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

2 de marzo de 2021 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

172

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Active treatment (switch to oral Ziprasidone)
Droga: 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.
Otros nombres:
  • Zeldox, Geodón

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline, Week 4, 12, 28, 52
Baseline, Week 4, 12, 28, 52
Change From Baseline in Weight at Week 4,12, 28 and 52
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de diciembre de 2008

Finalización primaria (Actual)

1 de mayo de 2012

Finalización del estudio (Actual)

1 de mayo de 2012

Fechas de registro del estudio

Enviado por primera vez

5 de septiembre de 2008

Primero enviado que cumplió con los criterios de control de calidad

5 de septiembre de 2008

Publicado por primera vez (Estimar)

8 de septiembre de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de marzo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

2 de marzo de 2021

Última verificación

1 de marzo de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A1281173

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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