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

26. april 2011 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Intervensjonell

Registrering (Faktiske)

57

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Hawthorne, California, Forente stater, 90250
        • Sarah. S. Olelewe, MD
      • Vista, California, Forente stater, 92083
        • Progressive Clinical Research
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80907
        • Pikes Peak Cardiology
    • Florida
      • Largo, Florida, Forente stater, 33770
        • Innovative Research of West FL
      • Punta Gorda, Florida, Forente stater, 33950
        • Coastal Nephrology Assoc. Research Center
    • Georgia
      • Conyers, Georgia, Forente stater, 30094
        • Rockdale Medical Research Associates
    • Louisiana
      • Natchitoches, Louisiana, Forente stater, 71457
        • Otis Barnum, DO
    • North Dakota
      • Fargo, North Dakota, Forente stater, 58106
        • Lillestol Research, LLC
    • South Carolina
      • Columbia, South Carolina, Forente stater, 29201
        • Carolina Research Associates
    • Tennessee
      • Lebanon, Tennessee, Forente stater, 37087
        • Wayne O. Wells, MD
    • Texas
      • Houston, Texas, Forente stater, 77043
        • Memorial Clinical Associates
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • Mitchell Rosner, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: 1
Placebo tablet given once a day for 21 days
Legemiddel: Placebo
Placebo tablet given once daily for 21 days
Aktiv komparator: 2
Tolvaptan 15 mg-60 mg tablet given once a day for 21 days.
Legemiddel: Tolvaptan
15-60 mg oral tablet given once a day for 21 days.
Andre navn:
  • OPC-41061

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
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
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Samarbeidspartnere

Otsuka Pharmaceutical Co., Ltd.

Etterforskere

  • Hovedetterforsker: Joseph Verbalis, MD, Georgetown University, Washington, DC, 20007 USA

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2007

Primær fullføring (Faktiske)

1. februar 2009

Studiet fullført (Faktiske)

1. mars 2009

Datoer for studieregistrering

Først innsendt

25. oktober 2007

Først innsendt som oppfylte QC-kriteriene

26. oktober 2007

Først lagt ut (Anslag)

29. oktober 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. april 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. april 2011

Sist bekreftet

1. april 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 156-04-246
  • INSIGHT

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