Mild to Moderate Alzheimer's Disease MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease
Conditions
Interventions
Product Name: Rosiglitazone XR
Product Code: BRL-049653
Pharmaceutical Form: Tablet
INN or Proposed INN: Rosiglitazone
CAS Number: 155141290
Current Sponsor code: BRL-049653
Concentration unit: mg mil
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject eligibility is provided in the RSG XR CIB [GlaxoSmithKline Document Number RM2004/0084/02, 2006], and AVANDIA approved product label. Subjects eligible for enrollment in the study must meet all of the following criteria: 1. Male or female subject who has successfully completed Visit 8 of AVA105640 without safety/tolerability issues, where in the opinion of the subject /carer and of the investigator, it would be beneficial to receive RSG XR. 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 AVA105640, 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 AVA105640 (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 Visit 1. 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 upper limit of normal (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 category. 9. In France, a subject has participated in any study using an investigational drug during the previous 30 days (except for participation in AVA105640).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed Study AVA105640.;Secondary Objective: The secondary objective of this study is to explore further the long-term efficacy of RSG XR on cognitive function and overall clinical response in subjects with mild-tomoderate AD who have completed Study AVA105640.;Primary end point(s): The primary safety endpoint is the incidence and severity of AEs. | — |
Countries
Austria, Bulgaria, Estonia, Germany, Greece, Hungary, United Kingdom
Outcome results
None listed