Mild-moderate Alzheimer disease MedDRA version: 6.1 Level: PT Classification code 10012271
Conditions
Interventions
Product Name: Rosiglitazone XR
Product Code: BRL-049653
Pharmaceutical Form: Prolonged-release tablet
CAS Number: 155141290
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
GlaxoSmithKline Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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. 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 ;Inclusion 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. 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: 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 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 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 category. 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). ;Exclusion criteria: 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 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 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 category. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed either Study AVA102670 or AVA102672.;Secondary Objective: to explore further the long-term efficacy of RSG XR on cognitive function and overall clinical response in subjects with mild-to-moderate AD who have completed either Study AVA102670 or AVA102672.;Primary end point(s): The primary safety endpoint is the incidence and severity of adverse events (AEs).;Main Objective: to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed either Study AVA102670 or AVA102672.;Secondary Objective: to explore further the long-term efficacy of RSG XR on cognitive function and overall clinical response in subjects with mild-to-moderate AD who have completed either Study AVA102670 or AVA102672.;Primary end point(s): The primary safety endpoint is the incidence and severity of adverse events (AEs). | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Portugal, Slovenia, Spain, Sweden, United Kingdom
Contacts
Public Contact; ;
;
Outcome results
None listed