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Trial record 17 of 31 for:    alzheimer dijon

Rosiglitazone (Extended Release Tablets) As Adjunctive Therapy For Subjects With Mild To Moderate Alzheimer's Disease (REFLECT-2)

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ClinicalTrials.gov Identifier: NCT00348309
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: Rosiglitazone Extended Release 2mg
Drug: Rosiglitazone Extended Release 8mg
Other: Placebo
Other: Donepezil

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted on participants with mild to moderate Alzheimer’s disease(AD), who received donepezil for at least 6 months and who received a stable dose of donepezil for at least 2 months immediately before study entry from 06 July 2006 to 28 January 2009 across 228 centers of 19 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1496 participants were randomized for the study, out of which seventeen participants did not receive study medication. A total of 1479 were included in the Safety population.

Reporting Groups
  Description
Placebo Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
2mg Rosiglitazone Extended Release Participants received rosiglitazone extended release 2 milligram (mg) tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
8mg Rosiglitazone Extended Release Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.

Participant Flow:   Overall Study
    Placebo   2mg Rosiglitazone Extended Release   8mg Rosiglitazone Extended Release
STARTED   496   494   489 
COMPLETED   362   396   346 
NOT COMPLETED   134   98   143 
Adverse Event                56                28                63 
Lost to Follow-up                6                7                4 
Protocol Violation                7                12                7 
Withdrawal by Subject                33                37                40 
Non-compliance                8                6                8 
Death of caregiver                1                0                1 
Lack of insight, dementia                1                0                0 
Wrong bottle allocated                1                0                0 
Caregiver sick                1                0                0 
Use of prohibited medication                5                2                2 
Caregiver withdrawal                3                0                7 
Unable to complete ET visit                1                0                0 
PI closing medical practice                1                0                0 
Principal investigator's decision                1                0                0 
No disponibility of medication                1                0                0 
Worsened neurodegenerative disease                1                0                0 
Cognitive and behaviour worsening                2                0                0 
Worsening of alzheimer                1                0                1 
Did not appear in time for Visit 3                1                0                0 
Participant died                2                1                1 
Decision of sponsor                1                0                0 
Ineffectiveness of treatment                0                1                0 
A foul of exclusion criteria                0                1                0 
Participant was hospitalized                0                1                0 
Sponsor refuseal                0                1                1 
Forgot often medication                0                1                0 
Medical Monitor decision                0                0                1 
Increased dose of Aricept                0                0                1 
Site closure                0                0                1 
Adverse event not attended                0                0                1 
ECG abnormal                0                0                2 
Cardiologist recommendations                0                0                1 
HCV career                0                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
2mg Rosiglitazone Extended Release Participants received rosiglitazone extended release 2 milligram (mg) tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
8mg Rosiglitazone Extended Release Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.
Total Total of all reporting groups

Baseline Measures
   Placebo   2mg Rosiglitazone Extended Release   8mg Rosiglitazone Extended Release   Total 
Overall Participants Analyzed 
[Units: Participants]
 496   494   489   1479 
Age 
[Units: Years]
Mean (Standard Deviation)
 74.2  (7.95)   74.5  (8.06)   74.4  (7.83)   74.4  (7.94) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      304  61.3%      286  57.9%      305  62.4%      895  60.5% 
Male      192  38.7%      208  42.1%      184  37.6%      584  39.5% 
Race/Ethnicity, Customized 
[Units: Participants]
       
Hispanic or Latino   97   86   82   265 
Not Hispanic or Latino   399   408   407   1214 


  Outcome Measures

1.  Primary:   Change From Baseline in Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) Total Score at Week 48   [ Time Frame: Baseline (Week 0) and Week 48 ]

2.  Primary:   Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) at Week 48 for APOE E4   [ Time Frame: Baseline (Week 0) and Week 48 ]

3.  Secondary:   Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score   [ Time Frame: Baseline (Week 0), Week 8, 16, 24 and 48 ]

4.  Secondary:   Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score   [ Time Frame: Baseline (Week 0), Week 8, 16, 24 and 48 ]

5.  Secondary:   Change From Screening in Mini Mental State Examination (MMSE) Total Score   [ Time Frame: Screening (Week -4) and Week 48 ]

6.  Secondary:   Change From Baseline in the Domains of the Resource Utilization in Dementia Scale (RUD)   [ Time Frame: Baseline (Week 0), Week 12, 24, 36 and 48 ]

7.  Secondary:   Change From Baseline in European Quality of Life-5 Dimensions Proxy Version (EQ-5D Proxy) Scale Total Score Assessed by Thermometer (Visual Analog Scale [VAS]) and Utility   [ Time Frame: Baseline (Week 0), Week 12, 36 and 48 ]

8.  Secondary:   Change From Baseline in ADAS-Cog Total Score for Observed Cases at Weeks 8, 16, 24, 36 and 48   [ Time Frame: Baseline (Week 0), Week 8, 16, 24, 36 and 48 ]

9.  Secondary:   Change From Baseline in CDR-SB Score for Observed Cases at Weeks 12, 24, 36 and 48   [ Time Frame: Baseline (Week 0), Week 12, 24, 36 and 48 ]

10.  Secondary:   Change in ADAS-Cog Total Score for Observed Cases at Week 54 Compared to Week 48   [ Time Frame: Week 48 and 54 ]

11.  Secondary:   Change in CDR-SB Total Score at Week 54 Compared to Week 48   [ Time Frame: Week 48 and 54 ]

12.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 48   [ Time Frame: Baseline (Week 0) and Week 48 ]

13.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to Week 54 ]

14.  Secondary:   Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP)   [ Time Frame: Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56 ]

15.  Secondary:   Mean Change From Baseline in Heart Rate   [ Time Frame: Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56 ]

16.  Secondary:   Mean Change From Baseline in Weight   [ Time Frame: Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56 ]

17.  Secondary:   Change From Baseline in Hemoglobin Values   [ Time Frame: Baseline (Week 0), Week 4, 16, 36 and 48 ]

18.  Secondary:   Change From Baseline in Hematocrit Values   [ Time Frame: Baseline (Week 0), Week 4, 8, 12, 16, 36 and 48 ]

19.  Secondary:   Mean Change From Baseline in Short Term Memory Assessment Score   [ Time Frame: Baseline (Week 0), Week 8, 16, 24, 36, 48 and 56 ]

20.  Secondary:   Change From Baseline in HbA1c at Week 12, Week 24 and Week 36   [ Time Frame: Baseline (Week 0) and Week 12, 24 and 36 ]

21.  Secondary:   Number of Participants With Laboratory Potential Clinical Concern (PCC) Values   [ Time Frame: Baseline (Week 0), Week 4, 8, 12, 16, 24, 36, 48 and 56 ]

22.  Secondary:   Change From Baseline in Alzheimer’s Carer Quality of Life Instrument (ACQLI) Total Score   [ Time Frame: Baseline (Week 0), Week 12, 36 and 48 ]


  Serious Adverse Events

Time Frame Up to Week 48
Additional Description An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug .The data was reported for prospective period. Participants with available data in the prospective period were analysed.

Reporting Groups
  Description
Placebo Participants received rosiglitazone extended release matching placebo tablet orally, once daily until Week 54.
2mg Rosiglitazone Extended Release Participants received rosiglitazone extended release 2 mg tablet orally, once daily until Week 48 followed by placebo tablet orally once daily until Week 54.
8mg Rosiglitazone Extended Release Participants received rosiglitazone extended release 4 mg tablet orally, once daily until Week 4 followed by 8 mg tablet orally once daily from Week 4 until Week 48 followed by placebo tablet orally once daily until Week 54.

Serious Adverse Events
    Placebo   2mg Rosiglitazone Extended Release   8mg Rosiglitazone Extended Release
Total, All-Cause Mortality       
# participants affected / at risk   12/496 (2.42%)   6/494 (1.21%)   8/489 (1.64%) 
Total, Serious Adverse Events       
# participants affected / at risk   62/496 (12.50%)   45/494 (9.11%)   50/489 (10.22%) 
Blood and lymphatic system disorders       
Iron deficiency anaemia † 1       
# participants affected / at risk   1/496 (0.20%)   1/494 (0.20%)   0/489 (0.00%) 
Anaemia † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Normochromic normocytic anaemia † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Cardiac disorders       
Myocardial infarction † 1       
# participants affected / at risk   5/496 (1.01%)   1/494 (0.20%)   0/489 (0.00%) 
Cardiac arrest † 1       
# participants affected / at risk   2/496 (0.40%)   2/494 (0.40%)   1/489 (0.20%) 
Angina pectoris † 1       
# participants affected / at risk   1/496 (0.20%)   1/494 (0.20%)   0/489 (0.00%) 
Atrial fibrillation † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   2/489 (0.41%) 
Bradycardia † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   1/489 (0.20%) 
Cardiac failure congestive † 1       
# participants affected / at risk   1/496 (0.20%)   1/494 (0.20%)   0/489 (0.00%) 
Coronary artery stenosis † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   1/489 (0.20%) 
Myocardial ischaemia † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   2/489 (0.41%) 
Acute myocardial infarction † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Cardiac failure † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Cardio-respiratory arrest † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Coronary artery disease † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Sick sinus syndrome † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Tachyarrhythmia † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Ear and labyrinth disorders       
Vertigo † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Eye disorders       
Angle closure glaucoma † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Cataract † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Gastrointestinal disorders       
Inguinal hernia † 1       
# participants affected / at risk   0/496 (0.00%)   2/494 (0.40%)   0/489 (0.00%) 
Colonic polyp † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Diarrhoea † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Diverticulum intestinal † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Duodenal ulcer haemorrhage † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Haemorrhoids † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Large intestine perforation † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Peptic ulcer perforation † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Rectal haemorrhage † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Rectal polyp † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
General disorders       
Malaise † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   1/489 (0.20%) 
Death † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Oedema peripheral † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Hepatobiliary disorders       
Bile duct stone † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Cholecystitis † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Cholelithiasis † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Hepatitis toxic † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Jaundice † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Infections and infestations       
Pneumonia † 1       
# participants affected / at risk   5/496 (1.01%)   1/494 (0.20%)   6/489 (1.23%) 
Urinary tract infection † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   2/489 (0.41%) 
Appendicitis † 1       
# participants affected / at risk   0/496 (0.00%)   2/494 (0.40%)   0/489 (0.00%) 
Bronchitis † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   1/489 (0.20%) 
Bronchopneumonia † 1       
# participants affected / at risk   1/496 (0.20%)   1/494 (0.20%)   0/489 (0.00%) 
Diverticulitis † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Gastroenteritis † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Gastroenteritis norovirus † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Gastroenteritis rotavirus † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Gastrointestinal infection † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Herpes zoster † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Lung infection † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Pneumonia primary atypical † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Pyelonephritis † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Sinusitis † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Viral infection † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Injury, poisoning and procedural complications       
Hip fracture † 1       
# participants affected / at risk   3/496 (0.60%)   4/494 (0.81%)   1/489 (0.20%) 
Femoral neck fracture † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   3/489 (0.61%) 
Fall † 1       
# participants affected / at risk   1/496 (0.20%)   1/494 (0.20%)   1/489 (0.20%) 
Humerus fracture † 1       
# participants affected / at risk   1/496 (0.20%)   1/494 (0.20%)   1/489 (0.20%) 
Femur fracture † 1       
# participants affected / at risk   2/496 (0.40%)   0/494 (0.00%)   0/489 (0.00%) 
Concussion † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Contusion † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Dislocation of joint † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Face injury † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Injury † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Ligament rupture † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Lower limb fracture † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Meniscus lesion † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Overdose † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Pelvic fracture † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Radius fracture † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Rib fracture † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Spinal compression fracture † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Tibia fracture † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Investigations       
Platelet count decreased † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Weight decreased † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Metabolism and nutrition disorders       
Dehydration † 1       
# participants affected / at risk   1/496 (0.20%)   2/494 (0.40%)   0/489 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1       
# participants affected / at risk   1/496 (0.20%)   1/494 (0.20%)   0/489 (0.00%) 
Arthropathy † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Lateral patellar compression syndrome † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Muscle spasms † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Pain in extremity † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lymphoma † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   2/489 (0.41%) 
Basal cell carcinoma † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Bile duct cancer † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Bile duct cancer recurrent † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Breast cancer † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Hepatic neoplasm malignant † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Intraductal papilloma of breast † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Prostate cancer † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Sarcoma † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Uterine neoplasm † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Nervous system disorders       
Syncope † 1       
# participants affected / at risk   1/496 (0.20%)   3/494 (0.61%)   2/489 (0.41%) 
Cerebrovascular accident † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   1/489 (0.20%) 
Cerebral haemorrhage † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Convulsion † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Dementia Alzheimer's type † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Dizziness † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Epilepsy † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Haemorrhagic stroke † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Loss of consciousness † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Transient ischaemic attack † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Vertebrobasilar insufficiency † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Psychiatric disorders       
Confusional state † 1       
# participants affected / at risk   2/496 (0.40%)   0/494 (0.00%)   1/489 (0.20%) 
Aggression † 1       
# participants affected / at risk   1/496 (0.20%)   1/494 (0.20%)   0/489 (0.00%) 
Agitation † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   1/489 (0.20%) 
Anxiety † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Delirium † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Delusion † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Depression † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Hallucination † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Panic attack † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Psychotic disorder due to a general medical condition † 1       
# participants affected / at risk   0/496 (0.00%)   1/494 (0.20%)   0/489 (0.00%) 
Suicidal ideation † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Suicide attempt † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Renal and urinary disorders       
Renal failure acute † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia † 1       
# participants affected / at risk   2/496 (0.40%)   0/494 (0.00%)   0/489 (0.00%) 
Metrorrhagia † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Lung disorder † 1       
# participants affected / at risk   2/496 (0.40%)   0/494 (0.00%)   1/489 (0.20%) 
Pulmonary embolism † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   1/489 (0.20%) 
Bronchospasm † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Interstitial lung disease † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
# events      0    
Skin and subcutaneous tissue disorders       
Skin fissures † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Skin ulcer † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Vascular disorders       
Aortic aneurysm † 1       
# participants affected / at risk   1/496 (0.20%)   1/494 (0.20%)   1/489 (0.20%) 
Aortic dissection † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Deep vein thrombosis † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Haematoma † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Hypertensive crisis † 1       
# participants affected / at risk   1/496 (0.20%)   0/494 (0.00%)   0/489 (0.00%) 
Venous thrombosis † 1       
# participants affected / at risk   0/496 (0.00%)   0/494 (0.00%)   1/489 (0.20%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA




  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00348309     History of Changes
Other Study ID Numbers: AVA102672
First Submitted: June 30, 2006
First Posted: July 4, 2006
Results First Submitted: April 21, 2017
Results First Posted: November 28, 2017
Last Update Posted: November 28, 2017