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Trial record 75 of 450 for:    QUETIAPINE

Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression (QUALITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00883493
Recruitment Status : Completed
First Posted : April 17, 2009
Results First Posted : June 29, 2012
Last Update Posted : July 11, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Bipolar Depression
Interventions Drug: Quetiapine fumarate XR
Drug: Lithium carbonate
Enrollment 421
Recruitment Details First Subject in (FSI): 22 Apr 2009, Last Subject Last Visit (LSLV): 01 Mar 2011, in 9 countries, 29 Psychiatry centres, 421 randomised participants
Pre-assignment Details An enrollment period of up to 7 days and if applicable a wash-out period for 7-28 days depending on the medication being used, ie. antidepressants, antipsychotics and/or mood stabilizers.
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium
Hide Arm/Group Description Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
Period Title: Overall Study
Started 212 209
Intention To Treat Analysis Population 204 195
Per Protocol Analysis Population 162 155
Completed 166 159
Not Completed 46 50
Reason Not Completed
Adverse Event             11             12
Lack of Efficacy             4             3
Lost to Follow-up             7             6
Withdrawal by Subject             11             20
Eligibility Criteria not fullfilled             6             6
Study specific disc. criteria             2             0
Not specified             5             3
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium Total
Hide Arm/Group Description Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day. Total of all reporting groups
Overall Number of Baseline Participants 204 195 399
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 204 participants 195 participants 399 participants
40.6  (10.8) 39.9  (12.1) 40.3  (11.4)
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 204 participants 195 participants 399 participants
40
(19 to 64)
40
(18 to 65)
40
(18 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 204 participants 195 participants 399 participants
Female
147
  72.1%
138
  70.8%
285
  71.4%
Male
57
  27.9%
57
  29.2%
114
  28.6%
Body weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 204 participants 195 participants 399 participants
72.8  (16.3) 72.3  (15.4) 72.5  (15.8)
[1]
Measure Description: The overall number of subject the measures are reported is 398- the weight of one patient from Quatiapine XR + Lithium Arm has not been recorded at baseline.
1.Primary Outcome
Title Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
Hide Description

The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks).

The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.

Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was “Per Protocol” (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit.
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium
Hide Arm/Group Description:
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
Overall Number of Participants Analyzed 162 155
Mean (Standard Deviation)
Unit of Measure: scores on a scale
23.7  (8.4) 24.3  (7.9)
2.Secondary Outcome
Title Response Rate for MADRS.
Hide Description

Response rate defined as the percentage of patients with a ≥50% reduction from baseline in the MADRS total score to the final assessment at week 8.

The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.

Time Frame baseline, week 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was “Per Protocol” (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit.
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium
Hide Arm/Group Description:
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
Overall Number of Participants Analyzed 162 155
Measure Type: Number
Unit of Measure: percentage of participants
93.2 92.9
3.Secondary Outcome
Title Hamilton Rating Scale for Depression (HAM-D) Total Score.
Hide Description

The mean change of HAM-D Total Score from baseline to the end of treatment was calculated by subtracting the HAM-D Total Score assessed at week 8 from the baseline one (Baseline - week 8).

HAM-D is a multiple choice questionnaire used to rate the severity of a patient's major depression. It consists of 17 different items with possible scores from 0 to 4 or 0 to 2 or 0 to 6 depending on the items. Sum the total of all seventeen items gives the HAM-D Total Score, which may range from 0 (min) to 53 (max). The higher the score, the more severe the depression.

Time Frame Baseline, 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was "Per Protocol" (PP).
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium
Hide Arm/Group Description:
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
Overall Number of Participants Analyzed 162 155
Mean (Standard Deviation)
Unit of Measure: scores on a scale
20.5  (7.0) 21.0  (6.1)
4.Secondary Outcome
Title Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Hide Description

The mean change in HAM-A total score from baseline to final assessment was calculated by subtracting the HAM-A Total score assessed at week 8 from the total score assessed at the baseline (baseline - week 8).

The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as “anxious mood”, “tension” or “fears”. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max).

Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was "Per Protocol" (PP).
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium
Hide Arm/Group Description:
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
Overall Number of Participants Analyzed 162 155
Mean (Standard Deviation)
Unit of Measure: scores on a scale
17.5  (8.2) 17.7  (8.2)
5.Secondary Outcome
Title Change in the Clinical Global Impression Severity (CGI-S) Score.
Hide Description

The reported mean change in the CGI-S score was calculated as baseline - week 8.

CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.

Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was “Per Protocol” (PP).
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium
Hide Arm/Group Description:
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
Overall Number of Participants Analyzed 162 155
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.1  (1.4) 3.3  (1.2)
6.Secondary Outcome
Title Change in Young Mania Rating Scale (YMRS) Total Score.
Hide Description

The YMRS is a rating scale to assess manic symptoms. The scale has 11 items and is based upon patient’s subjective report of his or hers clinical condition over the previous 48 hours.

The mean change in YMRS Total score reported was calculated as baseline - week 8.

The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).

Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was “Per Protocol” (PP).
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium
Hide Arm/Group Description:
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
Overall Number of Participants Analyzed 162 155
Mean (Standard Deviation)
Unit of Measure: scores on a scale
2.3  (1.8) 2.2  (1.7)
7.Secondary Outcome
Title Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.
Hide Description

The mean change in PSQI score from baseline to final assessment at week 8 was calculated as baseline - week 8.

PSQI evaluates 7 areas of quality and pattern of sleep: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence). Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.

Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium
Hide Arm/Group Description:
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
Overall Number of Participants Analyzed 75 67
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
3.7
(-20 to 21)
5.0
(-16 to 19)
8.Secondary Outcome
Title Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.
Hide Description

The mean change in (Q-LES-Q–Short Form) Total Score from baseline to week 8 was calculated by subtracting the 8 week value from baseline value (baseline - week 8).

The Q-LES-Q-SF is a patient self assessment questionnaire consisting of 16 self-rated questions (1 being very poor - 5 very good); the first 14 will be incorporated into a total score. Higher scores indicate better quality of life.

Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium
Hide Arm/Group Description:
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
Overall Number of Participants Analyzed 75 64
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-17.9  (12.0) -18.8  (13.4)
9.Secondary Outcome
Title Change in the Sheehan Disability Scale (SDS) Total Score.
Hide Description

The mean change in the SDS Total score from baseline to week 8 (baseline- week 8).

Sheehan Disability Scale is a 5 item scale, with a visual analog scale evaluating work/school work, social life and family life ranging from 0 to a maximum score of 30. Each one of the 3 domains is rated from 0-10 (no impairment to most severe impairment) with evaluation of not at all (0), mild (1-3), moderate (4-6), marked (7-9) and extreme (10) disability. A total score will be calculated. A score of 30 indicates most severe impairment.

Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium
Hide Arm/Group Description:
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
Overall Number of Participants Analyzed 76 66
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
14.4
(-3 to 30)
14.3
(-16 to 30)
10.Secondary Outcome
Title Treatment Satisfaction Questionnaire (TSQ) Scores.
Hide Description

The 14-item TAQ questionnaire evaluates the patient’s overall level of satisfaction with the study medication, the effectiveness, side effects and convenience of the medication.

Effectiveness, side effects, convenience and global satisfaction is rated on a scale of 0 being the worst and 100 being very effective, no side effects or very convenient or very satisfied. Overall satisfaction is rated over a score of 5 and 5 being the best overall satisfaction.

Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium
Hide Arm/Group Description:
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
Overall Number of Participants Analyzed 69 42
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Effectivenes, baseline 42.7  (20.2) 36.7  (23.7)
Effectivenes, week 8 68.7  (24.9) 66.7  (21.8)
Side effects, baseline 41.7  (25.9) 44.4  (24.9)
Side effects, week 8 58.2  (26.7) 50.4  (17.0)
Convenience, baseline 53.8  (21.5) 52.8  (21.8)
Convenience, week 8 73.6  (17.1) 72.9  (17.2)
Global satisfaction, baseline 37.4  (26.1) 35.0  (27.7)
Global satisfaction, week 8 69.4  (19.4) 70.7  (18.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine XR Quatiapine XR + Lithium
Hide Arm/Group Description Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
All-Cause Mortality
Quetiapine XR Quatiapine XR + Lithium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine XR Quatiapine XR + Lithium
Affected / at Risk (%) Affected / at Risk (%)
Total   5/212 (2.36%)   5/209 (2.39%) 
Endocrine disorders     
Hypothyroidism  1  0/212 (0.00%)  1/209 (0.48%) 
Gastrointestinal disorders     
Constipation  1  1/212 (0.47%)  1/209 (0.48%) 
Appendicitis  1  1/212 (0.47%)  0/209 (0.00%) 
Infections and infestations     
Peritonitis  1  1/212 (0.47%)  0/209 (0.00%) 
Injury, poisoning and procedural complications     
Burn  1  0/212 (0.00%)  1/209 (0.48%) 
Nervous system disorders     
Somnolance  1  1/212 (0.47%)  0/209 (0.00%) 
Confusion  1  0/212 (0.00%)  1/209 (0.48%) 
Exacerbation of symptoms  1  1/212 (0.47%)  0/209 (0.00%) 
Psychiatric disorders     
Hospitalization due to suicide risk   0/212 (0.00%)  1/209 (0.48%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Quetiapine XR Quatiapine XR + Lithium
Affected / at Risk (%) Affected / at Risk (%)
Total   147/212 (69.34%)   149/209 (71.29%) 
Gastrointestinal disorders     
Constipation  1  20/212 (9.43%)  17/209 (8.13%) 
Diarrhea  1  14/212 (6.60%)  13/209 (6.22%) 
Nausea  1  14/212 (6.60%)  29/209 (13.88%) 
General disorders     
Weight gain  1  8/212 (3.77%)  11/209 (5.26%) 
Nervous system disorders     
Dry mouth  1  50/212 (23.58%)  47/209 (22.49%) 
Somnolance  1  46/212 (21.70%)  49/209 (23.44%) 
Headache  1  28/212 (13.21%)  25/209 (11.96%) 
Anxiety  1  21/212 (9.91%)  14/209 (6.70%) 
Dizziness  1  16/212 (7.55%)  32/209 (15.31%) 
Increased appetite  1  13/212 (6.13%)  5/209 (2.39%) 
Tremor  1  11/212 (5.19%)  28/209 (13.40%) 
Sedation  1  9/212 (4.25%)  11/209 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00883493     History of Changes
Other Study ID Numbers: D1443L00055
First Submitted: April 16, 2009
First Posted: April 17, 2009
Results First Submitted: February 29, 2012
Results First Posted: June 29, 2012
Last Update Posted: July 11, 2012