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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00428090




Registration number
NCT00428090
Ethics application status
Date submitted
25/01/2007
Date registered
29/01/2007

Titles & IDs
Public title
Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease
Scientific title
A 24-week, Double-blind, Double-dummy, Randomized, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets), Donepezil, and Placebo as Monotherapy on Cognition and Overall Clinical Response in APOE e4-stratified Subjects With Mild to Moderate Alzheimer's Disease. (REFLECT-1)
Secondary ID [1] 0 0
105640
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rosiglitazone

Experimental: Rosiglitazone - XR (extended release) oral tablets

Other: Placebo - Placebo (Double-Dummy to Match)


Treatment: Drugs: Rosiglitazone
XR (extended release) oral tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Apolipoprotein epsilon4 (APOE e4) Negative Cohort
Assessment method [1] 0 0
The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. The adjusted means were presented. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.
Timepoint [1] 0 0
Baseline (W0) and W24
Primary outcome [2] 0 0
Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort
Assessment method [2] 0 0
The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.
Timepoint [2] 0 0
Baseline (W0) and W24
Primary outcome [3] 0 0
Change From Baseline (W0) in Mean ADAS-Cog Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort
Assessment method [3] 0 0
The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Items were evaluated by tests and clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicates more dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.
Timepoint [3] 0 0
Baseline (W0) and W24
Primary outcome [4] 0 0
Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in APOE4 Negative Cohort
Assessment method [4] 0 0
The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.
Timepoint [4] 0 0
Baseline (W0) and W24
Primary outcome [5] 0 0
Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in All Except e4/e4's Cohort
Assessment method [5] 0 0
The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.
Timepoint [5] 0 0
Baseline (W0) and W24
Primary outcome [6] 0 0
Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W24 as a Function of APOE e4 Status in Full Population Cohort
Assessment method [6] 0 0
The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means greater dysfunction. It was based on interviews with the par. and caregiver by an independent rater. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. Estimated value was calculated by Active treatment minus Placebo. A hierarchical testing procedure was used to control for the two rosiglitazone dose groups and the three genetic subgroups. There was no adjustment for the donepezil versus placebo comparisons, which were included to assess the sensitivity of the trial to detect a treatment effect.
Timepoint [6] 0 0
Baseline (W0) and W24
Secondary outcome [1] 0 0
Change From Baseline (W0) in Mean ADAS-Cog Total Score at W8, W16, W24
Assessment method [1] 0 0
The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a 5-point scale. Scores ranged from 0-70 with higher scores indicating greater dysfunction. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline is defined as value at W0. Endpoint treatment differences were adjusted to take account of missing data. It was evaluated at Baseline, W8, W16 and W24.
Timepoint [1] 0 0
Baseline (W0) and up to W24
Secondary outcome [2] 0 0
Change From Baseline (W0) in Mean CIBIC+ Global Functioning Total Score at W8, W16, W24
Assessment method [2] 0 0
The CIBIC+ assessment comprised of a 7-point rating of severity (at baseline) and change (at indicated time points). It was rated on a scale of 1 to 7 as 1: markedly improved, 2.: moderately improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: moderately worse and 7: markedly worse; higher score means more dysfunction. The scale was based on interviews with the par. and caregiver and was completed by an independent rater. It required separate structured 15-20 minute interviews with the par. and caregiver. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived. It was evaluated at Baseline, W8, W16 and W24.
Timepoint [2] 0 0
Baseline (W0) and up to W24
Secondary outcome [3] 0 0
Change From Baseline (W0) in Mean Neuropsychiatric Inventory (NPI) Total Score at W8, W16, W24
Assessment method [3] 0 0
The NPI assessed behavioral disturbances comprises 10 dimensions: delusions, hallucinations, dysphoria, apathy, euphoria, disinhibition, aggressiveness and agitation, irritability, anxiety and aberrant motor activity. The par. caregiver asked about behavior in the par. If "Yes", the informant then rates both the severity on a 3-point scale, 1: mild to 3: severe (total range: 0-36) and the frequency using a 4-point scale, 1: occasionally to 4: very frequently. The total domain score was frequency × severity. The distress was scored on 5-point scale, 0: no distress to 5 - very severe or extreme. A total NPI score can be calculated by adding all domain scores together; NPI total score: from 0-144 and NPI distress score: from 0-60, all with higher scores indicating more severe behavioral disturbance. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.
Timepoint [3] 0 0
Baseline (W0) and up to W24
Secondary outcome [4] 0 0
Change From Baseline (W0) in Mean Disability Assessment for Dementia (DAD) Scale Total Score at W8, W16, W24
Assessment method [4] 0 0
The DAD, assessed the ability of a par. to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. The percentage score was calculated as (DAD total score/total number of applicable items) multiplied by 100. Endpoint treatment differences which were adjusted to take account of missing data are derived.
Timepoint [4] 0 0
Baseline (W0) and up to W24
Secondary outcome [5] 0 0
Change From Baseline (W0) in Mean Short Term Memory Assessment Total Score (ADAS-Cog Q1 Plus Q7) at W8, W16, W24
Assessment method [5] 0 0
Change from Baseline in short term memory assessment score was assessed from a combined analysis of items 1 (word recall task) and 7 (word recognition task) of ADAS-Cog scale. Word recall task consist of the participants score was the mean number of words not recalled on three trials (maximum score 10) and word recognition task, to score this item the number of incorrect responses was counted (maximum error score was 12). Higher score indicating greater dysfunction. Total score is sum of individual score. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.
Timepoint [5] 0 0
Baseline (W0) and up to W24
Secondary outcome [6] 0 0
Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Utility
Assessment method [6] 0 0
The EQ-5D Proxy was a 2 part scale used to assess the quality of life and utility benefit. The data for Part 1 is presented. It is a 5 dimensional Health State Classification. Caregivers were asked to respond as they feel the par. would on dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to each question were recorded on a 3-point scale which indicates the level of impairment (level 1= no problem; level 2=some or moderate problem(s) and level 3=unable, or extreme problem with higher scores indicating greater dysfunction. EQ-5D Proxy assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.
Timepoint [6] 0 0
Baseline (W0) and up to W24
Secondary outcome [7] 0 0
Change From Baseline (W0) in Mean European Quality of Life -5 Dimensions Proxy Version (EQ-5D Proxy) Total Score at W12, W24 Assessed by Thermometer (Visual Analog Scale [VAS])
Assessment method [7] 0 0
The EQ-5D Proxy is a 2 part scale used to assess the quality of life and utility benefit. The data for Part 2 is presented. It is a the visual analogue scale Thermometer which assessed caregiver's impression of par. overall health. The Thermometer has endpoints of 100 (best imaginable health state) and 0 (worst imaginable health state). EQ-5D Proxy assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.
Timepoint [7] 0 0
Baseline (W0) and up to W24
Secondary outcome [8] 0 0
Time Spent Caring for Basic and Instrumental Activities Resource Utilization in Dementia (RUD) Scale at W12 and W24
Assessment method [8] 0 0
The RUD instrument was developed as a comprehensive tool to assess the amount of resource use among demented par. RUD assess both formal and informal resource use of the par. and the primary caregiver, making it possible to calculate costs from a societal perspective. Q1 relates to assisting par. with basic activities of daily living and Q2 relates to instrumental activities of daily living. The assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.
Timepoint [8] 0 0
Baseline (W0) and up to W24
Secondary outcome [9] 0 0
Change From Baseline (W0) in Alzheimer's Carer's Quality of Life Instrument (ACQLI) Score at W12 and W24.
Assessment method [9] 0 0
The ACQLI was an assessment of caregiver quality of life. This instrument consists of 30 questions exploring various aspects of carer's quality of life. Each of the questions had a two point response and the 30 questions were summed to provide a total score. Items are assumed to be unidimensional (i.e., represent a single variable) and are scored 0/1 (false/true) before summation into a total score with a 0-30 range. To ease comparisons between scales, ACQLI scores were transformed to range between 0-100 (100: worse). The assessments was performed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.
Timepoint [9] 0 0
Baseline (W0) and up to W24
Secondary outcome [10] 0 0
Change From Baseline (W0) in Mini Mental State Examination (MMSE) Total Score at W24.
Assessment method [10] 0 0
The MMSE consists of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. The scale is completed by the investigator, based on the performance of the par. and takes approximately 5 to 10 minutes to administer. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived
Timepoint [10] 0 0
Baseline (W0) and W24
Secondary outcome [11] 0 0
Change From Baseline (W0) in Glycosylated Hemoglobin (HbA1c) at W24.
Assessment method [11] 0 0
The blood sample was collected for assessments of HbA1c levels at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0. Endpoint treatment differences which were adjusted to take account of missing data are derived.
Timepoint [11] 0 0
Baseline (W0) and W24
Secondary outcome [12] 0 0
Number of Participants With Adverse Events Defined by Severity
Assessment method [12] 0 0
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE included significant or unexpected worsening or exacerbation of the condition/indication under study, exacerbation of a chronic or intermittent pre-existing condition, new conditions detected or diagnosed, signs, symptoms, or the clinical sequelae of a suspected overdose of either investigational product or a concurrent medication. Number of participants with any AE and as per severity were reported. Refer to the general AE/SAE module for a list of AEs and SAEs.
Timepoint [12] 0 0
Up to W24
Secondary outcome [13] 0 0
Number of Participants With Systolic and Diastolic Blood Pressure (SBP and DBP), Heart Rate (HR) and Weight Values of Potential Clinical Concern (PCC) Any Time on Treatment (ATOT).
Assessment method [13] 0 0
SBP, DBP and HR of par. were recorded in sitting posture as vital signs, while body weight was measured without shoes and wearing light clothing at each visit. The blood pressure (BP) and HR values were identified as of PCC if the vales were out of the reference range (for SBP, 90 to 140 millimeters of mercury (mmHg), DBP, 50 to 90 mmHg, and HR \>100 or \<50 beats per minute \[bpm\]) or meet a change from Baseline criterion. For SBP it was increase from Baseline (high) if increased by more than or equal to (\>=) 40 mmHg; decrease from Baseline (low) if decreased by \>=30 mmHg. For DBP, increase from Baseline (high) if increased by \>=30 mmHg; decrease from Baseline (low) if decreased by \>=20 mmHg. For HR, increase from Baseline (high) if increased by \>=30 bpm; decrease from Baseline (low) if decreased by \>=30 bpm. For weight, increase from Baseline (high) if increased by \>=7%; decrease from Baseline (low) if decreased by \>=7%. Baseline was defined as value at W0.
Timepoint [13] 0 0
Up to W24
Secondary outcome [14] 0 0
Change From Baseline (W0) in 12-lead Electrocardiogram (ECG)
Assessment method [14] 0 0
Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the par. had rested in the supine position in a quiet room (no TV, minimal talking) for at least 10 minutes. Conduction intervals from the 12-lead ECGs were manually read and confirmed by an external cardiologist/vendor. The ECG parameters includes PR interval, QRS duration, QT - uncorrected interval, QTc Bazett (QTcB), QTc Fridericia (QTcF) and RR interval of Central Cardiologist are reported. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Screening/Visit 1/W-6.
Timepoint [14] 0 0
Baseline (W0) and up to W24
Secondary outcome [15] 0 0
Change From Baseline (W0) in Heart Rate (HR) Measured From 12-lead Electrocardiogram (ECG)
Assessment method [15] 0 0
Triplicate 12-lead ECG measures was obtained digitally, approximately one minute apart after the par. had rested in the supine position in a quiet room (no TV, minimal talking) for at least 10 minutes. Conduction intervals from the 12-lead ECGs were manually read and confirmed by an external cardiologist/vendor. The ECG HR of Central Cardiologist reported. The assessments was performed at Baseline and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at Screening/Visit 1/W-6.
Timepoint [15] 0 0
Baseline (W0) and up to W24
Secondary outcome [16] 0 0
Change From Baseline (W0) in Body Weight
Assessment method [16] 0 0
Body weight will be measured at all visits, without shoes and wearing light clothing. The assessments was performed at Baseline, W4, W8, W12, W16, and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.
Timepoint [16] 0 0
Baseline (W0) and up to W24
Secondary outcome [17] 0 0
Change From Baseline (W0) in Hemoglobin
Assessment method [17] 0 0
Hematology parameters were assessed at Baseline, W4, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.
Timepoint [17] 0 0
Baseline (W0) and up to W24
Secondary outcome [18] 0 0
Change From Baseline (W0) in Hematocrit
Assessment method [18] 0 0
Hematology parameters were assessed at Baseline, W4, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.
Timepoint [18] 0 0
Baseline (W0) and Up to W24
Secondary outcome [19] 0 0
Change From Baseline (W0) in Periodic HbA1c Assessment
Assessment method [19] 0 0
HbA1c assessment was performed par. with type 2 diabetes mellitus or HbA1c \>=6.5% at Screening only. HbA1c levels were assessed at Baseline, W12 and W24. Change from Baseline was calculated as value at scheduled time point minus Baseline value. Baseline was defined as value at W0.
Timepoint [19] 0 0
Baseline (W0) and up to W24
Secondary outcome [20] 0 0
Number of Par. With Hematology Data of Potential Clinical Concern Any Time on Treatment
Assessment method [20] 0 0
Haematology parameters were identified as of PCC (high \[H\], low \[L\]), if the values were out of the reference range (RR). The range for parameters was: platelet (100AV-500AV), red blood cell (RBC, 0.8-1.2), hemoglobin (L: female \[F\]:10, male \[M\]:11; H: F:16.5-AV, M:18), hematocrit (0.8-1.2), white blood cell (WBC, 3-15), neutrophils (0.75-1.5), lymphocytes (0.75-1.5), monocytes (0.75-2), eosinophils (none-2), basophils (none-2), mean corpuscle volume (MCV, 0.8-1.2), mean corpuscular hemoglobin (MCH, 0.8-1.2), mean corpuscular hemoglobin concentration (MCHC, 0.8-1.2), red cell distribution width (RDW, 0.8-1.2). Data for mean platelet volume (reference range not established) not reported
Timepoint [20] 0 0
Up to W24
Secondary outcome [21] 0 0
Number of Par. With Clinical Chemistry Values of Potential Clinical Concern Any Time on Treatment
Assessment method [21] 0 0
Clinical chemistry parameters were identified as of PCC (H, L), if values were out of RR: Alanine aminotransferase (ALT, none-120 \[250% upper limit of RR, ULRR\]), Albumin (0.75-2), Aspartate aminotransferase (AST,none-105 (3-64y), 137.5 (65+y), \>250%ULRR), Alkaline phosphatase (ALP,none-312.5 (20+y), \>250%ULRR), blood urea nitrogen (BUN)/Creatinine ratio (none-1.25), BUN (none-11), Chloride (80-115), Calcium (0.75-1.25), Carbon dioxide (CO2, 15-40) content, Creatinine (22, \<50% lower limit of RR \[LLRR\]-155, \>125%ULRR), Creatine phosphokinase (CPK, none-1.25), Gamma glutamyl transferase (GGT,none-2.5), Glucose (3.6-7.8), High density lipoprotein (HDL,0.65-none), Lactate dehydrogenase (LDH,none-1.25), Low density lipoprotein (LDL,none-2), Magnesium (0.5-2), Potassium (3-5.5), Phosphorus inorganic (0.5-1.5), Sodium (130-150), Total protein (0.8-1.5), Total cholesterol (none-1.25), Total bilirubin (none-1.95), Triglycerides (none-9). Data for Creatinine clearance not reported.
Timepoint [21] 0 0
Up to W24

Eligibility
Key inclusion criteria
Inclusion criteria:

* Clinical diagnosis of probable Alzheimer's Disease (AD).
* MMSE score 10 to 23
* Has not taken an approved AD therapy in last 30 days.
* No previous hypersensitivity/intolerance to AChEIs
* Have a regular caregiver.
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Diagnosis of vascular dementia.
* Type I or secondary diabetes mellitus.
* Type II diabetes mellitus treated with insulin, sulfonylurea or glipizide.
* History or evidence of congestive heart failure, clinically significant peripheral edema or anemia.
* History of significant psychiatric illness, major depressive disorder or current depression needing initiation of treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/09/2008
Sample size
Target
Accrual to date
Final
862
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Nevada
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Austria
State/province [17] 0 0
Graz-Eggenberg
Country [18] 0 0
Austria
State/province [18] 0 0
Hall in Tirol
Country [19] 0 0
Austria
State/province [19] 0 0
Linz
Country [20] 0 0
Austria
State/province [20] 0 0
Vienna
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Plovdiv
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Sofia
Country [23] 0 0
Chile
State/province [23] 0 0
Región Metro De Santiago
Country [24] 0 0
Chile
State/province [24] 0 0
Valparaíso
Country [25] 0 0
China
State/province [25] 0 0
Guangdong
Country [26] 0 0
China
State/province [26] 0 0
Beijing
Country [27] 0 0
China
State/province [27] 0 0
Shanghai
Country [28] 0 0
China
State/province [28] 0 0
Tianjin
Country [29] 0 0
Croatia
State/province [29] 0 0
Dubrovnik
Country [30] 0 0
Croatia
State/province [30] 0 0
Zagreb
Country [31] 0 0
Estonia
State/province [31] 0 0
Tallinn
Country [32] 0 0
Estonia
State/province [32] 0 0
Tartu
Country [33] 0 0
Germany
State/province [33] 0 0
Baden-Wuerttemberg
Country [34] 0 0
Germany
State/province [34] 0 0
Bayern
Country [35] 0 0
Germany
State/province [35] 0 0
Hessen
Country [36] 0 0
Germany
State/province [36] 0 0
Mecklenburg-Vorpommern
Country [37] 0 0
Germany
State/province [37] 0 0
Niedersachsen
Country [38] 0 0
Germany
State/province [38] 0 0
Nordrhein-Westfalen
Country [39] 0 0
Germany
State/province [39] 0 0
Sachsen-Anhalt
Country [40] 0 0
Germany
State/province [40] 0 0
Sachsen
Country [41] 0 0
Germany
State/province [41] 0 0
Schleswig-Holstein
Country [42] 0 0
Germany
State/province [42] 0 0
Thueringen
Country [43] 0 0
Germany
State/province [43] 0 0
Berlin
Country [44] 0 0
Germany
State/province [44] 0 0
Hamburg
Country [45] 0 0
Greece
State/province [45] 0 0
Athens
Country [46] 0 0
Greece
State/province [46] 0 0
Melissia
Country [47] 0 0
Greece
State/province [47] 0 0
Thessaloniki
Country [48] 0 0
Hungary
State/province [48] 0 0
Budapest
Country [49] 0 0
Hungary
State/province [49] 0 0
Gyula
Country [50] 0 0
Hungary
State/province [50] 0 0
Kaposvár
Country [51] 0 0
Hungary
State/province [51] 0 0
Pécs
Country [52] 0 0
Hungary
State/province [52] 0 0
Szeged
Country [53] 0 0
India
State/province [53] 0 0
Bangalore
Country [54] 0 0
India
State/province [54] 0 0
Nagpur
Country [55] 0 0
India
State/province [55] 0 0
Tirupati
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seongnam-si,
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Seoul
Country [58] 0 0
Mexico
State/province [58] 0 0
Coahuila
Country [59] 0 0
Mexico
State/province [59] 0 0
Nuevo León
Country [60] 0 0
Mexico
State/province [60] 0 0
Mexico
Country [61] 0 0
New Zealand
State/province [61] 0 0
Auckland
Country [62] 0 0
Pakistan
State/province [62] 0 0
Karachi
Country [63] 0 0
Pakistan
State/province [63] 0 0
Lahore
Country [64] 0 0
Peru
State/province [64] 0 0
Lima
Country [65] 0 0
Philippines
State/province [65] 0 0
Pasig City
Country [66] 0 0
Philippines
State/province [66] 0 0
Quezon City
Country [67] 0 0
Puerto Rico
State/province [67] 0 0
Cabo Rojo
Country [68] 0 0
Puerto Rico
State/province [68] 0 0
San Juan
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Moscow
Country [70] 0 0
Russian Federation
State/province [70] 0 0
St. Petersburg
Country [71] 0 0
Russian Federation
State/province [71] 0 0
St.-Petersburg
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Bradford
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Derriford, Plymouth
Country [74] 0 0
United Kingdom
State/province [74] 0 0
West of Scotland Science Park, Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00428090