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One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome

2 marca 2021 zaktualizowane przez: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A One-Year, Phase IV, Open-Label, Non-Comparative Trial Of The Effect Of Ziprasidone HCL On Metabolic Syndrome Risk Factors In Patients With Psychotic Disorders

The purpose of this study is to explore the impact of ziprasidone on the distribution of metabolic syndrome risk factors in a population of patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

The trial was terminated prematurely on May 24, 2012, due to changes in organizational strategy and resources. The decision to terminate the trial was not based on any safety or efficacy concerns.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

172

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 2T9
        • Pfizer Investigational Site
      • Calgary, Alberta, Kanada, T2N 4Z6
        • Pfizer Investigational Site
      • Medicine Hat, Alberta, Kanada, T1B 4E7
        • Pfizer Investigational Site
      • Medicine Hat, Alberta, Kanada, T1A 4C2
        • Pfizer Investigational Site
      • Red Deer, Alberta, Kanada, T4N 1T6
        • Pfizer Investigational Site
    • British Columbia
      • Penticton, British Columbia, Kanada, V2A 4M4
        • Pfizer Investigational Site
      • Victoria, British Columbia, Kanada, V8R 4Z3
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R3A 1R9
        • Pfizer Investigational Site
      • Winnipeg, Manitoba, Kanada, R3E 3N4
        • Pfizer Investigational Site
      • Winnipeg, Manitoba, Kanada, R3K 2E2
        • Pfizer Investigational Site
      • Winnipeg, Manitoba, Kanada, R3P 0N5
        • Pfizer Investigational Site
    • New Brunswick
      • Bathurst, New Brunswick, Kanada, E2A 2Z6
        • Pfizer Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Kanada, A1E 4J8
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada, B3H 2E2
        • Pfizer Investigational Site
      • Sydney, Nova Scotia, Kanada, B1P 1C6
        • Pfizer Investigational Site
      • Sydney, Nova Scotia, Kanada, B1P 1E1
        • Pfizer Investigational Site
    • Ontario
      • Burlington, Ontario, Kanada, L7R 4E2
        • Pfizer Investigational Site
      • Chatham, Ontario, Kanada, N7L 1B7
        • Pfizer Investigational Site
      • Kingston, Ontario, Kanada, K7L 4X3
        • Pfizer Investigational Site
      • London, Ontario, Kanada, N6A 4G5
        • Pfizer Investigational Site
      • Markham, Ontario, Kanada, L6B 1A1
        • Pfizer Investigational Site
      • Mississauga, Ontario, Kanada, L5M 4N4
        • Pfizer Investigational Site
      • Ottawa, Ontario, Kanada, K1H 8K7
        • Pfizer Investigational Site
      • Sudbury, Ontario, Kanada, P3E 1X3
        • Pfizer Investigational Site
      • Toronto, Ontario, Kanada, M5T 1R8
        • Pfizer Investigational Site
      • Toronto, Ontario, Kanada, M6J 1H4
        • Pfizer Investigational Site
      • Windsor, Ontario, Kanada, N9C 3Z4
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Kanada, H3A 1A1
        • Pfizer Investigational Site
      • Montreal, Quebec, Kanada, H1N 3M5
        • Pfizer Investigational Site
      • Montreal, Quebec, Kanada, H1N 3V2
        • Pfizer Investigational Site
      • Verdun, Quebec, Kanada, H4H 1R3
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada, S7K 3H3
        • Pfizer Investigational Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Subject must present at least 2 of the following risk factors of MS at screening: Elevated waist circumference: >102 cm in men and >88 cm in women; Elevated triglycerides (TGs): ≥1.7 mmol/L (≥150 mg/dL); Reduced HDL-Cholesterol: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; Elevated fasting glucose: ≥ 5.6 mmol/L.
  • According to the clinical judgment of the investigator, the risk factors for MS have developed in close temporal relationship to starting an antipsychotic medication.
  • Substitution to a less metabolically disruptive antipsychotic medication is considered.

Exclusion Criteria:

  • Subjects with contraindication(s) to the use of Ziprasidone according to Canadian prescribing information.
  • Subjects with a history of treatment resistance.
  • Subjects with any medical condition (e.g. pre-existing diabetes, pre-existing dyslipidemia, thyroid pathology) or taking any concomitant medication (e.g. topiramate or other weight loss-promoting agents, hypoglycemic agents, hypolipemic agents), that may confound the evaluation of the study drug.
  • Body mass index ≥ 40 at baseline.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Active treatment (switch to oral Ziprasidone)
Lek: Ziprasidone HCL (oral)
Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40 to 160 mg total daily dose) for up to 1 year.
Inne nazwy:
  • Zeldox, Geodon

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)
Ramy czasowe: Endpoint (premature discontinuation or Week 52)
MS risks factors: elevated (el) waist, men:>=102 centimeters(cm), women:>=88 cm (Asian origin:>=90 cm in men, >=80 cm in women); el triglycerides: >=1.7 millimoles per liter (mmol/L) (>=150 milligram per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C), men:<1.03 mmol/L (<40 mg/dL), women:<1.3 mmol/L (<50 mg/dL); el fasting glucose: >=5.6 mmol/L (>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP>=130 millimeters of mercury (mmHg) and/or DBP>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline.
Endpoint (premature discontinuation or Week 52)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52
Ramy czasowe: Baseline, Week 4, 12, 28, 52
MS risks factors: elevated waist circumference: greater than or equal to (>=)102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): less than (<)1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.
Baseline, Week 4, 12, 28, 52
Percentage of Participants With Metabolic Syndrome (MS)
Ramy czasowe: Baseline, Week 4, 12, 28, 52
According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATPIII), metabolic syndrome is defined as a condition that includes 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.
Baseline, Week 4, 12, 28, 52
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52
Ramy czasowe: Week 4, 12, 28, 52
MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.
Week 4, 12, 28, 52
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)
Ramy czasowe: Baseline, Week 4, 12, 28, 52
MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.
Baseline, Week 4, 12, 28, 52
Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52
Ramy czasowe: Baseline, Week 4, 12, 28, 52
Waist circumference data is reported separately for male and female participants.
Baseline, Week 4, 12, 28, 52
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52
Ramy czasowe: Baseline, Week 4, 12, 28, 52
BP measurement is recorded as systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).
Baseline, Week 4, 12, 28, 52
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52
Ramy czasowe: Baseline, Week 4, 12, 28, 52
Triglyceride data is reported for whole study population whereas HDL-C data is reported separately for male and female participants.
Baseline, Week 4, 12, 28, 52
Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52
Ramy czasowe: Baseline, Week 4, 12, 28, 52
Baseline, Week 4, 12, 28, 52
Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52
Ramy czasowe: Baseline, Week 4, 12, 28, 52
Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to >=25, higher score indicates higher CHD risk. The risk points are transformed to 10-year risk percentage for CHD which ranges from <1% to >=30%, where higher percent indicates greater risk for CHD.
Baseline, Week 4, 12, 28, 52
Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52
Ramy czasowe: Baseline, Week 4, 12, 28, 52
Baseline, Week 4, 12, 28, 52
Change From Baseline in Weight at Week 4,12, 28 and 52
Ramy czasowe: Baseline, Week 4, 12, 28, 52
Baseline, Week 4, 12, 28, 52
Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52
Ramy czasowe: Baseline, Week 4, 12, 28, 52
Body mass index calculated as weight in kilograms (kg) divided by height in (meters) squared (m)^2 .
Baseline, Week 4, 12, 28, 52
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52
Ramy czasowe: Baseline, Week 4, 12, 28, 52
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Baseline, Week 4, 12, 28, 52
Change From Baseline in Insulin Level at Week 4, 12, 28 and 52
Ramy czasowe: Baseline, Week 4, 12, 28, 52
Baseline, Week 4, 12, 28, 52
Change From Baseline in the Physical Activity Index Score at Week 28 and 52
Ramy czasowe: Baseline, Week 28, 52
Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (>=21). Higher total score = higher frequency and intensity of physical activity.
Baseline, Week 28, 52
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52
Ramy czasowe: Baseline, Week 4, 12, 28, 52
QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds (60 divided by heart rate).
Baseline, Week 4, 12, 28, 52
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52
Ramy czasowe: Baseline, Week 12, 28, 52
Assesses positive and negative symptoms, general psychopathology specifically associated with schizophrenia. Scale consists of 30 items, each rated on scale from 1 (symptom not present) - 7 (symptoms extremely severe). Sum of 30 items is defined as PANSS total score, range:30-210. 7 items make up positive scale (delusions, conceptual disorganization, hallucinatory behavior); total range: 7-49. 7 items make up negative scale (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); total range: 7-49. For each subscale, total score: higher score=greater severity.
Baseline, Week 12, 28, 52
Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52
Ramy czasowe: Baseline, Week 12, 28, 52
CGI-S is a single-item, clinician-rated scale that assesses the global severity of the participants overall illness. CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill participants).
Baseline, Week 12, 28, 52
Clinical Global Impression-Improvement (CGI-I) Scale Score
Ramy czasowe: Endpoint (premature discontinuation or Week 52)
CGI-I is a single-item, clinician-rated scale that assesses global improvement in the participants clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 to 7, where 1=very much improved, 4=no change and 7=very much worse.
Endpoint (premature discontinuation or Week 52)
Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52
Ramy czasowe: Baseline, Week 28, 52
DAI, a 30-item scale measuring subjective responses to medication (including acceptability and tolerability which aims to understand the factors influencing treatment adherence). Scale has 15 items (statements) scored as true and 15 items scored as false. An overall calculated score ranged from -15 to 15, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance.
Baseline, Week 28, 52
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52
Ramy czasowe: Baseline, Week 28, 52
SOFAS: a 0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning.
Baseline, Week 28, 52
Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52
Ramy czasowe: Baseline, Week 28, 52
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Baseline, Week 28, 52
Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52
Ramy czasowe: Baseline, Week 28, 52
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Baseline, Week 28, 52
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52
Ramy czasowe: Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52
C-SSRS assessed whether participant experienced following: completed suicide(1), suicide attempt(2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior(3)("Yes" on "preparatory acts or behavior"), suicidal ideation(4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior(7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 grudnia 2008

Zakończenie podstawowe (Rzeczywisty)

1 maja 2012

Ukończenie studiów (Rzeczywisty)

1 maja 2012

Daty rejestracji na studia

Pierwszy przesłany

5 września 2008

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 września 2008

Pierwszy wysłany (Oszacować)

8 września 2008

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 marca 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 marca 2021

Ostatnia weryfikacja

1 marca 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • A1281173

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Ziprasidone HCL (oral)

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Warunki medyczne

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CROs in Ireland

Warunki

Rzadkie choroby

Interwencje lekowe

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Sponsor / Współpracownicy

Lokalizacje

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