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Trial record 5 of 544 for:    Argentina | Bulgaria

Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA) (Oberon)

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: NCT00441727
Recruitment Status : Completed
First Posted : March 1, 2007
Results First Posted : February 13, 2012
Last Update Posted : July 16, 2012
Sponsor:
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: Prevention
Conditions Gastric Ulcer
Duodenal Ulcer
Interventions Drug: Esomeprazole 40 mg
Drug: Esomeprazole 20 mg
Drug: Placebo
Enrollment 2426
Recruitment Details The first subject was randomized 22 February 2007 and last subject completed 28 August 2008. Cardiologists, primary care physicians and gastroenterologists were the primary target investigators.
Pre-assignment Details  
Arm/Group Title Esomeprazole 40 Esomeproazole 20 Placebo
Hide Arm/Group Description Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg) Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg) Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
Period Title: Overall Study
Started 817 [1] 804 [1] 805 [1]
Completed 711 [1] 686 [1] 637 [1]
Not Completed 106 118 168
Reason Not Completed
Protocol Violation             19             28             32
Adverse Event             26             33             28
Lack of Efficacy             7             8             48
Withdrawal by Subject             40             34             47
Lost to Follow-up             5             6             5
Safety Reasons             3             1             3
Various reason specified             6             8             5
[1]
ITT/randomised
Arm/Group Title Esomeprazole 40 Esomeproazole 20 Placebo Total
Hide Arm/Group Description Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg) Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg) Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg) Total of all reporting groups
Overall Number of Baseline Participants 817 804 805 2426
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 817 participants 804 participants 805 participants 2426 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
240
  29.4%
246
  30.6%
260
  32.3%
746
  30.8%
>=65 years
577
  70.6%
558
  69.4%
545
  67.7%
1680
  69.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 817 participants 804 participants 805 participants 2426 participants
Female
380
  46.5%
375
  46.6%
402
  49.9%
1157
  47.7%
Male
437
  53.5%
429
  53.4%
403
  50.1%
1269
  52.3%
1.Primary Outcome
Title Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).
Hide Description The occurrence of ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
Time Frame During 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 Esomeproazole 20 Placebo
Hide Arm/Group Description:
Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
Overall Number of Participants Analyzed 817 804 805
Measure Type: Number
Unit of Measure: percentage of participants
1.35 1 6.58
2.Secondary Outcome
Title Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.
Hide Description The occurrence of gastric ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
Time Frame During 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 Esomeproazole 20 Placebo
Hide Arm/Group Description:
Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
Overall Number of Participants Analyzed 817 804 805
Measure Type: Number
Unit of Measure: percentage of participants
1.1 0.75 4.1
3.Secondary Outcome
Title Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.
Hide Description The occurrence of duodenal ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
Time Frame During 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole 40 Esomeproazole 20 Placebo
Hide Arm/Group Description:
Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
Overall Number of Participants Analyzed 817 804 805
Measure Type: Number
Unit of Measure: percentage of participants
0.24 0.25 2.73
4.Secondary Outcome
Title Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit.
Hide Description RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequence ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). The dyspepsia dimension contains the items 'Burning feeling in the center of the upper stomach' and 'Pain in the center of the upper stomach'. Best score possible 0, worst score possible - daily occurrence.
Time Frame RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.
Arm/Group Title Esomeprazole 40 mg Esomeprazole 20 mg Placbo
Hide Arm/Group Description:
Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
Overall Number of Participants Analyzed 782 758 763
Measure Type: Number
Unit of Measure: participants
591 577 504
5.Secondary Outcome
Title Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit.
Hide Description RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequency ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). Gastroesophageal reflux disease (GERD) items: 'Acid taste in the mouth', 'Unpleasant movement of materials upward from the stomach', 'Burning feeling behind the breastbone' and 'Pain behind the breastbone'. Best score possible 0, worst score possible - daily occurrence.
Time Frame RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients randomized who took at least one dose of study drug and completed RDQ questionnaire at baseline and at week 26 or the week prior to last visit were analyzed.
Arm/Group Title Esomeprazole 40 mg Esomeproazole 20 mg Placebo
Hide Arm/Group Description:
Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (acetylsalicyclic acid) (75-325 mg)
Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
Overall Number of Participants Analyzed 782 758 763
Measure Type: Number
Unit of Measure: participants
554 537 451
6.Secondary Outcome
Title Number of Participants With Gastric and/or Duodenal Erosions.
Hide Description [Not Specified]
Time Frame The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
Hide Outcome Measure Data
Hide Analysis Population Description
Patients randomized who had endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
Arm/Group Title Esomeprazole 40 Esomeproazole 20 Placebo
Hide Arm/Group Description:
Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
Overall Number of Participants Analyzed 772 753 748
Measure Type: Number
Unit of Measure: participants
214 213 380
Time Frame [Not Specified]
Adverse Event Reporting Description Nine (9) randomized subjects were not evaluable for safety analysis because they were never exposed to investigational product. Three (3) additional subjects were excluded from safety. They were exposed to investigational product, but did not have any post-dose data.
 
Arm/Group Title Esomeprazole 40 Esomeproazole 20 Placebo
Hide Arm/Group Description Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg) Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg) Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
All-Cause Mortality
Esomeprazole 40 Esomeproazole 20 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Esomeprazole 40 Esomeproazole 20 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   46   40   35 
Cardiac disorders       
Acute Coronary Syndrome  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Angina Pectoris  1  2/814 (0.25%)  0/799 (0.00%)  1/801 (0.12%) 
Angina Unstable  1  2/814 (0.25%)  0/799 (0.00%)  0/801 (0.00%) 
Atrial Fibrillation  1  0/814 (0.00%)  1/799 (0.13%)  1/801 (0.12%) 
Cardiac Arrest  1  0/814 (0.00%)  2/799 (0.25%)  1/801 (0.12%) 
Cardiac Failure  1  0/814 (0.00%)  1/799 (0.13%)  1/801 (0.12%) 
Cardiac Failure Congestive  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Coronary Artery Disease  1  2/814 (0.25%)  1/799 (0.13%)  1/801 (0.12%) 
Coronary Artery Stenosis  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Myocardial Infarction  1  1/814 (0.12%)  1/799 (0.13%)  0/801 (0.00%) 
Myocardial Ischaemia  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Endocrine disorders       
Acromegaly  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Gastrointestinal disorders       
Abdominal Pain  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Abdominal Pain Upper  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Colitis  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Diarrhoea  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Diverticulum  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Duodenal Perforation  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Dyspepsia  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Gastric Ulcer  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Gastritis  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Inguinal Hernia  1  2/814 (0.25%)  0/799 (0.00%)  1/801 (0.12%) 
Intestinal Ischaemia  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Intestinal Obstruction  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Irritable Bowel Syndrome  1  1/814 (0.12%)  1/799 (0.13%)  0/801 (0.00%) 
Pancreatitis  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Pancreatitis Acute  1  2/814 (0.25%)  1/799 (0.13%)  0/801 (0.00%) 
Subileus  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Vomiting  1  1/814 (0.12%)  1/799 (0.13%)  0/801 (0.00%) 
General disorders       
Chest Pain  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Death  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Non-Cardiac Chest Pain  1  1/814 (0.12%)  0/799 (0.00%)  1/801 (0.12%) 
Sudden Death  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Cholecystitis Acute  1  1/814 (0.12%)  1/799 (0.13%)  0/801 (0.00%) 
Cholelithiasis  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Hepatitis Toxic  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Infections and infestations       
Bronchitis  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Diverticulitis  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Erysipelas  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Lobar Pneumonia  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Meningitis  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Pyelonephritis  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Pyelonephritis Acute  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Sepsis  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Urinary Tract Infection  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Injury, poisoning and procedural complications       
Arthropod Bite  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Dislocation Of Joint Prosthesis  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Femur Fracture  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Hand Fracture  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Humerus Fracture  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Joint Dislocation  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Upper Limb Fracture  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Vascular Graft Occlusion  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Wrist Fracture  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Metabolism and nutrition disorders       
Diabetes Mellitus  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Gout  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Hypokalaemia  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Hyponatraemia  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/814 (0.00%)  1/799 (0.13%)  1/801 (0.12%) 
Back Pain  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Flank Pain  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Osteoarthritis  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Pain In Extremity  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma  1  1/814 (0.12%)  0/799 (0.00%)  1/801 (0.12%) 
Adenocarcinoma Pancreas  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Bile Duct Cancer  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Gastric Cancer  1  1/814 (0.12%)  0/799 (0.00%)  1/801 (0.12%) 
Gastrointestinal Tract Adenoma  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Lentigo Maligna Stage Unspecified  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Lung Neoplasm Malignant  1  1/814 (0.12%)  1/799 (0.13%)  0/801 (0.00%) 
Oesophageal Adenocarcinoma  1  0/814 (0.00%)  1/799 (0.13%)  1/801 (0.12%) 
Oesophageal Carcinoma  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Prostate Cancer  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Rectal Cancer  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Renal Cell Carcinoma  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Signet-Ring Cell Carcinoma  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Thyroid Cancer  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Transitional Cell Carcinoma  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Nervous system disorders       
Carotid Arteriosclerosis  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Cerebral Circulatory Failure  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Cerebral Infarction  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Cerebrovascular Accident  1  1/814 (0.12%)  2/799 (0.25%)  0/801 (0.00%) 
Dizziness  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Syncope  1  1/814 (0.12%)  1/799 (0.13%)  0/801 (0.00%) 
Transient Ischaemic Attack  1  0/814 (0.00%)  2/799 (0.25%)  0/801 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Renal Failure Acute  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Benign Prostatic Hyperplasia  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Epistaxis  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Pneumothorax  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Pulmonary Sarcoidosis  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Skin and subcutaneous tissue disorders       
Skin Ulcer  1  0/814 (0.00%)  1/799 (0.13%)  0/801 (0.00%) 
Vascular disorders       
Deep Vein Thrombosis  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Hypertensive Crisis  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Thromboangiitis Obliterans  1  0/814 (0.00%)  0/799 (0.00%)  1/801 (0.12%) 
Varicose Vein  1  1/814 (0.12%)  0/799 (0.00%)  0/801 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Esomeprazole 40 Esomeproazole 20 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32   42   31 
Gastrointestinal disorders       
Diarrhoea  1  21/814 (2.58%)  26/799 (3.25%)  18/801 (2.25%) 
Respiratory, thoracic and mediastinal disorders       
Bronchitis  1  11/814 (1.35%)  16/799 (2.00%)  13/801 (1.62%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Not enough patients had peptic ulcer, gastric ulcer, or duodenal ulcer to report the intended primary endpoint of time to peptic ulcer and two secondary endpoints, time to gastric ulcer and time to duodenal ulcer. Percentage used instead.
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: NCT00441727    
Other Study ID Numbers: D961FC00003
EudraCT No. 2006-005073-22
First Submitted: February 27, 2007
First Posted: March 1, 2007
Results First Submitted: August 28, 2009
Results First Posted: February 13, 2012
Last Update Posted: July 16, 2012