EUCTR2006-004152-20-DE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). - REFLECT-4
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
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
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).
研究者
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