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临床试验/EUCTR2006-004152-20-AT
EUCTR2006-004152-20-AT进行中（未招募）不适用

An open-label extension study of the long-term safety and efficacy of rosiglitazone extended-release (RSG XR) as adjunctive therapy to acetylcholinesterase inhibitors in subjects with mild-to-moderate Alzheimer's disease (REFLECT-4).

GlaxoSmithKline Research & Development Ltd0 个研究点目标入组 1,500 人开始时间: 2007年9月21日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
1,500
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •Subjects eligible for enrollment in the study must meet all of the following criteria:
  • •1. Male or female subject who has successfully completed Visit 10 of AVA102670 or
  • •AVA102672 without safety/tolerability issues, where in the opinion of the
  • •subject/carer and of the investigator, it would be beneficial to receive RSG XR.
  • •However subjects who have completed of the double-blind treatment phase may still
  • •be eligible for entry if they withdraw during the last 6 weeks of AVA102670 or
  • •AVA102672 due to any reason other than safety (subjects who withdraw from
  • •AVA102670 or AVA102672 due to safety/tolerability issues during the last 6 weeks
  • •of treatment will not be eligible to enter this study).
  • •2. Female subjects able to bear children must agree to use an adequate method of
  • •contraception for the duration of the study (See Appendix 11.1 for details of highly
  • •effective methods to avoid pregnancy). Female subjects who are pre-menopausal or
  • •who have been post-menopausal for <1 year must undertake pregnancy testing (urine test) =7 days before Visit 1, which must be negative1.
  • •3. Subject is willing to participate in the extension study and has provided full written
  • •informed consent prior to the performance of any protocol-specified procedure; or if
  • •unable to provide informed consent due to cognitive status, full written informed
  • •consent on behalf of the subject has been provided by a legally acceptable
  • •representative (where this is in accordance with local laws, regulations and ethics
  • •committee policy).
  • •4. Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to attend all visits, oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status2.
  • •5. Subject has the ability to comply with procedures for cognitive and other testing.
  • •6. Caregiver has provided full written informed consent on his or her own behalf prior
  • •to the performance of any protocol-specified procedure.
  • •7. Subjects considered for enrolment must have a QTc (either QTc B (Bazett's
  • •correction) or QTc F (Fridericia's correction)) <450msec at Visit 1, with the
  • •exception of subjects with bundle branch block (for whom either QTc B or QTc F
  • •must be <480msec)3.
  • •8. In France, a subject will be eligible for inclusion in this study only if either affiliated
  • •to or a beneficiary of a social security category.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range
  • •Subjects eligible for enrollment in the study must meet all of the following criteria:
  • •1. Male or female subject who has successfully completed Visit 10 of AVA102670 or
  • •AVA102672 without safety/tolerability issues, where in the opinion of the
  • •subject/carer and of the investigator, it would be beneficial to receive RSG XR.
  • •However subjects who have completed of the double-blind treatment phase may still
  • •be eligible for entry if they withdraw during the last 6 weeks of AVA102670 or
  • •AVA102672 due to any reason other than safety (subjects who withdraw from
  • •AVA102670 or AVA102672 due to safety/tolerability issues during the last 6 weeks
  • •of treatment will not be eligible to enter this study).
  • •2. Female subjects able to bear children must agree to use an adequate method of
  • •contraception for the duration of the study (See Appendix 11.1 for details of highly
  • •effective methods to avoid pregnancy). Female subjects who are pre-menopausal or
  • •who have been post-menopausal for <1 year must undertake pregnancy testing (urine test) =7 days before Visit 1, which must be negative1.
  • •3. Subject is willing to participate in the extension study and has provided full written
  • •informed consent prior to the performance of any protocol-specified procedure; or if
  • 另有 20 项未显示

排除标准

  • •Subjects meeting any of the following criteria must not be enrolled in the study:
  • •1. Subject had a serious adverse experience or clinically significant laboratory
  • •abnormality during AVA102670 or AVA102672, which in the opinion of the
  • •investigator could have been attributable to study medication, and which is ongoing
  • •at Visit 1.
  • •2. The subject is felt by the investigator to be unsuitable (on the basis of health,
  • •compliance, caregiver availability, or for any other reason) for inclusion in the study.
  • •3. The subject experienced a significant cardiovascular event during AVA102670 or
  • •AVA102672 (e.g. intervention, percutaneous coronary intervention, vascular
  • •surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave
  • •myocardial infarction, unstable angina] or significant arrhythmia), unless a thorough
  • •cardiovascular evaluation has been performed which confirms that the subject does
  • •not have congestive heart failure, and is clinically stable.
  • •4. Clinical/investigational evidence of congestive heart failure defined by the New
  • •York Heart Association (NYHA) criteria (Class I to IV cardiac status) at the time of
  • •5. Clinically significant peripheral oedema at the time of Visit 1.
  • •6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline
  • •phosphatase values >2.5 times the ULN, total bilirubin values >1.5 times the upper
  • •limit of normal (ULN), or history of severe hepatobiliary disease (e.g. hepatitis B or
  • •C, or cirrhosis, Child-Pugh Class B/C).
  • •In Canada only, the following change will be made to Exclusion Criteria number 6.
  • •ALT, AST, or alkaline phosphatase values >2.0 times the ULN, total bilirubin values
  • •>1.5 times the ULN, or history of severe hepatobiliary disease (e.g. hepatitis B or C,
  • •or cirrhosis, Child-Pugh Class B/C).
  • •7. Subject is an immediate family member or employee of the participating
  • •Investigator, of any of the participating site staff, or of GSK.
  • •8. In France, a subject is neither affiliated with nor a beneficiary of a social security
  • •9. In France, a subject has participated in any study using an investigational drug
  • •during the previous 30 days (except for participation in AVA102670 or
  • •AVA102672).
  • •Subjects meeting any of the following criteria must not be enrolled in the study:
  • •1. Subject had a serious adverse experience or clinically significant laboratory
  • •abnormality during AVA102670 or AVA102672, which in the opinion of the
  • •investigator could have been attributable to study medication, and which is ongoing
  • •at Visit 1.
  • •2. The subject is felt by the investigator to be unsuitable (on the basis of health,
  • •compliance, caregiver availability, or for any other reason) for inclusion in the study.
  • •3. The subject experienced a significant cardiovascular event during AVA102670 or
  • •AVA102672 (e.g. intervention, percutaneous coronary intervention, vascular
  • •surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave
  • •myocardial infarction, unstable angina] or significant arrhythmia), unless a thorough
  • •cardiovascular evaluation has been performed which confirms that the subject does
  • •not have congestive heart failure, and is clinically stable.
  • •4. Clinical/investigational evidence of congestive heart failure defined by the New
  • •York Heart Association (NYHA) criteria (Class I to IV cardiac status) at the time of
  • •5. Clinically significant peripheral oedema at the time of Visit 1.
  • •6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline
  • •phosphatase values >2.5 times the ULN, total bilirubin values >1.5 times the upper
  • •limit of normal (ULN), or history of severe hepatobiliary disease (e.g. hepatitis B or
  • •C, or cirrhosis, Child-Pugh Class B/C).
  • 另有 10 项未显示

研究者

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