Last updated: 11/04/2018 05:11:28
Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy In Subjects With Mild To Moderate Alzheimer’s DiseaseREFLECT-3
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 54 week, double-blind, randomised, placebo-controlled, parallel group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to acetylcholinesterase inhibitors on cognition and overall clinical response in APOE4-stratified subjects with mild to moderate Alzheimer's disease
Trial description: Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG.This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer’s disease (AD) when combined with one of the currently approved AD medications, Aricept®, Razadyne® or Exelon®. RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one’s genetic makeup affects the response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in Alzheimer's Disease Assessment Scale – cognitive subscale (ADAS-Cog) total score at Week 48, as a function of APOE ε4 status in APOE4 negatives cohort
Timeframe: Baseline (Week 0) and Week 48
Change from Baseline in ADAS-Cog total score at Week 48, as a function of APOE ε4 status in All except E4/E4s cohort
Timeframe: Baseline (Week 0) and Week 48
Change from Baseline in ADAS-Cog total score at Week 48, as a function of APOE ε4 status in Full population cohort
Timeframe: Baseline (Week 0) and Week 48
Change from Baseline in Clinical Dementia Rating scale - Sum of Boxes (CDR-SB) score at Week 48, as a function of APOE ε4 status in APOE4 negatives cohort
Timeframe: Baseline (Week 0) and Week 48
Change from Baseline in CDR-SB score at Week 48, as a function of APOE ε4 status in All except E4/E4s cohort
Timeframe: Baseline (Week 0) and Week 48
Change from Baseline in CDR-SB score at Week 48, as a function of APOE ε4 status in Full population cohort
Timeframe: Baseline (Week 0) and Week 48
Secondary outcomes:
Change from Baseline in ADAS-Cog total score at Weeks 8, 16, 24 and 36
Timeframe: Baseline (Week 0) and Week 8, 16, 24, 36
Change from Baseline in CDR-SB score at Weeks 12, 24 and 36
Timeframe: Baseline (Week 0) and Week 12, 24, 36
Change from screening in Mini Mental State Examination (MMSE) total score
Timeframe: Screening (Week -4) and Week 48
Change from Baseline in Disability Assessment for Dementia (DAD) total score
Timeframe: Baseline (Week 0) and Week 8, 16, 24, 48
Change from Baseline in Neuropsychiatric Inventory (NPI) total score
Timeframe: Baseline (Week 0) and Week 8, 16, 24, 48
Change from Baseline in domains of the Resource Utilization in Dementia scale (RUD)- Q1 and Q2 Caregiver Hours
Timeframe: Baseline (Week 0) and Week 12, 24, 36, 48
Change from Baseline in European Quality of Life -5 Dimensions (EQ-5D) scale total score- Thermometer score
Timeframe: Baseline (Week 0) and Week 12, 36, 48
Change from Baseline in EQ-5D scale total score- Utility score
Timeframe: Baseline (Week 0) and Week 12, 36, 48
Change from Baseline in Alzheimer’s Carer’s Quality of Life Instrument (ACQLI) score
Timeframe: Baseline (Week 0) and Week 12, 36, 48
Change in ADAS-Cog total score for observed cases at Week 54 compared to Week 48
Timeframe: Week 48 and Week 54
Change in CDR-SB total score for observed cases at Week 54 compared to Week 48
Timeframe: Week 48 and Week 54
Change from Baseline in Glycosylated hemoglobin (HbA1c) at Week 48
Timeframe: Baseline (Week 0) and Week 48
Number of participants with on-treatment adverse events (AEs), serious adverse events (SAEs) and severity of AEs
Timeframe: Upto Week 48
Number of participants with change from Baseline in vital signs of clinical concern at any time on treatment- Weight
Timeframe: Upto Week 54
Number of participants with change from Baseline in vital signs of clinical concern at any time on treatment- Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
Timeframe: Upto Week 54
Number of participants with change from Baseline in vital signs of clinical concern at any time on treatment- Heart Rate (HR)
Timeframe: Upto Week 54
Change from Baseline in weight
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 16, 24, 36, 48, 54
Change from Baseline in hemoglobin
Timeframe: Baseline (Week 0) and Weeks 4, 16, 36, 48
Change from Baseline in hematocrit
Timeframe: Baseline (Week 0) and Weeks 4, 16, 36, 48
Any time on treatment differences in frequencies of hematology data outside the reference range
Timeframe: Up to Week 48
Any time on treatment differences in frequencies of clinical chemistry data outside the reference range
Timeframe: Upto Week 48
Changes from Baseline in electrocardiogram (ECG) parameters- HR
Timeframe: Baseline (Week 0) and Weeks 4, 8, 16, 24, 36, 48, 54
Changes from Baseline in ECG parameters- RR Interval, QT Interval, QTcB, QTcF, PR Interval and QRS Duration
Timeframe: Baseline (Week 0) and Weeks 4, 8, 16, 24, 36, 48, 54
Change from Baseline in HbA1c up to Week 54
Timeframe: Baseline (Week 0) and Weeks 12, 24, 36, 48, 54
Change from Baseline in short term memory assessment
Timeframe: Baseline (Week 0) and upto Week 48
Interventions:
Drug: Rosiglitazone Extended Release 2mg
Drug: Rosiglitazone Extended Release 8mg
Other: Placebo
Enrollment:
1468
Observational study model:
Not applicable
Primary completion date:
2009-20-03
Time perspective:
Not applicable
Clinical publications:
Conn Harrington, Sharon Sawchak, Carl Chiang, John Davies, Carly Donovan, Ann Saunders, Michael Irrizary, Barbara Jeter, Marina Zvartau-Hind, Christopher van Dyke, Michael Gold. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: Two phase 3 studies. [Curr Alzheimer Res]. 2011;8(5):592-584.
Conn Harrington, Sharon Sawchak, Carl Chiang, John Davies, Carly Donovan, Ann Saunders, Michael Irrizary, Barbara Jeter, Marina Zvartau-Hind, Christopher van Dyke, Michael Gold. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: Two phase 3 studies. Curr Alzheimer Res. 2011;8(5):592-584.
Medical condition
Alzheimer's Disease
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
July 2006 to March 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
50 - 90 years
Accepts healthy volunteers
No
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Male or female subject with a clinical diagnosis of probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria (Appendix 2).
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Diagnosis of possible, probable, or definite vascular dementia in accordance with NINDS-AIREN criteria (Appendix 5).
Inclusion and exclusion criteria
Inclusion criteria:
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Male or female subject with a clinical diagnosis of probable Alzheimer's disease in accordance with NINCDS-ADRDA criteria (Appendix 2). (Note: National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA).)
- Subject has mild to moderate Alzheimer's disease as defined by a MMSE score 10 to 26 inclusive at Screening.
- Hachinski Ischemia Score ≤ 4 at Screening (See Appendix 3).
- Age ≥50 and ≤90 years.
- At least 6 months of ongoing acetylcholinesterase inhibitor therapy for Alzheimer's disease, with stable dosing for at least the last 2 months (and with no intent to change for the duration of the study).
- Current use of medication is in accordance with the criteria listed in Table 2 (Permitted Medications, Section 8.1).
- Female subjects must be post-menopausal (i.e. >1 year without menstrual period), surgically sterile, or agree to use adequate method of contraception (Appendix 4) for the duration of the study. Female subjects who are pre-menopausal or who have been post-menopausal for <1 year must undertake pregnancy testing (urine test) at Visit 1, which must be negative.
- Brain CT or MRI scan performed within the past 12 months or at Screening, showing no evidence of any other potential cause of dementia other than Alzheimer's disease. (Note: Questionable CT or MRI scans should be discussed with the medical monitor, using central imaging guidelines.)
- Neurological exam without focal changes (excluding changes attributable to AD or peripheral trauma).
- Subject has the ability to comply with procedures for cognitive and other testing.
- 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 status. (Note: A non-cohabiting caregiver must spend sufficient time with the subject so that, in the opinion of the Investigator, the caregiver can reliably assess cognitive function, activities and behavior, and report on the subject's compliance and health. As caregiver time spent with a potential subject is anticipated to be highly variable across countries and cultures, GSK will consider a variety of different measures by which this stipulation may be met, and GSK should be consulted if adequacy of a caregiver situation is in doubt. However, as guidance, the ability for a caregiver to meet his/her expected responsibilities for this study would normally be possible when the caregiver spends no less than 10 hours per week with the subject, divided over multiple days.)
- Subject 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. (Note: Consent by legally acceptable representative is allowed where this is in accordance with local laws, regulations and ethics committee policy.)
- Caregiver has provided full written informed consent on his/her own behalf prior to the performance of any protocol-specified procedure.
- 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). (Note: For the purposes of these criteria, QTc B is defined as (QT interval [msec]) / (square root of RR interval [seconds]); and QTc F is defined as (QT interval [msec]) / (cube root of RR interval [seconds]).)
Exclusion criteria:
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Diagnosis of possible, probable, or definite vascular dementia in accordance with NINDS-AIREN criteria (Appendix 5). (Note: National Institute of Neurological Disorders and Stroke (NINDS) and Association Internationale pour la Recherche et l'Enseignement en Neurosciences (AIREN).)
- History or evidence of any other CNS disorder that could be interpreted as a cause of dementia: e.g. cerebrovascular disease (stroke, hemorrhage), structural abnormality, epilepsy, infectious or inflammatory/demyelinating CNS conditions, Parkinson's disease.
- Evidence of the following disorders: current vitamin B12 deficiency, positive syphilis serology, or active thyroid dysfunction (particularly that suggestive of hypothyroidism), including abnormally high or low serum levels of thyroid stimulating hormone (TSH), that are clinically significant in the opinion of the investigator. (Note: Testing is required for each parameter only when no result is available from previous 12 months.)
- History of Type 1 diabetes mellitus or secondary diabetes mellitus.
- Type 2 diabetes mellitus where the subject is being treated with insulin, a PPARγ agonist, or an insulin secretagogue (e.g. a sulfonylurea or glitinide).
- Any patient with an HbA1c ≥8.5%. (See Section 6.3.8.4 for Safety Measures for Enrolled Subjects with Type 2 Diabetes Mellitus.)
- History or clinical/investigational evidence of congestive heart failure defined by the New York Heart Association criteria (Class I to IV cardiac status; Appendix 6).
- History of cardiovascular event within the last 6 months (i.e. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina] or significant arrhythmia; or major intervention (e.g. cardiac surgery or angiography plus stenting) scheduled).
- History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, major depressive disorder (according to DSM-IV) in the past year, or current active depression requiring initiation of treatment. (Note: If not currently treated, but active depression is suspected, the Cornell Scale for Depression in Dementia (CSDD, Appendix 7) can be used by the Investigator as a guide for deciding whether a prospective subject requires treatment. If the subject has a CSDD score >7, the Investigator should decide if the subject has depression in need of prescribed medication, and a CSDD >12 is considered a strong indicator that treatment is needed. Subjects will be allowed to re-screen after their depression has been adequately managed for >3 months.)
- History or presence of gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
- Clinically significant peripheral edema at the time of screening.
- Current or recent drug or alcohol abuse or dependence (defined by DSM-IV criteria for substance-related disorders), or recent or remote history of the same if that could be a contributing factor to the dementia.
- Systolic blood pressure >165 or <90 mmHg or diastolic blood pressure >95 or <60 mmHg at the time of screening.
- Clinically significant anemia (i.e. hemoglobin <11 g/dL for males or <10 g/dL for females) or presence of hemoglobinopathies which would prevent accurate assessment of HbA1c.
- Abnormal kidney function tests (>1.5 times the upper limit of normal (ULN)).
- ALT, AST, or alkaline phosphatase values >2.5 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). (Note: For subjects with a diagnosis of Gilberts Syndrome and an isolated increase in total bilirubin >1.5 ULN, fractionation should be performed. If all of the following conditions are met, the patient may enter or remain in the study, even if total bilirubin >1.5 ULN:
- an elevated unconjugated (indirect) bilirubin;
- the percentage of direct bilirubin <35%;
- ALT, AST, and alkaline phosphatase <2.5 ULN if subject is in screening (<2.0 ULN for Canadian subjects only), or ≤3 ULN if subject is already randomized into the study)
- History of a bone marrow transplant.
- Subject is unable (with assistance, if appropriate) to take study medication as prescribed throughout the study or is at risk of non-compliance with study medication or procedures.
- Subject is an immediate family member or employee of the participating Investigator, of any of the participating site staff, or of GSK.
- In France, a subject is neither affiliated with nor a beneficiary of a social security category.
- The French subject has participated in any study using an investigational drug during the previous 30 days or 5 half-lives (whichever is longer).
- Cognitive tasks prescribed for cognitive rehabilitation and performed under medical supervision are prohibited for 6 months prior to Screening, as well as for the duration of the study.
Trial location(s)
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Study Complete
Location
GSK Investigational Site
Jenkintown, Pennsylvania, United States, 19046
Status
Study Complete
Location
GSK Investigational Site
Kentville, Nova Scotia, Canada, B4N 4K9
Status
Study Complete
Location
GSK Investigational Site
Willows, X14, Pretoria, South Africa, 0040
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
Status
Study Complete
Location
GSK Investigational Site
Ellwangen, Baden-Wuerttemberg, Germany, 73479
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22903
Status
Study Complete
Location
GSK Investigational Site
Middleton, Wisconsin, United States, 53562-2215
Status
Study Complete
Location
GSK Investigational Site
Woodville, South Australia, Australia, 5011
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19115
Status
Study Complete
Location
GSK Investigational Site
Redlands, California, United States, 92374
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rochester, New York, United States, 14620
Status
Study Complete
Location
GSK Investigational Site
Aalen, Baden-Wuerttemberg, Germany, 73430
Status
Study Complete
Location
GSK Investigational Site
Chermside, Queensland, Australia, 4032
Status
Study Complete
Location
GSK Investigational Site
West End, Southampton, United Kingdom, SO30 3JB
Status
Study Complete
Location
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 59100
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West of Scotland Science Park, Glasgow, United Kingdom, G20 0XA
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Ludwigsburg, Baden-Wuerttemberg, Germany, 71634
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98108
Status
Study Complete
Location
GSK Investigational Site
Waverley, Bloemfontein, South Africa, 9301
Status
Study Complete
Location
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Wichita Falls, Texas, United States, 76309
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
Sun City, Arizona, United States, 85351
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94109
Status
Study Complete
Location
GSK Investigational Site
Auchenflower, Queensland, Australia, 4066
Status
Study Complete
Location
GSK Investigational Site
Delray Beach, Florida, United States, 33445
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02906
Status
Study Complete
Location
GSK Investigational Site
Eatontown, New Jersey, United States, 07724
Status
Study Complete
Location
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Status
Study Complete
Location
GSK Investigational Site
West Yarmouth, Massachusetts, United States, 02673
Status
Study Complete
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01104
Status
Study Complete
Location
GSK Investigational Site
Laguna Hills, California, United States, 92653
Status
Study Complete
Location
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY2 0JH
Status
Study Complete
Location
GSK Investigational Site
Hialeah, Florida, United States, 33016
Status
Study Complete
Location
GSK Investigational Site
Calw, Baden-Wuerttemberg, Germany, 75365
Status
Study Complete
Location
GSK Investigational Site
Centerville, Ohio, United States, 45459
Status
Study Complete
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1W 4V5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 50586
Status
Study Complete
Location
GSK Investigational Site
Manchester, New Jersey, United States, 08759
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89075
Status
Study Complete
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
Bad Saarow, Brandenburg, Germany, 15526
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saint John, New Brunswick, Canada, E2L 3L6
Status
Study Complete
Location
GSK Investigational Site
Deerfield Beach, Florida, United States, 33064
Status
Study Complete
Location
GSK Investigational Site
Peterborough, Ontario, Canada, K9H 2P4
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Study Complete
Location
GSK Investigational Site
Heidelberg West, Victoria, Australia, 3084
Status
Study Complete
Location
GSK Investigational Site
Wiesloch, Baden-Wuerttemberg, Germany, 69168
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33702
Status
Study Complete
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Norristown, Pennsylvania, United States, 19401
Status
Study Complete
Location
GSK Investigational Site
Hornsby, New South Wales, Australia, 2077
Status
Study Complete
Location
GSK Investigational Site
Amherst, New York, United States, 14226
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89073
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10032
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Status
Study Complete
Location
GSK Investigational Site
Stirling, United Kingdom, FK8 1RW
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Toms River, New Jersey, United States, 08755
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2J2
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70176
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Norwalk, Connecticut, United States, 06851
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19102
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60610
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
2009-20-03
Actual study completion date
2009-20-03
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.
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