abnormalities: Body Weight
Tidsramme: 28 days
|
Incidence of clinically significant body weight change post-baseline (defined as change upward or downward of >=7%)
|
28 days
|
Number of Patients With Vital Sign Abnormalities: Body Temperature
Tidsramme: 28 days
|
Incidence of potentially clinically significant changes in body temperature post-baseline (defined as an increase of >=1.1 to >=38.3 degrees Celsius)
|
28 days
|
Number of Patients With Hematology Laboratory Abnormalities: Hemoglobin
Tidsramme: 28 days
|
Incidence of clinically significant hemoglobin abnormalities post-baseline (normal range=11.8-16.8
g/dL)
|
28 days
|
Number of Patients With Hematology Laboratory Abnormalities: Activated Partial Thromboplastin Time (aPTT)
Tidsramme: 28 days
|
Incidence of potentially clinically significant Activated Partial Thromboplastin Time (aPTT) levels post-baseline (normal range=22-34 seconds)
|
28 days
|
Number of Patients With Hematology Laboratory Abnormalities: Lymphocytes
Tidsramme: 28 days
|
Incidence of potentially clinically significant lymphocyte count post-baseline (normal range = 16-46%)
|
28 days
|
Number of Patients With Hematology Laboratory Abnormalities: Neutrophils
Tidsramme: 28 days
|
Incidence of potentially clinically significant neutrophil count post-baseline (normal range=1.8-8
thousands/microliter)
|
28 days
|
Number of Patients With Serum Chemistry Laboratory Abnormalities: Blood Urea Nitrogen (BUN)
Tidsramme: 28 days
|
Incidence of potentially clinically significant BUN levels post-baseline (normal range=7-30 mg/dL)
|
28 days
|
Number of Patients With Serum Chemistry Laboratory Abnormalities: Uric Acid
Tidsramme: 28 days
|
Incidence of potentially clinically significant uric acid levels post-baseline (normal range=4-8.5
mg/dL)
|
28 days
|
Number of Patients With Serum Chemistry Laboratory Abnormalities: Cholesterol
Tidsramme: 28 days
|
Incidence of potentially clinically significant cholesterol levels post-baseline (normal range=0-199 mg/dL)
|
28 days
|
Number of Patients With Serum Chemistry Laboratory Abnormalities: Glucose
Tidsramme: 28 days
|
Incidence of potentially clinically significant glucose levels post-baseline (normal range=70-125 mg/dL)
|
28 days
|
Number of Patients With Serum Chemistry Laboratory Abnormalities: Magnesium
Tidsramme: 28 days
|
Incidence of potentially clinically significant magnesium levels post-baseline (normal range=1.2-2
mEq/L)
|
28 days
|
Number of Patients With Electrocardiogram (ECG) Abnormalities: QT >500 Milliseconds (Msec)
Tidsramme: 28 days
|
Incidence of potentially clinically significant ECG abnormalities (QT>500 msec) post-baseline
|
28 days
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Number of Patients With Electrocardiogram (ECG) Abnormalities: QRS Interval
Tidsramme: 28 days
|
Incidence of potentially clinically significant ECG abnormalities involving QRS interval (change > 100 msec)
|
28 days
|
Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcB Increase 30-60 Msec
Tidsramme: 28 days
|
Incidence of potentially clinically significant ECG abnormalities (QTcB increase 30-60 msec)
|
28 days
|
Number of Patients With Electrocardiogram (ECG) Abnormalities: QTcF Increase 30-60 Msec
Tidsramme: 28 days
|
Incidence of potentially clinically significant ECG abnormalities (QTcF increase 30-60 msec post-baseline)
|
28 days
|
Number of Patients With Electrocardiogram (ECG) Abnormalities: ST Segment
Tidsramme: 28 days
|
Incidence of potentially clinically significant ECG abnormalities: ST Segment
|
28 days
|
Number of Patients With Electrocardiogram (ECG) Abnormalities: T Wave
Tidsramme: 28 days
|
Incidence of potentially clinically significant ECG abnormalities: T wave
|
28 days
|
Number of Patients With Electrocardiogram (ECG) Abnormalities: Right Bundle Branch Block (RBBB), Left Bundle Branch Block (LBBB), Myocardial Infarction (MI)
Tidsramme: 28 days
|
Incidence of potentially clinically significant ECG abnormalities: Right bundle branch block (RBBB), Left bundle branch block (LBBB), myocardial infarction (MI)
|
28 days
|
Number of Patients With Electrocardiogram (ECG) Abnormalities: Arrhythmia
Tidsramme: 28 days
|
Incidence of potentially clinically significant ECG abnormalities: arrhythmia
|
28 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joseph Verbalis, MD, Georgetown University, Washington, DC, 20007 USA
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2007
Primær færdiggørelse (Faktiske)
1. februar 2009
Studieafslutning (Faktiske)
1. marts 2009
Datoer for studieregistrering
Først indsendt
25. oktober 2007
Først indsendt, der opfyldte QC-kriterier
26. oktober 2007
Først opslået (Skøn)
29. oktober 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. april 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. april 2011
Sidst verificeret
1. april 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 156-04-246
- INSIGHT
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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