Last updated: 11/04/2018 05:15:19
Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease
Trial description: This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with adverse events (AE's)
Timeframe: From start of study medication (Wk 0) to Wk 50
Secondary outcomes:
Mean change from baseline in Mini Mental State Examination (MMSE) total score
Timeframe: From baseline to Wk 48
Number of participants with SAEs
Timeframe: From start of study medication (Wk 0) to Wk 50
Number of participants with AE of peripheral edema by grade
Timeframe: Up to Wk 50
Mean change from baseline in vital signs- systolic and diastolic blood pressure
Timeframe: Baseline (Wk 0) to Wk 50
Mean change from baseline in vital signs-heart rate (HR)
Timeframe: Baseline (Wk 0) to Wk 50
Number of participants with vital signs of clinical concern.
Timeframe: Up to Wk 50
Mean change from baseline in vital signs- weight
Timeframe: Baseline (Wk 0) to Wk 50
Number of participants with clinical chemistry parameters of clinical concern
Timeframe: Up to Wk 50
Number of participants with clinical chemistry parameters of clinical concern-lipids
Timeframe: Up to Wk 50
Number of participant's with hematology parameters of clinical concern
Timeframe: Up to Wk 50
Interventions:
Drug: rosiglitazone
Enrollment:
33
Observational study model:
Not applicable
Primary completion date:
2009-03-02
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Alzheimer's Disease
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
June 2006 to February 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
50 - 85 years
Accepts healthy volunteers
No
- Male or female subject who has successfully completed the 12 Month Visit of 49653/461 (12 months of treatment) without tolerability issues, where in the opinion of the subject and of the investigator, it will be beneficial to continue treatment with RSG XR.
- Female subjects must be post-menopausal (i.e. >6 months without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD) a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures throughout the study and for 30 days after discontinuing study medication. The subject and their caregiver must ensure that the subject will continuously use contraceptive measures throughout the duration of the study.
- Subject had a serious adverse experience (SAE) or clinically significant laboratory abnormality during 49653/461, which in the opinion of the investigator could have been attributable to study medication, and which is ongoing at the end of 49653/461.
- 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 based on the entry criteria for the primary study, 49653/461 (exclusive of the age criteria which may not be applicable to some of the subjects).
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female subject who has successfully completed the 12 Month Visit of 49653/461 (12 months of treatment) without tolerability issues, where in the opinion of the subject and of the investigator, it will be beneficial to continue treatment with RSG XR.
- Female subjects must be post-menopausal (i.e. >6 months without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD) a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures throughout the study and for 30 days after discontinuing study medication. The subject and their caregiver must ensure that the subject will continuously use contraceptive measures throughout the duration of the study.
- 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[1].[1] Where this is in accordance with local laws, regulations and ethics committee policy.
- Caregiver has provided full written informed consent on his or her own behalf prior to the performance of any protocol-specified procedure.
Exclusion criteria:
- Subject had a serious adverse experience (SAE) or clinically significant laboratory abnormality during 49653/461, which in the opinion of the investigator could have been attributable to study medication, and which is ongoing at the end of 49653/461.
- 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 based on the entry criteria for the primary study, 49653/461 (exclusive of the age criteria which may not be applicable to some of the subjects).
- The subject experienced a significant cardiovascular event during 49653/461 (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.
- Treatment with a cholinesterase inhibitor, selegiline, memantine or any other treatment for cognitive symptoms/AD is initiated at the end of 49653/461.
Trial location(s)
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Status
Study Complete
Location
GSK Investigational Site
Litchfield Park, Arizona, United States, 85340
Status
Study Complete
Location
GSK Investigational Site
Sun City, Arizona, United States, 85351
Status
Study Complete
Location
GSK Investigational Site
Belmont, Massachusetts, United States, 02478
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85006
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27705
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-03-02
Actual study completion date
2009-03-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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