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

2021年3月2日 更新者：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.

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

172

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Active treatment (switch to oral Ziprasidone)
薬：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.
他の名前：
  • ゼルドックス、ジオドン

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, Week 4, 12, 28, 52
Baseline, Week 4, 12, 28, 52
Change From Baseline in Weight at Week 4,12, 28 and 52
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

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

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2008年12月1日

一次修了 (実際)

2012年5月1日

研究の完了 (実際)

2012年5月1日

試験登録日

最初に提出

2008年9月5日

QC基準を満たした最初の提出物

2008年9月5日

最初の投稿 (見積もり)

2008年9月8日

学習記録の更新

投稿された最後の更新 (実際)

2021年3月3日

QC基準を満たした最後の更新が送信されました

2021年3月2日

最終確認日

2021年3月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • A1281173

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Ziprasidone HCL (oral)の臨床試験

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条件

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スポンサー/協力者

場所

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