Generalized Anxiety Disorder Adjunct Study

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00534599
Collaborator
(none)
409
53
2
13
7.7
0.6

Study Details

Study Description

Brief Summary

This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: quetiapine fumarate XR
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
409 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Rand., Double-blind, Parallel-group, Pbo-controlled Study of the Efficacy and Safety of SEROQUEL® XR Compared With Pbo as an Adjunct to Treatment in Patients With Generalized Anxiety Disorder Who Demonstrate Partial or No Response to a SSRI or SNRI Alone or in Combination With a Benzo
Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Other: 1

Adjunctive Placebo Seroquel XR to anxiety treatment

Drug: Placebo
oral

Experimental: 2

Adjunctive Seroquel XR to anxiety treatment

Drug: quetiapine fumarate XR
oral
Other Names:
  • Seroquel XR
  • Outcome Measures

    Primary Outcome Measures

    1. Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score [Baseline (randomization) and then 8 weeks]

      Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value.

    Secondary Outcome Measures

    1. Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score [Baseline (randomization) and then 8 weeks]

      The CGI-S is assessed on a seven-point scale ranging from most extremely ill/very much worse (7) to normal/very much improved (1). Results based on MITT population with available data for this outcome measure.

    2. Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8 [Baseline (randomization) and then 8 weeks]

      This pertains to the CGI-I scale which rates improvement of anxiety on a scale from 1-7, with '1' showing the best improvement(Very Much Improved) and '7' showing the worst improvement (Very Much Worse) as compared to the baseline visit. A rating of '2' indicates 'Much Improved'. Results based on MITT population with available data for this outcome measure.

    3. Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score [Baseline (randomization) and then 8 weeks]

      The HAM-A psychic anxiety factor subscale is defined as the sum of the following 7 HAM-A factors: anxious mood, tension, fears, insomnia, intellectual, depressed mood and behavior at the interview (i.e.items 1-6 and 14, respectively) Results based on MITT population with available data for this outcome measure.

    4. Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score [Baseline (randomization) and then 8 weeks]

      The HAM-A Somatic cluster subscale is defined as the sum of the following 7 HAM-A items: somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms and autonomic system (i.e. items 7-13 respectively). Results based on MITT population with available data for this outcome measure.

    5. Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8 [Baseline (randomization) and then 8 weeks]

      Hamilton Rating Scale for Anxiety (HAM-A) response is derived from the HAM-A total score and is defined as a decrease from baseline total HAM-A score of at least 50%. (1=Yes, 0=No) Results based on MITT population with available data for this outcome measure.

    6. Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8 [Baseline (randomization) and then 8 weeks]

      Hamilton Rating Scale for Anxiety (HAM-A) remission is derived from the HAM-A total score and is defined as a HAM-A total score of ≤7. 1=Yes, 0=No Results based on MITT population with available data for this outcome measure.

    7. Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score [Baseline (randomization) and then 8 weeks]

      The Q-LES-Q score is the sum of the first 14 items, larger values indicating a higher perceived quality of life enjoyment and satisfaction. This total score was converted to a % maximum score using the following scoring conversion: %Maximum score = (Total score-14)*(100/560)rounded to an integer. Results based on MITT population with available data for this outcome measure.

    8. Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score [Baseline (randomization) and then 8 weeks]

      Results based on MITT population with available data for this outcome measure.

    9. Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score [Baseline (randomization) and then 8 weeks]

      Results based on MITT population with available data for this outcome measure.

    10. Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score [Baseline (randomization) and then 8 weeks]

      Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure.

    11. Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score [Baseline (randomization) and then 8 weeks]

      Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).Results based on MITT population with available data for this outcome measure.

    12. Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score [Baseline (randomization) and then 8 weeks]

      Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure.

    13. Least Square Mean Change From Randomization to Week 1 in CGI-S Score [Baseline (randomization) and then 8 weeks]

      Results based on MITT population with available data for this outcome measure.

    14. Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1 [Baseline (randomization) and then 8 weeks]

      Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Provision of Informed Consent

    • Documented diagnosis of Generalized Anxiety Disorder

    • Female patients must not be pregnant and be willing to use a reliable method of birth control

    • Be able to understand and comply with study requirements

    Exclusion Criteria:

    Other psychiatric disorders that could confound the study results, as judged by the study doctor

    • Moderate to severe depression

    • Other clinically relevant diseases, as judged by the study doctor

    • Medication that you are taking, as judged by the study doctor

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Birmingham Alabama United States
    2 Research Site Little Rock Arkansas United States
    3 Research Site Beverly Hills California United States
    4 Research Site Encino California United States
    5 Research Site Fresno California United States
    6 Research Site La Mesa California United States
    7 Research Site Oceanside California United States
    8 Research Site Redlands California United States
    9 Research Site San Diego California United States
    10 Research Site San Francisco California United States
    11 Research Site Sherman Oaks California United States
    12 Research Site Bradenton Florida United States
    13 Research Site Dayton Florida United States
    14 Research Site Hialeah Florida United States
    15 Research Site Jacksonville Florida United States
    16 Research Site Maitland Florida United States
    17 Research Site Miami Florida United States
    18 Research Site North Miami Florida United States
    19 Research Site Orlando Florida United States
    20 Research Site Tampa Florida United States
    21 Research Site West Palm Beach Florida United States
    22 Research Site Atlanta Georgia United States
    23 Research Site Columbus Georgia United States
    24 Research Site Chicago Illinois United States
    25 Research Site Lafayette Indiana United States
    26 Research Site Merrillville Indiana United States
    27 Research Site Terre Haute Indiana United States
    28 Research Site Prairie Village Kansas United States
    29 Research Site Owenboro Kentucky United States
    30 Research Site New Orleans Louisiana United States
    31 Research Site Rockville Maryland United States
    32 Research Site Boston Massachusetts United States
    33 Research Site Cherry Hill New Jersey United States
    34 Research Site Clementon New Jersey United States
    35 Research Site Brooklyn New York United States
    36 Research Site Cedarhurst New York United States
    37 Research Site Fresh Meadows New York United States
    38 Research Site New York New York United States
    39 Research Site Rochester New York United States
    40 Research Site Staten Island New York United States
    41 Research Site Toledo Ohio United States
    42 Research Site Oklahoma City Oklahoma United States
    43 Research Site Portland Oregon United States
    44 Research Site Salem Oregon United States
    45 Research Site Philadelphia Pennsylvania United States
    46 Research Site Memphis Tennessee United States
    47 Research Site Houston Texas United States
    48 Research Site San Antonio Texas United States
    49 Research Site Witchita Falls Texas United States
    50 Research Site Richmond Virginia United States
    51 Research Site Bellevue Washington United States
    52 Research Site Seattle Washington United States
    53 Research Site Spokane Washington United States

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Martin Brecher, MD, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00534599
    Other Study ID Numbers:
    • D1441L00016
    First Posted:
    Sep 26, 2007
    Last Update Posted:
    Apr 14, 2011
    Last Verified:
    Apr 1, 2011

    Study Results

    Participant Flow

    Recruitment Details Patient enrollment from 31 August 2007 to 02 September 2008
    Pre-assignment Detail Wash-out period of up to 35 days for discontinuation of prohibited medications
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Period Title: Overall Study
    STARTED 209 200
    COMPLETED 152 168
    NOT COMPLETED 57 32

    Baseline Characteristics

    Arm/Group Title Quetiapine XR Placebo Total
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily Total of all reporting groups
    Overall Participants 204 198 402
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    46.6
    (12.1)
    44.2
    (10.9)
    44.4
    (11.5)
    Sex: Female, Male (Count of Participants)
    Female
    146
    71.6%
    150
    75.8%
    296
    73.6%
    Male
    58
    28.4%
    48
    24.2%
    106
    26.4%

    Outcome Measures

    1. Primary Outcome
    Title Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
    Description Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    Results participant numbers are based on Modified Intention to Treat (MITT) population set; The participants in the overall study are participants randomized.
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 204 198
    Least Squares Mean (95% Confidence Interval) [units on scale]
    -10.74
    -9.61
    2. Secondary Outcome
    Title Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score
    Description The CGI-S is assessed on a seven-point scale ranging from most extremely ill/very much worse (7) to normal/very much improved (1). Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 204 198
    Least Squares Mean (95% Confidence Interval) [LS mean change from randomization]
    -1.36
    -1.13
    3. Secondary Outcome
    Title Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8
    Description This pertains to the CGI-I scale which rates improvement of anxiety on a scale from 1-7, with '1' showing the best improvement(Very Much Improved) and '7' showing the worst improvement (Very Much Worse) as compared to the baseline visit. A rating of '2' indicates 'Much Improved'. Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 204 198
    Number [Participants]
    114
    55.9%
    97
    49%
    4. Secondary Outcome
    Title Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score
    Description The HAM-A psychic anxiety factor subscale is defined as the sum of the following 7 HAM-A factors: anxious mood, tension, fears, insomnia, intellectual, depressed mood and behavior at the interview (i.e.items 1-6 and 14, respectively) Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 204 198
    Least Squares Mean (95% Confidence Interval) [LS mean change from randomization]
    -6.09
    -5.21
    5. Secondary Outcome
    Title Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score
    Description The HAM-A Somatic cluster subscale is defined as the sum of the following 7 HAM-A items: somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms and autonomic system (i.e. items 7-13 respectively). Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 204 198
    Least Squares Mean (95% Confidence Interval) [LS mean change from randomization]
    -4.63
    -4.38
    6. Secondary Outcome
    Title Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8
    Description Hamilton Rating Scale for Anxiety (HAM-A) response is derived from the HAM-A total score and is defined as a decrease from baseline total HAM-A score of at least 50%. (1=Yes, 0=No) Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 204 198
    Number [Participants]
    84
    41.2%
    72
    36.4%
    7. Secondary Outcome
    Title Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8
    Description Hamilton Rating Scale for Anxiety (HAM-A) remission is derived from the HAM-A total score and is defined as a HAM-A total score of ≤7. 1=Yes, 0=No Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 204 198
    Number [Participants]
    48
    23.5%
    34
    17.2%
    8. Secondary Outcome
    Title Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score
    Description The Q-LES-Q score is the sum of the first 14 items, larger values indicating a higher perceived quality of life enjoyment and satisfaction. This total score was converted to a % maximum score using the following scoring conversion: %Maximum score = (Total score-14)*(100/560)rounded to an integer. Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 202 194
    Least Squares Mean (95% Confidence Interval) [LS mean change from randomization]
    7.33
    6.43
    9. Secondary Outcome
    Title Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score
    Description Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 179 174
    Mean (Standard Deviation) [Mean change from randomization]
    0.30
    (1.10)
    0.40
    (1.10)
    10. Secondary Outcome
    Title Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score
    Description Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 204 198
    Mean (Standard Deviation) [Mean change from randomization]
    0.30
    (1.0)
    0.20
    (0.90)
    11. Secondary Outcome
    Title Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score
    Description Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 195 191
    Least Squares Mean (95% Confidence Interval) [LS mean change from randomization]
    -6.45
    -4.47
    12. Secondary Outcome
    Title Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score
    Description Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 195 191
    Least Squares Mean (95% Confidence Interval) [LS mean change from randomization]
    -3.70
    -2.46
    13. Secondary Outcome
    Title Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score
    Description Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 195 191
    Least Squares Mean (95% Confidence Interval) [LS mean change from randomization]
    -2.74
    -2.0
    14. Secondary Outcome
    Title Least Square Mean Change From Randomization to Week 1 in CGI-S Score
    Description Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 195 191
    Least Squares Mean (95% Confidence Interval) [LS mean change from randomization]
    -0.56
    -0.35
    15. Secondary Outcome
    Title Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1
    Description Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure.
    Time Frame Baseline (randomization) and then 8 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    Measure Participants 195 191
    Number [Participants]
    33
    16.2%
    22
    11.1%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Quetiapine XR Placebo
    Arm/Group Description 50 mg to 300 mg extended release tablets once daily Matching placebo tablets once daily
    All Cause Mortality
    Quetiapine XR Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Quetiapine XR Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/209 (0%) 0/200 (0%)
    Other (Not Including Serious) Adverse Events
    Quetiapine XR Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 154/209 (73.7%) 120/200 (60%)
    Blood and lymphatic system disorders
    Anaemia 0/209 (0%) 1/200 (0.5%)
    Cardiac disorders
    Palpitations 3/209 (1.4%) 1/200 (0.5%)
    Sinus Arrhythmia 0/209 (0%) 1/200 (0.5%)
    Supraventricular Extrasystoles 1/209 (0.5%) 0/200 (0%)
    Ear and labyrinth disorders
    Tinnitus 2/209 (1%) 1/200 (0.5%)
    Vertigo 1/209 (0.5%) 1/200 (0.5%)
    Eye disorders
    Blepharitis 0/209 (0%) 1/200 (0.5%)
    Blepharospasm 1/209 (0.5%) 0/200 (0%)
    Conjunctivitis 2/209 (1%) 0/200 (0%)
    Dry Eye 0/209 (0%) 1/200 (0.5%)
    Vision Blurred 2/209 (1%) 0/200 (0%)
    Gastrointestinal disorders
    Abdominal Discomfort 1/209 (0.5%) 0/200 (0%)
    Abdominal Distension 2/209 (1%) 0/200 (0%)
    Abdominal Pain 2/209 (1%) 1/200 (0.5%)
    Abdominal Pain Upper 2/209 (1%) 2/200 (1%)
    Abnormal Faeces 1/209 (0.5%) 0/200 (0%)
    Constipation 13/209 (6.2%) 8/200 (4%)
    Diarrhoea 6/209 (2.9%) 6/200 (3%)
    Dry Mouth 49/209 (23.4%) 16/200 (8%)
    Dyspepsia 6/209 (2.9%) 3/200 (1.5%)
    Flatulence 1/209 (0.5%) 1/200 (0.5%)
    Gastrooesophageal Reflux Disease 2/209 (1%) 0/200 (0%)
    Haematochezia 1/209 (0.5%) 0/200 (0%)
    Nausea 12/209 (5.7%) 12/200 (6%)
    Stomach Discomfort 2/209 (1%) 0/200 (0%)
    Toothache 1/209 (0.5%) 1/200 (0.5%)
    Vomiting 3/209 (1.4%) 3/200 (1.5%)
    General disorders
    Chest Discomfort 1/209 (0.5%) 2/200 (1%)
    Chest Pain 2/209 (1%) 0/200 (0%)
    Fatigue 20/209 (9.6%) 8/200 (4%)
    Gait Disturbance 1/209 (0.5%) 0/200 (0%)
    Irritability 4/209 (1.9%) 1/200 (0.5%)
    Malaise 1/209 (0.5%) 0/200 (0%)
    Oedema 0/209 (0%) 1/200 (0.5%)
    Pyrexia 1/209 (0.5%) 0/200 (0%)
    Sluggishness 1/209 (0.5%) 0/200 (0%)
    Thirst 0/209 (0%) 1/200 (0.5%)
    Immune system disorders
    Hypersensitivity 0/209 (0%) 1/200 (0.5%)
    Seasonal Allergy 3/209 (1.4%) 0/200 (0%)
    Infections and infestations
    Breast Infection 1/209 (0.5%) 0/200 (0%)
    Bronchitis 1/209 (0.5%) 0/200 (0%)
    Conjunctivitis Infective 0/209 (0%) 1/200 (0.5%)
    Cystitis 1/209 (0.5%) 0/200 (0%)
    Enterobiasis 1/209 (0.5%) 0/200 (0%)
    Gastroenteritis Viral 0/209 (0%) 1/200 (0.5%)
    Herpes Zoster 1/209 (0.5%) 0/200 (0%)
    Influenza 4/209 (1.9%) 2/200 (1%)
    Lower Respiratory Tract Infection 0/209 (0%) 1/200 (0.5%)
    Nasopharyngitis 7/209 (3.3%) 17/200 (8.5%)
    Otitis Externa 1/209 (0.5%) 0/200 (0%)
    Pharyngitis 1/209 (0.5%) 0/200 (0%)
    Respiratory Tract Infection 1/209 (0.5%) 1/200 (0.5%)
    Rhinovirus Infection 1/209 (0.5%) 0/200 (0%)
    Sinusitis 5/209 (2.4%) 4/200 (2%)
    Tooth Abscess 1/209 (0.5%) 1/200 (0.5%)
    Upper Respiratory Tract Infection 8/209 (3.8%) 5/200 (2.5%)
    Urinary Tract Infection 4/209 (1.9%) 2/200 (1%)
    Viral Infection 1/209 (0.5%) 1/200 (0.5%)
    Injury, poisoning and procedural complications
    Joint Sprain 0/209 (0%) 1/200 (0.5%)
    Road Traffic Accident 1/209 (0.5%) 0/200 (0%)
    Thermal Burn 0/209 (0%) 1/200 (0.5%)
    Wound 0/209 (0%) 1/200 (0.5%)
    Blood Cholesterol Increased 1/209 (0.5%) 0/200 (0%)
    Blood Prolactin Increased 0/209 (0%) 1/200 (0.5%)
    Blood Triglycerides Increased 1/209 (0.5%) 0/200 (0%)
    Electrocardiogram QT Prolonged 1/209 (0.5%) 0/200 (0%)
    Electrocardiogram T Wave Amplitude Decreased 1/209 (0.5%) 0/200 (0%)
    Glycosylated Haemoglobin Increased 1/209 (0.5%) 1/200 (0.5%)
    Lipids Increased 1/209 (0.5%) 0/200 (0%)
    Neutrophil Count Decreased 1/209 (0.5%) 0/200 (0%)
    Weight Decreased 0/209 (0%) 2/200 (1%)
    Weight Increased 8/209 (3.8%) 2/200 (1%)
    White Blood Cell Count Decreased 1/209 (0.5%) 0/200 (0%)
    Metabolism and nutrition disorders
    Dehydration 1/209 (0.5%) 0/200 (0%)
    Dyslipidaemia 0/209 (0%) 1/200 (0.5%)
    Glucose Tolerance Impaired 1/209 (0.5%) 0/200 (0%)
    Hyperlipidaemia 1/209 (0.5%) 0/200 (0%)
    Increased Appetite 8/209 (3.8%) 1/200 (0.5%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/209 (0.5%) 2/200 (1%)
    Back Pain 4/209 (1.9%) 4/200 (2%)
    Contusion 0/209 (0%) 1/200 (0.5%)
    Joint Effusion 0/209 (0%) 1/200 (0.5%)
    Joint Stiffness 1/209 (0.5%) 0/200 (0%)
    Muscle Contracture 0/209 (0%) 2/200 (1%)
    Muscle Spasms 2/209 (1%) 5/200 (2.5%)
    Muscle Tightness 2/209 (1%) 1/200 (0.5%)
    Muscle Twitching 1/209 (0.5%) 1/200 (0.5%)
    Musculoskeletal Pain 0/209 (0%) 2/200 (1%)
    Musculoskeletal Stiffness 4/209 (1.9%) 0/200 (0%)
    Myalgia 3/209 (1.4%) 2/200 (1%)
    Neck Pain 3/209 (1.4%) 0/200 (0%)
    Pain In Extremity 1/209 (0.5%) 1/200 (0.5%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibroma 1/209 (0.5%) 0/200 (0%)
    Uterine Leiomyoma 0/209 (0%) 1/200 (0.5%)
    Nervous system disorders
    Akathisia 0/209 (0%) 1/200 (0.5%)
    Amnesia 1/209 (0.5%) 0/200 (0%)
    Balance Disorder 1/209 (0.5%) 0/200 (0%)
    Disturbance In Attention 1/209 (0.5%) 0/200 (0%)
    Dizziness 22/209 (10.5%) 9/200 (4.5%)
    Dysarthria 1/209 (0.5%) 0/200 (0%)
    Dysgeusia 2/209 (1%) 0/200 (0%)
    Headache 24/209 (11.5%) 21/200 (10.5%)
    Hypersomnia 2/209 (1%) 0/200 (0%)
    Hypoaesthesia 2/209 (1%) 1/200 (0.5%)
    Lethargy 3/209 (1.4%) 0/200 (0%)
    Migraine 0/209 (0%) 1/200 (0.5%)
    Paraesthesia 5/209 (2.4%) 1/200 (0.5%)
    Psychomotor Hyperactivity 2/209 (1%) 1/200 (0.5%)
    Restless Legs Syndrome 2/209 (1%) 0/200 (0%)
    Sedation 26/209 (12.4%) 5/200 (2.5%)
    Somnolence 47/209 (22.5%) 24/200 (12%)
    Speech Disorder 0/209 (0%) 1/200 (0.5%)
    Tension Headache 2/209 (1%) 0/200 (0%)
    Tremor 3/209 (1.4%) 1/200 (0.5%)
    Psychiatric disorders
    Abnormal Dreams 6/209 (2.9%) 2/200 (1%)
    Agitation 2/209 (1%) 0/200 (0%)
    Anxiety 1/209 (0.5%) 1/200 (0.5%)
    Confusional State 1/209 (0.5%) 0/200 (0%)
    Crying 1/209 (0.5%) 0/200 (0%)
    Depressed Mood 1/209 (0.5%) 0/200 (0%)
    Depression 3/209 (1.4%) 3/200 (1.5%)
    Generalised Anxiety Disorder 0/209 (0%) 2/200 (1%)
    Initial Insomnia 1/209 (0.5%) 0/200 (0%)
    Insomnia 15/209 (7.2%) 3/200 (1.5%)
    Libido Decreased 5/209 (2.4%) 0/200 (0%)
    Nightmare 2/209 (1%) 1/200 (0.5%)
    Restlessness 3/209 (1.4%) 1/200 (0.5%)
    Sleep Disorder 2/209 (1%) 0/200 (0%)
    Renal and urinary disorders
    Dysuria 1/209 (0.5%) 0/200 (0%)
    Reproductive system and breast disorders
    Amenorrhoea 1/209 (0.5%) 0/200 (0%)
    Ejaculation Delayed 1/209 (0.5%) 0/200 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 2/209 (1%) 1/200 (0.5%)
    Dyspnoea 3/209 (1.4%) 0/200 (0%)
    Epistaxis 1/209 (0.5%) 0/200 (0%)
    Nasal Congestion 1/209 (0.5%) 0/200 (0%)
    Pharyngolaryngeal Pain 0/209 (0%) 3/200 (1.5%)
    Sinus Disorder 1/209 (0.5%) 0/200 (0%)
    Skin and subcutaneous tissue disorders
    Acne 2/209 (1%) 1/200 (0.5%)
    Dermatitis Contact 1/209 (0.5%) 0/200 (0%)
    Night Sweats 0/209 (0%) 1/200 (0.5%)
    Rash Pruritic 0/209 (0%) 1/200 (0.5%)
    Urticaria 1/209 (0.5%) 0/200 (0%)
    Vascular disorders
    Sebaceous Cyst Excision 1/209 (0.5%) 0/200 (0%)
    Hot Flush 0/209 (0%) 1/200 (0.5%)
    Hypertension 2/209 (1%) 1/200 (0.5%)
    Orthostatic Hypotension 1/209 (0.5%) 0/200 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    If Sponsor does not publish within 2 years after study completion, PI is permitted to publish, with confidential information removed from manuscript. Sponsor will have opportunity to review and approve publication at least 60 days prior to being submitted/disclosed. Sponsor can request, in writing, an additional 90 day embargo.

    Results Point of Contact

    Name/Title Gerard Lynch
    Organization AstraZeneca
    Phone
    Email AZtrial_results_posting@astrazeneca.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00534599
    Other Study ID Numbers:
    • D1441L00016
    First Posted:
    Sep 26, 2007
    Last Update Posted:
    Apr 14, 2011
    Last Verified:
    Apr 1, 2011