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- Ensaio Clínico NCT00748566
One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome
2 de março de 2021 atualizado 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.
Visão geral do estudo
Status
Rescindido
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
172
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alberta
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Calgary, Alberta, Canadá, T2N 2T9
- Pfizer Investigational Site
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Calgary, Alberta, Canadá, T2N 4Z6
- Pfizer Investigational Site
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Medicine Hat, Alberta, Canadá, T1B 4E7
- Pfizer Investigational Site
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Medicine Hat, Alberta, Canadá, T1A 4C2
- Pfizer Investigational Site
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Red Deer, Alberta, Canadá, T4N 1T6
- Pfizer Investigational Site
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British Columbia
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Penticton, British Columbia, Canadá, V2A 4M4
- Pfizer Investigational Site
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Victoria, British Columbia, Canadá, V8R 4Z3
- Pfizer Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canadá, R3A 1R9
- Pfizer Investigational Site
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Winnipeg, Manitoba, Canadá, R3E 3N4
- Pfizer Investigational Site
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Winnipeg, Manitoba, Canadá, R3K 2E2
- Pfizer Investigational Site
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Winnipeg, Manitoba, Canadá, R3P 0N5
- Pfizer Investigational Site
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New Brunswick
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Bathurst, New Brunswick, Canadá, E2A 2Z6
- Pfizer Investigational Site
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canadá, A1E 4J8
- Pfizer Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 2E2
- Pfizer Investigational Site
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Sydney, Nova Scotia, Canadá, B1P 1C6
- Pfizer Investigational Site
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Sydney, Nova Scotia, Canadá, B1P 1E1
- Pfizer Investigational Site
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Ontario
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Burlington, Ontario, Canadá, L7R 4E2
- Pfizer Investigational Site
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Chatham, Ontario, Canadá, N7L 1B7
- Pfizer Investigational Site
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Kingston, Ontario, Canadá, K7L 4X3
- Pfizer Investigational Site
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London, Ontario, Canadá, N6A 4G5
- Pfizer Investigational Site
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Markham, Ontario, Canadá, L6B 1A1
- Pfizer Investigational Site
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Mississauga, Ontario, Canadá, L5M 4N4
- Pfizer Investigational Site
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Ottawa, Ontario, Canadá, K1H 8K7
- Pfizer Investigational Site
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Sudbury, Ontario, Canadá, P3E 1X3
- Pfizer Investigational Site
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Toronto, Ontario, Canadá, M5T 1R8
- Pfizer Investigational Site
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Toronto, Ontario, Canadá, M6J 1H4
- Pfizer Investigational Site
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Windsor, Ontario, Canadá, N9C 3Z4
- Pfizer Investigational Site
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Quebec
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Montreal, Quebec, Canadá, H3A 1A1
- Pfizer Investigational Site
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Montreal, Quebec, Canadá, H1N 3M5
- Pfizer Investigational Site
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Montreal, Quebec, Canadá, H1N 3V2
- Pfizer Investigational Site
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Verdun, Quebec, Canadá, H4H 1R3
- Pfizer Investigational Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7K 3H3
- Pfizer Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Active treatment (switch to oral Ziprasidone)
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Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40 to 160 mg total daily dose) for up to 1 year.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)
Prazo: Endpoint (premature discontinuation or Week 52)
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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.
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Endpoint (premature discontinuation or Week 52)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52
Prazo: Baseline, Week 4, 12, 28, 52
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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.
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Baseline, Week 4, 12, 28, 52
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Percentage of Participants With Metabolic Syndrome (MS)
Prazo: Baseline, Week 4, 12, 28, 52
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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.
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Baseline, Week 4, 12, 28, 52
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Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52
Prazo: Week 4, 12, 28, 52
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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.
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Week 4, 12, 28, 52
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Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)
Prazo: Baseline, Week 4, 12, 28, 52
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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.
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Baseline, Week 4, 12, 28, 52
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Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52
Prazo: Baseline, Week 4, 12, 28, 52
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Waist circumference data is reported separately for male and female participants.
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Baseline, Week 4, 12, 28, 52
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Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52
Prazo: Baseline, Week 4, 12, 28, 52
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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).
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Baseline, Week 4, 12, 28, 52
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Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52
Prazo: Baseline, Week 4, 12, 28, 52
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Triglyceride data is reported for whole study population whereas HDL-C data is reported separately for male and female participants.
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Baseline, Week 4, 12, 28, 52
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Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52
Prazo: Baseline, Week 4, 12, 28, 52
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Baseline, Week 4, 12, 28, 52
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Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52
Prazo: Baseline, Week 4, 12, 28, 52
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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.
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Baseline, Week 4, 12, 28, 52
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Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52
Prazo: Baseline, Week 4, 12, 28, 52
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Baseline, Week 4, 12, 28, 52
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Change From Baseline in Weight at Week 4,12, 28 and 52
Prazo: Baseline, Week 4, 12, 28, 52
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Baseline, Week 4, 12, 28, 52
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Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52
Prazo: Baseline, Week 4, 12, 28, 52
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Body mass index calculated as weight in kilograms (kg) divided by height in (meters) squared (m)^2 .
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Baseline, Week 4, 12, 28, 52
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Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52
Prazo: Baseline, Week 4, 12, 28, 52
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HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
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Baseline, Week 4, 12, 28, 52
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Change From Baseline in Insulin Level at Week 4, 12, 28 and 52
Prazo: Baseline, Week 4, 12, 28, 52
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Baseline, Week 4, 12, 28, 52
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Change From Baseline in the Physical Activity Index Score at Week 28 and 52
Prazo: Baseline, Week 28, 52
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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.
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Baseline, Week 28, 52
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Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52
Prazo: Baseline, Week 4, 12, 28, 52
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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).
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Baseline, Week 4, 12, 28, 52
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52
Prazo: Baseline, Week 12, 28, 52
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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.
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Baseline, Week 12, 28, 52
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Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52
Prazo: Baseline, Week 12, 28, 52
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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).
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Baseline, Week 12, 28, 52
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Clinical Global Impression-Improvement (CGI-I) Scale Score
Prazo: Endpoint (premature discontinuation or Week 52)
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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.
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Endpoint (premature discontinuation or Week 52)
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Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52
Prazo: Baseline, Week 28, 52
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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.
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Baseline, Week 28, 52
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Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52
Prazo: Baseline, Week 28, 52
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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.
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Baseline, Week 28, 52
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Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52
Prazo: Baseline, Week 28, 52
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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.
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Baseline, Week 28, 52
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Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52
Prazo: Baseline, Week 28, 52
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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.
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Baseline, Week 28, 52
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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
Prazo: Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52
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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").
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Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2008
Conclusão Primária (Real)
1 de maio de 2012
Conclusão do estudo (Real)
1 de maio de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
5 de setembro de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de setembro de 2008
Primeira postagem (Estimativa)
8 de setembro de 2008
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de março de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de março de 2021
Última verificação
1 de março de 2021
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Resistência a insulina
- Hiperinsulinismo
- Esquizofrenia
- Transtornos Psicóticos
- Síndrome metabólica
- Transtornos Mentais, Desordem Mental
- Espectro da Esquizofrenia e Outros Transtornos Psicóticos
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Depressores do Sistema Nervoso Central
- Antipsicóticos
- Agentes Tranquilizantes
- Drogas Psicotrópicas
- Agentes de Serotonina
- Agentes de Dopamina
- Antagonistas da Serotonina
- Antagonistas da Dopamina
- Ziprasidona
Outros números de identificação do estudo
- A1281173
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Ziprasidone HCL (oral)
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Helsinn Healthcare SAConcluídoCâncer de Pulmão de Células Não Pequenas | Caquexia; CâncerEstados Unidos, Croácia, Austrália, Bélgica, Federação Russa, Polônia, Romênia, Ucrânia
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National Cancer Institute (NCI)DesconhecidoCâncer de Cabeça e Pescoço | Toxicidade de radiação | Complicações orais da radioterapiaEstados Unidos
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Arvid Carlsson Research ABGottfries Clinic ABConcluído
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Amicus TherapeuticsConcluído
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State University of New York at BuffaloAinda não está recrutando
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University of Kansas Medical CenterNational Cancer Institute (NCI)ConcluídoCâncer de mamaEstados Unidos
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Assiut UniversityDesconhecidoRefluxo gastroesofágico | Refluxo gastrico
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BioCryst PharmaceuticalsConcluídoLeucemia Linfocítica Crônica (LLC)Estados Unidos, Austrália
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PfizerConcluídoOsteoartrite do JoelhoEstados Unidos