Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Assess the Safety and Effect of TC-5214 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: NCT01288079
Recruitment Status : Terminated
First Posted : February 2, 2011
Results First Posted : October 29, 2012
Last Update Posted : November 20, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: TC-5214
Drug: Duloxetine
Drug: Placebo
Enrollment 145
Recruitment Details This multicenter study was conducted in Europe, Asia, and North America between 4 February 2011 and 26 April 2012.
Pre-assignment Details 21-day screening/washout and 8-week prospective open-label SSRI(selective serotonin reuptake inhibitors)/SNRI(selective serotonin and norepinephrine reuptake inhibitors) periods to identify population of inadequate responders(<50% reduction in Hamilton Rating Scale for Depression total score of ≥16 and a Clinical Global Impression-Severity ≥4).
Arm/Group Title 1 mg BID TC-5214 4 mg BID TC-5214 60 mg QD Duloxetine Placebo
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 37 36 37 35
Completed 17 9 18 18
Not Completed 20 27 19 17
Reason Not Completed
Withdrawal by Subject             2             4             1             0
Adverse Event             2             1             2             3
Severe Non-Compliance to Protocol             1             3             1             3
Condition under Investigation Worsened             0             0             0             1
Lack of Efficacy             2             2             0             2
Study-Specific Withdrawal Criteria             1             1             0             0
Lost to Follow-up             1             1             1             0
Other or Study Termination             11             15             14             8
Arm/Group Title 1 mg BID TC-5214 4 mg BID TC-5214 60 mg QD Duloxetine Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 37 36 37 35 145
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 36 participants 37 participants 35 participants 145 participants
44.5  (13.03) 40.3  (12.50) 41.8  (12.70) 40.1  (10.49) 41.7  (12.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 36 participants 37 participants 35 participants 145 participants
Female
24
  64.9%
26
  72.2%
22
  59.5%
19
  54.3%
91
  62.8%
Male
13
  35.1%
10
  27.8%
15
  40.5%
16
  45.7%
54
  37.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 36 participants 37 participants 35 participants 145 participants
White 23 20 23 20 86
Black or African American 1 4 4 5 14
Asian 12 10 9 9 40
Native Hawaiian or other Pacific Islander 0 0 0 0 0
American Indian or Alaska Native 0 0 0 0 0
Other 1 2 1 1 5
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 37 participants 36 participants 37 participants 35 participants 145 participants
20.914  (3.425) 21.371  (3.606) 21.857  (3.499) 21.344  (4.100) 21.372  (3.632)
[1]
Measure Description: A 17-item, clinician-rated scale that assesses depressive symptoms. The Hamilton Rating Scale for Depression-17 items (HAMD-17) consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. 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 37 participants 36 participants 37 participants 35 participants 145 participants
27.228  (5.202) 26.857  (5.542) 28.600  (6.796) 27.625  (5.320) 27.577  (5.734)
[1]
Measure Description: A 10-item scale for the evaluation of depressive symptoms. Each Montgomery-Asberg Depression Rating Scale (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 Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment
Hide Description A 10-item scale for the evaluation of depressive symptoms. Each Montgomery Asberg Depression Rating Scale (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 Randomization (Week 8) to end of treatment (Week 16)
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, duloxetine or placebo) and who had a randomization and at least 1 post-randomization MADRS total score.
Arm/Group Title 1 mg BID TC-5214 4 mg BID TC-5214 60 mg QD Duloxetine Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 35 35 35 32
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.1  (2.15) -11.2  (2.56) -11.4  (2.14) -7.6  (2.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 mg BID TC-5214, Placebo
Comments Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.617
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-7.35 to 4.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.95
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 4 mg BID TC-5214, Placebo
Comments Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.277
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-10.06 to 2.91
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 60 mg QD Duloxetine, Placebo
Comments Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.194
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-9.72 to 2.00
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.95
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 mg BID TC-5214 4 mg BID TC-5214 60 mg QD Duloxetine Placebo
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
1 mg BID TC-5214 4 mg BID TC-5214 60 mg QD Duloxetine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1 mg BID TC-5214 4 mg BID TC-5214 60 mg QD Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/37 (2.70%)      0/35 (0.00%)      0/37 (0.00%)      1/35 (2.86%)    
Gastrointestinal disorders         
Abdominal Pain  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Infections and infestations         
Subcutaneous Abscess  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
1 mg BID TC-5214 4 mg BID TC-5214 60 mg QD Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/37 (59.46%)      27/35 (77.14%)      21/37 (56.76%)      24/35 (68.57%)    
Blood and lymphatic system disorders         
Anaemia Megaloblastic  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Eosinophilia  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Leukopenia  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Neutropenia  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Ear and labyrinth disorders         
Tinnitus  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Eye disorders         
Vision Blurred  1  0/37 (0.00%)  0 2/35 (5.71%)  2 0/37 (0.00%)  0 0/35 (0.00%)  0
Eye Pain  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Visual Impairment  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  2 1/35 (2.86%)  1
Gastrointestinal disorders         
Constipation  1  0/37 (0.00%)  0 9/35 (25.71%)  9 2/37 (5.41%)  2 2/35 (5.71%)  2
Nausea  1  4/37 (10.81%)  4 3/35 (8.57%)  3 7/37 (18.92%)  9 2/35 (5.71%)  2
Diarrhoea  1  1/37 (2.70%)  1 3/35 (8.57%)  3 1/37 (2.70%)  1 3/35 (8.57%)  3
Abdominal Pain  1  2/37 (5.41%)  2 2/35 (5.71%)  2 0/37 (0.00%)  0 1/35 (2.86%)  1
Dry Mouth  1  0/37 (0.00%)  0 2/35 (5.71%)  2 1/37 (2.70%)  1 0/35 (0.00%)  0
Abdominal Pain Upper  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  2
Dental Caries  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Dyspepsia  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 1/35 (2.86%)  4
Flatulence  1  1/37 (2.70%)  1 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Toothache  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Vomiting  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
General disorders         
Asthenia  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Drug Withdrawal Syndrome  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Fatigue  1  0/37 (0.00%)  0 1/35 (2.86%)  1 1/37 (2.70%)  1 0/35 (0.00%)  0
Feeling Abnormal  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Feeling Cold  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Pyrexia  1  1/37 (2.70%)  1 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Thirst  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Hepatobiliary disorders         
Hepatic Function Abnormal  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Immune system disorders         
Seasonal Allergy  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Infections and infestations         
Influenza  1  1/37 (2.70%)  1 1/35 (2.86%)  1 2/37 (5.41%)  2 4/35 (11.43%)  4
Nasopharyngitis  1  3/37 (8.11%)  3 2/35 (5.71%)  2 0/37 (0.00%)  0 3/35 (8.57%)  3
Urinary Tract Infection  1  0/37 (0.00%)  0 2/35 (5.71%)  3 1/37 (2.70%)  1 1/35 (2.86%)  1
Bronchitis  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Gastroenteritis  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Hordeolum  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Tooth Infection  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Upper Respiratory Tract Infection  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Urethritis  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Injury, poisoning and procedural complications         
Procedural Dizziness  1  1/37 (2.70%)  4 0/35 (0.00%)  0 2/37 (5.41%)  5 0/35 (0.00%)  0
Fall  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Limb Injury  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Blood Pressure Increased  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 2/35 (5.71%)  2
Heart Rate Increased  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Weight Decreased  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Weight Increased  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 1/35 (2.86%)  1
Metabolism and nutrition disorders         
Increased Appetite  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 3/35 (8.57%)  3
Decreased Appetite  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 2/35 (5.71%)  2
Dyslipidaemia  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Folate Deficiency  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back Pain  1  1/37 (2.70%)  1 0/35 (0.00%)  0 3/37 (8.11%)  3 0/35 (0.00%)  0
Pain In Extremity  1  0/37 (0.00%)  0 0/35 (0.00%)  0 2/37 (5.41%)  2 0/35 (0.00%)  0
Arthralgia  1  1/37 (2.70%)  1 1/35 (2.86%)  2 0/37 (0.00%)  0 0/35 (0.00%)  0
Joint Swelling  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Muscle Spasms  1  0/37 (0.00%)  0 1/35 (2.86%)  1 1/37 (2.70%)  1 0/35 (0.00%)  0
Myalgia  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 1/35 (2.86%)  1
Neck Pain  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Pain In Jaw  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Nervous system disorders         
Dizziness  1  6/37 (16.22%)  6 4/35 (11.43%)  4 5/37 (13.51%)  8 6/35 (17.14%)  8
Headache  1  4/37 (10.81%)  5 6/35 (17.14%)  6 3/37 (8.11%)  8 5/35 (14.29%)  8
Somnolence  1  2/37 (5.41%)  2 1/35 (2.86%)  1 4/37 (10.81%)  5 0/35 (0.00%)  0
Dizziness Postural  1  1/37 (2.70%)  1 0/35 (0.00%)  0 1/37 (2.70%)  1 3/35 (8.57%)  8
Balance Disorder  1  0/37 (0.00%)  0 0/35 (0.00%)  0 2/37 (5.41%)  2 1/35 (2.86%)  3
Paraesthesia  1  2/37 (5.41%)  2 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Disturbance In Attention  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Dysgeusia  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Formication  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Head Discomfort  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  2
Hypoaesthesia  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Memory Impairment  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Stupor  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Tremor  1  1/37 (2.70%)  1 1/35 (2.86%)  1 1/37 (2.70%)  1 1/35 (2.86%)  1
Psychiatric disorders         
Insomnia  1  0/37 (0.00%)  0 3/35 (8.57%)  3 4/37 (10.81%)  4 2/35 (5.71%)  2
Agitation  1  0/37 (0.00%)  0 1/35 (2.86%)  1 1/37 (2.70%)  1 2/35 (5.71%)  2
Nightmare  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 2/35 (5.71%)  2
Suicidal Ideation  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 2/35 (5.71%)  2
Abnormal Dreams  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 1/35 (2.86%)  1
Anxiety  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Bradyphrenia  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Confusional State  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Dissociation  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Hypervigilance  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Intentional Self-Injury  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Libido Decreased  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Mood Swings  1  0/37 (0.00%)  0 0/35 (0.00%)  0 0/37 (0.00%)  0 1/35 (2.86%)  1
Sleep Disorder  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Tension  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Renal and urinary disorders         
Nocturia  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Pollakiuria  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 1/35 (2.86%)  1
Urinary Retention  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Reproductive system and breast disorders         
Uterine Polyp  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  2/37 (5.41%)  2 1/35 (2.86%)  1 1/37 (2.70%)  1 0/35 (0.00%)  0
Night Sweats  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Rash  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Urticaria  1  0/37 (0.00%)  0 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Vascular disorders         
Hypertension  1  1/37 (2.70%)  1 0/35 (0.00%)  0 0/37 (0.00%)  0 0/35 (0.00%)  0
Orthostatic Hypotension  1  1/37 (2.70%)  1 1/35 (2.86%)  1 0/37 (0.00%)  0 0/35 (0.00%)  0
Varicose Vein  1  0/37 (0.00%)  0 0/35 (0.00%)  0 1/37 (2.70%)  1 0/35 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
The study was terminated early and thus only a fraction of the planned number of patients were randomized and many did not complete the study. As a consequence the possibility of interpreting efficacy over an 8 week period is considerably reduced.
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: NCT01288079     History of Changes
Other Study ID Numbers: D4131C00001
First Submitted: January 26, 2011
First Posted: February 2, 2011
Results First Submitted: August 7, 2012
Results First Posted: October 29, 2012
Last Update Posted: November 20, 2012