None listed
Conditions
Interventions
RSG XR Type of group
RSG XR 4mg o.d. during the first 4 weeks, followed by 8mg or.d. for another 48 more weeks.
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female subject who has satisfactorily completed Visit 8 of AVA 105640 without safety or tolerability problems, and those in the opinion of the subject / caregiver and researcher would benefit from receiving RSG XR. • Female subjects able to have children should agree to use an appropriate contraceptive method for the duration of the study (See Section 11.1, Appendix 1 for the details of which highly effective contraceptive methods to use in order to avoid pregnancy). Female subjects who are premenopausal or who have been postmenopausal for less than a year must undergo pregnancy tests (urine test) <7 days before Visit 1, and must be negative • The subject wishes to participate in the extension study and has provided written and complete informed consent before performing any procedure specified by the protocol; or if you are unable to provide informed consent due to your cognitive status, a full written informed consent on behalf of the subject that is provided by a legally acceptable representative (where this is in accordance with local laws, regulations and the policy of the Ethics Committee). • The subject lives with (or has important periods of contact with) a constant caregiver who wishes to participate in all visits, monitor the subject´s compliance with the procedures specified by the protocol and study medication and report on the subject´s general condition . • The subject is able to comply with the procedures for cognitive and other tests. • The caregiver has provided written and complete informed consent on his / her own before performing any procedure specific to the protocol. • Subjects considered for recruitment should have a QTc (either QTc B (Bazett correction) or QTc F (Fridericia correction)) less than 450msec in Visit 1, with the exception of subjects with complete branch block ( for which the QTc B or QTc F should be less than 480 msec). • In France, a subject will be eligible for inclusion in this study only if he or she is a member or beneficiary of a social security category.
Exclusion criteria
Exclusion criteria: • Subjects who have had a serious adverse event or clinically significant laboratory abnormalities during AYA 105640 and which in the opinion of the investigator may have been attributable to the study medication and continue in Visit 1. • The researcher perceives that the subject is not adequate (based on health, compliance, availability of caregiver or any other reason) for inclusion in the study. • Subject has experienced a significant cardiovascular event during AVA105640 (eg, intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non-Q myocardial infarction, Q myocardial infarction, unstable angina] or significant arrhythmia), unless that a deep cardiovascular evaluation has been performed to confirm that the subject does not have congestive heart failure and that he is clinically stable. • Clinical evidence or congestive heart failure tests as defined by criteria (Class I to IV) of the New York Heart Association (NYHA) at the time of Visit 1. • Clinically significant peripheral edema at the time of Visit 1. • Values ​​of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase greater than 2.5 times the upper limit of normal (ULN), total bilirubin values ​​greater than 1.5 times the ULN, or history of severe hepatobiliary disease (eg Hepatitis B or C, cirrhosis, Child-Pugh Class B / C). • The subject is a family member or immediate employee of the participating researcher, or any of the participating team or GSK. • In France, if the subject is not affiliated or is a beneficiary of a social security category. • In France, if the subject has participated in a study that uses a research drug during the last 30 days (except for the participation in AVAL 05640).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:ae: Any adverse medical occurrence in a patient or clinical research subject, temporarily associated with the use of the medicinal product, considered or not related to the medicinal product. Measure:incidence and severity of AEs Timepoints:During treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:A serious adverse event is any adverse medical occurrence that, at any dosage: Result in death, Threatens life, Requires hospitalization or prolongation of an existing hospitalization. Measure:Incidence and severity of SAEs Timepoints:During treatment ; Outcome name:Number of subjects presenting edema Measure:Percentage of subjects with the adverse event of edema Timepoints:During treatment ; Outcome name:Physical examination and vital signs Measure:Change in vital signs with respect to the basal level, Frequency of vital signs of clinical importance, Change in weight with respect to the basal level Timepoints:During the study ; Outcome name:Lipidic profile Measure:Change in the measurements of lipid metabolism with respect to basal with the patient not fasting (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides) Timepoints:During the study | — |
Countries
Austria, Bulgaria, Estonia, Germany, Greece, Hungary, Peru, United Kindgdom
Contacts
Public ContactPamela Mariela Olaechea
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed