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Trial record 13 of 19 for:    TC-5214

A Study to Assess the Long- Term Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

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: NCT01152554
Recruitment Status : Completed
First Posted : June 29, 2010
Results First Posted : October 29, 2012
Last Update Posted : April 11, 2014
Sponsor:
Collaborator:
Targacept Inc.
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Major Depressive Disorder
MDD
Depression
Interventions Drug: TC-5214
Drug: Placebo
Enrollment 813
Recruitment Details This multicenter study was conducted in the US between 22 June 2010 and 07 February 2012.
Pre-assignment Details The study had an up to 21-day screening/washout period, and an 6-week prospective open-label antidepressant treatment (ADT) period to identify the target patient population of inadequate responders to ADT (a HAMD-17 total score of ≥10 and a CGI-S score ≥3).
Arm/Group Title TC-5214 Placebo
Hide Arm/Group Description Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Period Title: Overall Study
Started 610 203
Received Treatment 607 201
Completed 276 92
Not Completed 334 111
Reason Not Completed
Withdrawal by Subject             73             28
Eligiblity criteria not fulfilled             0             1
Adverse Event             67             14
Severe non-compliance to protocol             36             14
Condition under investigation worsened             5             2
Lack of Efficacy             20             3
Study-specific withdrawal criteria             17             8
Lost to Follow-up             87             32
Not specified             28             8
Death             1             1
Arm/Group Title TC-5214 Placebo Total
Hide Arm/Group Description Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID Total of all reporting groups
Overall Number of Baseline Participants 610 203 813
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 610 participants 203 participants 813 participants
43.2  (11.68) 42.8  (11.75) 43.1  (11.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 610 participants 203 participants 813 participants
Female
418
  68.5%
148
  72.9%
566
  69.6%
Male
192
  31.5%
55
  27.1%
247
  30.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 610 participants 203 participants 813 participants
White 467 149 616
Black or African American 121 44 165
Asian 10 4 14
Native Hawaiian or other Pacific Islander 1 0 1
American Indian or Alaska Native 0 2 2
Other 11 4 15
Hamilton Rating Scale for Depression-17 items (HAMD-17) total score at randomization   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 610 participants 203 participants 813 participants
18.4  (4.49) 18.6  (4.61) 18.5  (4.52)
[1]
Measure Description: A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.
Montgomery-Asberg Depression Rating Scale (MADRS) total score at randomization   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 610 participants 203 participants 813 participants
23.5  (6.34) 23.4  (5.85) 23.4  (6.21)
[1]
Measure Description: A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.
1.Primary Outcome
Title Frequency of Patients Experiencing at Least One Adverse Event (AE)
Hide Description The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated.
Time Frame Randomization (Week 0) to end of the follow-up period (Week 54)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.
Arm/Group Title TC-5214 Placebo
Hide Arm/Group Description:
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Overall Number of Participants Analyzed 607 201
Measure Type: Number
Unit of Measure: percentage of participants analyzed
82.4 84.6
2.Primary Outcome
Title Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
Hide Description The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
Time Frame Randomization (Week 0) to end of the follow-up period (Week 54)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.
Arm/Group Title TC-5214 Placebo
Hide Arm/Group Description:
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Overall Number of Participants Analyzed 607 201
Measure Type: Number
Unit of Measure: percentage of participants analyzed
10.5 7.0
3.Primary Outcome
Title Frequency of Patients Experiencing Serious Adverse Events (SAEs)
Hide Description The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated.
Time Frame Randomization (Week 0) to end of the follow-up period (Week 54)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and for whom any postdose data were available.
Arm/Group Title TC-5214 Placebo
Hide Arm/Group Description:
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Overall Number of Participants Analyzed 607 201
Measure Type: Number
Unit of Measure: percentage of participants analyzed
3.6 2.5
4.Secondary Outcome
Title Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤12 at Week 12 and All Visits up to and Including Week 24
Hide Description

The percentage of patients with a a MADRS total score of ≤12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score >12 but ≤16 or missing was allowed from Week 16 to Week 20.

A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.

Time Frame Week 12 to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.
Arm/Group Title TC-5214 Placebo
Hide Arm/Group Description:
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Overall Number of Participants Analyzed 391 136
Measure Type: Number
Unit of Measure: percentage of participants analyzed
18.2 20.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TC-5214, Placebo
Comments Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.697
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.54 to 1.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.24
Estimation Comments TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.
5.Secondary Outcome
Title Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of ≤12 at Week 12 and at All Visits up to and Including Week 52
Hide Description

The percentage of patients with a MADRS total score of ≤12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS >12 but ≤16 or missing were allowed from Week 16 to Week 48.

A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.

Time Frame Week 12 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.
Arm/Group Title TC-5214 Placebo
Hide Arm/Group Description:
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Overall Number of Participants Analyzed 391 136
Measure Type: Number
Unit of Measure: percentage of patients analyzed
9.7 12.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TC-5214, Placebo
Comments Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.582
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.45 to 1.57
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.27
Estimation Comments TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.
6.Secondary Outcome
Title Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 0) to End of Treatment (Week 52)
Hide Description A 3-part, clinician-administered scale that rates the improvement or worsening of the patient’s illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.
Time Frame Randomization (Week 0) to end of treatment (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.
Arm/Group Title TC-5214 Placebo
Hide Arm/Group Description:
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Overall Number of Participants Analyzed 176 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.8  (1.17) -1.6  (1.17)
7.Secondary Outcome
Title Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) as Measured by the Sheehan Disability Scale (SDS) Total Score
Hide Description Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).
Time Frame Randomization (Week 0) to end of treatment (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.
Arm/Group Title TC-5214 Placebo
Hide Arm/Group Description:
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Overall Number of Participants Analyzed 185 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.98  (7.909) -7.44  (7.530)
8.Secondary Outcome
Title Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score
Hide Description The Q-LES-Q-SF total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score – 14) / 56, and can range from 0% to 100%.
Time Frame Randomization (Week 0) to end of treatment (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.
Arm/Group Title TC-5214 Placebo
Hide Arm/Group Description:
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Overall Number of Participants Analyzed 184 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.83  (18.744) 11.62  (17.006)
9.Secondary Outcome
Title Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52)
Hide Description A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.
Time Frame Randomization (Week 0) to end of treatment (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat analysis set including all randomized patients who received at least 1 dose of investigational product (TC-5214 or placebo) and who had a total MADRS score at randomization and a total HAMD-17 score ≥16 and a CGI-S score ≥4 at randomization.
Arm/Group Title TC-5214 Placebo
Hide Arm/Group Description:
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Overall Number of Participants Analyzed 177 68
Mean (Standard Deviation)
Unit of Measure: units on a scale
EQ-5D index score 0.081  (0.2021) 0.071  (0.1500)
EQ-5D VAS score 8.7  (20.04) 11.9  (21.06)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo TC-5214
Hide Arm/Group Description Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
All-Cause Mortality
Placebo TC-5214
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo TC-5214
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/201 (2.49%)      22/607 (3.62%)    
Cardiac disorders     
Bradycardia  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Gastrointestinal disorders     
Abdominal Hernia  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Diverticulum  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Haemorrhoids  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Small Intestinal Obstruction  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Infections and infestations     
Cellulitis  1  0/201 (0.00%)  0 2/607 (0.33%)  2
Oral Infection  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Pneumonia  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Injury, poisoning and procedural complications     
Brain Contusion  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Cervical Vertebral Fracture  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Contusion  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Facial Bones Fracture  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Fibula Fracture  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Intentional Overdose  1  1/201 (0.50%)  1 0/607 (0.00%)  0
Tibia Fracture  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Toxicity To Various Agents  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Metabolism and nutrition disorders     
Diabetic Ketoacidosis  1  1/201 (0.50%)  1 0/607 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal Chest Pain  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Nervous system disorders     
Subarachnoid Haemorrhage  1  1/201 (0.50%)  1 0/607 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion Spontaneous  1  1/201 (0.50%)  1 1/607 (0.16%)  1
Psychiatric disorders     
Alcohol Withdrawal Syndrome  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Psychotic Disorder  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Suicidal Ideation  1  0/201 (0.00%)  0 2/607 (0.33%)  2
Suicide Attempt  1  0/201 (0.00%)  0 2/607 (0.33%)  2
Reproductive system and breast disorders     
Ovarian Torsion  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Vaginal Haemorrhage  1  1/201 (0.50%)  1 0/607 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  1/201 (0.50%)  1 0/607 (0.00%)  0
Vascular disorders     
Hypertensive Crisis  1  0/201 (0.00%)  0 1/607 (0.16%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo TC-5214
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   151/201 (75.12%)      451/607 (74.30%)    
Gastrointestinal disorders     
Constipation  1  12/201 (5.97%)  14 120/607 (19.77%)  147
Diarrhoea  1  20/201 (9.95%)  23 65/607 (10.71%)  80
Nausea  1  24/201 (11.94%)  27 64/607 (10.54%)  79
Dry Mouth  1  10/201 (4.98%)  11 59/607 (9.72%)  61
Vomiting  1  13/201 (6.47%)  21 32/607 (5.27%)  40
Abdominal Pain  1  4/201 (1.99%)  4 12/607 (1.98%)  12
Abdominal Pain Upper  1  2/201 (1.00%)  2 14/607 (2.31%)  16
Flatulence  1  4/201 (1.99%)  4 14/607 (2.31%)  15
Abdominal Distension  1  4/201 (1.99%)  5 5/607 (0.82%)  5
General disorders     
Fatigue  1  17/201 (8.46%)  18 39/607 (6.43%)  43
Immune system disorders     
Seasonal Allergy  1  5/201 (2.49%)  5 11/607 (1.81%)  12
Infections and infestations     
Upper Respiratory Tract Infection  1  30/201 (14.93%)  39 104/607 (17.13%)  122
Nasopharyngitis  1  22/201 (10.95%)  26 59/607 (9.72%)  70
Sinusitis  1  11/201 (5.47%)  14 28/607 (4.61%)  32
Urinary Tract Infection  1  10/201 (4.98%)  11 26/607 (4.28%)  30
Influenza  1  7/201 (3.48%)  8 19/607 (3.13%)  22
Bronchitis  1  5/201 (2.49%)  5 12/607 (1.98%)  12
Gastroenteritis  1  5/201 (2.49%)  6 14/607 (2.31%)  14
Gastroenteritis Viral  1  5/201 (2.49%)  5 13/607 (2.14%)  13
Injury, poisoning and procedural complications     
Contusion  1  6/201 (2.99%)  6 5/607 (0.82%)  5
Muscle Strain  1  4/201 (1.99%)  4 7/607 (1.15%)  7
Weight Increased  1  14/201 (6.97%)  14 27/607 (4.45%)  27
Blood Pressure Increased  1  5/201 (2.49%)  6 8/607 (1.32%)  9
Metabolism and nutrition disorders     
Increased Appetite  1  5/201 (2.49%)  5 11/607 (1.81%)  13
Musculoskeletal and connective tissue disorders     
Arthralgia  1  10/201 (4.98%)  12 26/607 (4.28%)  35
Back Pain  1  18/201 (8.96%)  21 20/607 (3.29%)  23
Muscle Spasms  1  5/201 (2.49%)  5 15/607 (2.47%)  16
Musculoskeletal Pain  1  6/201 (2.99%)  7 13/607 (2.14%)  13
Neck Pain  1  4/201 (1.99%)  4 11/607 (1.81%)  11
Pain In Extremity  1  4/201 (1.99%)  5 11/607 (1.81%)  11
Myalgia  1  7/201 (3.48%)  8 9/607 (1.48%)  11
Nervous system disorders     
Headache  1  34/201 (16.92%)  52 102/607 (16.80%)  170
Dizziness  1  16/201 (7.96%)  24 75/607 (12.36%)  99
Dizziness Postural  1  3/201 (1.49%)  3 28/607 (4.61%)  43
Somnolence  1  9/201 (4.48%)  9 31/607 (5.11%)  33
Sedation  1  4/201 (1.99%)  4 12/607 (1.98%)  12
Memory Impairment  1  4/201 (1.99%)  4 5/607 (0.82%)  6
Migraine  1  5/201 (2.49%)  5 8/607 (1.32%)  8
Paraesthesia  1  5/201 (2.49%)  6 7/607 (1.15%)  7
Tremor  1  4/201 (1.99%)  4 5/607 (0.82%)  5
Psychiatric disorders     
Insomnia  1  18/201 (8.96%)  20 47/607 (7.74%)  52
Abnormal Dreams  1  7/201 (3.48%)  7 28/607 (4.61%)  29
Agitation  1  5/201 (2.49%)  6 21/607 (3.46%)  22
Anxiety  1  1/201 (0.50%)  1 15/607 (2.47%)  17
Bruxism  1  4/201 (1.99%)  4 3/607 (0.49%)  3
Respiratory, thoracic and mediastinal disorders     
Cough  1  5/201 (2.49%)  5 15/607 (2.47%)  15
Nasal Congestion  1  4/201 (1.99%)  5 11/607 (1.81%)  12
Oropharyngeal Pain  1  5/201 (2.49%)  5 13/607 (2.14%)  13
Wheezing  1  4/201 (1.99%)  4 1/607 (0.16%)  1
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  5/201 (2.49%)  5 17/607 (2.80%)  19
Rash  1  4/201 (1.99%)  4 6/607 (0.99%)  6
Vascular disorders     
Hypertension  1  9/201 (4.48%)  9 15/607 (2.47%)  15
Orthostatic Hypotension  1  0/201 (0.00%)  0 13/607 (2.14%)  15
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01152554     History of Changes
Other Study ID Numbers: D4130C00007
First Submitted: June 28, 2010
First Posted: June 29, 2010
Results First Submitted: June 26, 2012
Results First Posted: October 29, 2012
Last Update Posted: April 11, 2014