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Trial record 49 of 156 for:    warfarin AND Vitamin K

Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation

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: NCT00684307
Recruitment Status : Completed
First Posted : May 26, 2008
Results First Posted : September 22, 2011
Last Update Posted : March 23, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Nonvalvular Atrial Fibrillation
Interventions Drug: AZD0837
Drug: Vitamin-K antagonist at INR 2-3
Enrollment 1084
Recruitment Details The study population included male and female participants >18 years of age with chronic non-valvular Atrial Fibrillation. The participants were recruited during the time period from 20 February 2007 to 5 June 2008 at medical clinics in Europe.
Pre-assignment Details Participants were enrolled in the study up to two weeks before randomisation and treatment assignment. Participants that were already treated with Vitamin K Antagonists (VKA) at the time of enrollment had their dose adjusted to achive INR <2.0 at the time of randomisation. If this was not achieved the participant was discontinued from the study.
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description AZD0837 150 mg od AZD0837 300 mg od AZD0837 450 mg od AZD0837 200 mg bd [Not Specified]
Period Title: Overall Study
Started 164 [1] 151 156 160 318
On Treatment Period Started 164 151 156 160 318
On Treatment Period Completed 140 [2] 129 128 128 293
Completed 140 129 128 128 293
Not Completed 24 22 28 32 25
Reason Not Completed
Adverse Event             11             6             15             16             8
Development of increasing Liver Function             0             2             0             1             0
Fullfillment of exclusion criteria             1             0             0             3             1
Incorrect enrolment or randomization             4             0             0             0             0
Interupted IP for more than 7 days             0             4             1             3             3
Severe non compliance to protocol             1             0             0             1             2
Participant not willing to continue             7             10             11             5             8
Criteria from the CSR             0             0             1             3             3
[1]
Patients who received treatment
[2]
Patients who completed treatment
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3 Total
Hide Arm/Group Description AZD0837 150 mg od AZD0837 300 mg od AZD0837 450 mg od AZD0837 200 mg bd [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 164 151 156 160 318 949
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 151 participants 156 participants 160 participants 318 participants 949 participants
9.0  (69.9) 9.0  (69.8) 9.4  (69.3) 9.4  (67.8) 9.1  (68.3) 9.18  (69.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 151 participants 156 participants 160 participants 318 participants 949 participants
Female
47
  28.7%
47
  31.1%
49
  31.4%
53
  33.1%
103
  32.4%
299
  31.5%
Male
117
  71.3%
104
  68.9%
107
  68.6%
107
  66.9%
215
  67.6%
650
  68.5%
1.Primary Outcome
Title Bleeding Events
Hide Description Number of patients with a bleeding event while on study drug. Patients with multiple events are counted once
Time Frame 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description:
AZD0837 150 mg od
AZD0837 300 mg od
AZD0837 450 mg od
AZD0837 200 mg bd
[Not Specified]
Overall Number of Participants Analyzed 164 151 156 160 318
Measure Type: Number
Unit of Measure: Participants
18 8 22 17 46
2.Primary Outcome
Title Creatinine
Hide Description Change in Creatinine values from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)
Time Frame 12 weeks according to protocol.(baseline to week 12 visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description:
AZD0837 150 mg od
AZD0837 300 mg od
AZD0837 450 mg od
AZD0837 200 mg bd
[Not Specified]
Overall Number of Participants Analyzed 141 132 133 134 298
Mean (Standard Deviation)
Unit of Measure: umol/L
5.95  (11.18) 4.81  (12.74) 7.56  (14.95) 9.22  (11.24) 0.43  (11.79)
3.Primary Outcome
Title Alanine Aminotransferase (ALAT)
Hide Description Number of patients while on study drug with ALAT>=3 times upper limit of normal.l
Time Frame 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description:
AZD0837 150 mg od
AZD0837 300 mg od
AZD0837 450 mg od
AZD0837 200 mg bd
[Not Specified]
Overall Number of Participants Analyzed 156 147 150 152 315
Measure Type: Number
Unit of Measure: Participants
6 1 5 2 5
4.Primary Outcome
Title Bilirubin
Hide Description Number of patients while on study drug with Bilirubin>=2 times upper limit of normal
Time Frame 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description:
AZD0837 150 mg od
AZD0837 300 mg od
AZD0837 450 mg od
AZD0837 200 mg bd
[Not Specified]
Overall Number of Participants Analyzed 156 147 150 152 315
Measure Type: Number
Unit of Measure: Participants
1 0 0 3 2
5.Secondary Outcome
Title D-Dimer
Hide Description Change in D-Dimer values from enrolment to week 12 visit for VKA naïve patients while on study drug (week 12 visit-enrolment)
Time Frame 14 weeks according to protocol.(enrolment to week 12 visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description:
AZD0837 150 mg od
AZD0837 300 mg od
AZD0837 450 mg od
AZD0837 200 mg bd
[Not Specified]
Overall Number of Participants Analyzed 37 32 35 43 87
Median (Full Range)
Unit of Measure: ng/mL
-46.4
(-382 to 170)
-76.9
(-613 to 29)
-45.2
(-1817 to 230)
-68.0
(-1313 to 69)
-50.3
(-3955 to 516)
6.Secondary Outcome
Title Activated Partial Thromboplastin Time (APTT)
Hide Description Change in Activated partial thromboplastin time (APTT) from baseline to week 12 visit for VKA naïve patients while on study drug (week 12 visit-baseline)
Time Frame 12 weeks according to protocol.(baseline to week 12 visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description:
AZD0837 150 mg od
AZD0837 300 mg od
AZD0837 450 mg od
AZD0837 200 mg bd
[Not Specified]
Overall Number of Participants Analyzed 35 30 34 41 0
Median (Full Range)
Unit of Measure: sec
8.2
(-1 to 24)
12.3
(2 to 110)
17.4
(-79 to 52)
16.4
(2 to 60)
7.Secondary Outcome
Title Ecarin Clotting Time (ECT)
Hide Description Change in Ecarin clotting time (ECT) from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)
Time Frame 12 weeks according to protocol.(baseline to week 12 visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description:
AZD0837 150 mg od
AZD0837 300 mg od
AZD0837 450 mg od
AZD0837 200 mg bd
[Not Specified]
Overall Number of Participants Analyzed 94 85 85 98 0
Median (Full Range)
Unit of Measure: sec
33.5
(-1 to 86)
53.0
(15 to 93)
64.0
(2 to 134)
73.5
(-1 to 166)
8.Secondary Outcome
Title Plasma Concentration of AZD0837 (Prodrug)
Hide Description Assessment made on the week 12 visit
Time Frame 12 weeks after baseline according to protocol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description:
AZD0837 150 mg od
AZD0837 300 mg od
AZD0837 450 mg od
AZD0837 200 mg bd
[Not Specified]
Overall Number of Participants Analyzed 101 104 107 112 0
Median (Full Range)
Unit of Measure: nmol/L
199.8
(10.0 to 2334.0)
617.5
(10.0 to 5355.0)
564.5
(10.0 to 14720.0)
1143.5
(10.0 to 9644.0)
9.Secondary Outcome
Title Plasma Concentration of AR-H067637XX (Active Metabolite)
Hide Description Assessment made on the week 12 visit
Time Frame 12 weeks after baseline according to protocol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description:
AZD0837 150 mg od
AZD0837 300 mg od
AZD0837 450 mg od
AZD0837 200 mg bd
[Not Specified]
Overall Number of Participants Analyzed 101 104 107 112 0
Median (Full Range)
Unit of Measure: nmol/L
223.8
(10.0 to 503.9)
373.6
(10.0 to 1074.0)
454.8
(10.0 to 1490.0)
600.8
(10.0 to 1523.0)
10.Secondary Outcome
Title Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT
Hide Description Oral clearance of AR-H067637XX in subgroup of patients with genotype TT for gene polymorphism ABCB1 C3435T
Time Frame 36 weeks according to protocol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description:
AZD0837 150 mg od
AZD0837 300 mg od
AZD0837 450 mg od
AZD0837 200 mg bd
[Not Specified]
Overall Number of Participants Analyzed 34 41 27 35 0
Median (Full Range)
Unit of Measure: L/h
39.7
(22.9 to 79.7)
42.4
(13.7 to 699)
36.3
(21.4 to 62.9)
35.6
(19.7 to 67.3)
11.Secondary Outcome
Title Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC
Hide Description Oral clearance of AR-H067637XX in subgroup of patients with genotype TC for gene polymorphism ABCB1 C3435T
Time Frame 36 weeks according to protocol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description:
AZD0837 150 mg od
AZD0837 300 mg od
AZD0837 450 mg od
AZD0837 200 mg bd
[Not Specified]
Overall Number of Participants Analyzed 73 64 64 66 0
Median (Full Range)
Unit of Measure: L/h
39.2
(19.6 to 130.5)
39.3
(17.2 to 138.6)
37.7
(18 to 79.4)
40
(17.4 to 96.7)
12.Secondary Outcome
Title Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC
Hide Description Oral clearance of AR-H067637XX in subgroup of patients with genotype CC for gene polymorphism ABCB1 C3435T
Time Frame 36 weeks according to protocol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 150 mg od 300 mg od 450 mg od 200 mg bd VKA INR 2-3
Hide Arm/Group Description:
AZD0837 150 mg od
AZD0837 300 mg od
AZD0837 450 mg od
AZD0837 200 mg bd
[Not Specified]
Overall Number of Participants Analyzed 28 21 31 30 0
Median (Full Range)
Unit of Measure: L/h
40.9
(23.7 to 66)
41.1
(21.8 to 62.1)
43.4
(22.8 to 78)
39.6
(26.5 to 107.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD0837 150 mg od AZD0837 300 mg od AZD0837 450 mg od AZD0837 200 mg bd VKA INR 2-3
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
AZD0837 150 mg od AZD0837 300 mg od AZD0837 450 mg od AZD0837 200 mg bd VKA INR 2-3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZD0837 150 mg od AZD0837 300 mg od AZD0837 450 mg od AZD0837 200 mg bd VKA INR 2-3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/166 (7.23%)   20/152 (13.16%)   31/157 (19.75%)   27/161 (16.77%)   50/319 (15.67%) 
Blood and lymphatic system disorders           
Haemorrhagic Anaemia  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Cardiac disorders           
Cardiac Failure  1  1/166 (0.60%)  3/152 (1.97%)  1/157 (0.64%)  1/161 (0.62%)  6/319 (1.88%) 
Atrial Fibrillation  1  0/166 (0.00%)  2/152 (1.32%)  4/157 (2.55%)  0/161 (0.00%)  4/319 (1.25%) 
Acute Myocardial Infarction  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Angina Pectoris  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  1/161 (0.62%)  1/319 (0.31%) 
Angina Unstable  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  1/319 (0.31%) 
Atrial Flutter  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  1/161 (0.62%)  1/319 (0.31%) 
Atrioventricular Block Complete  1  1/166 (0.60%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Bradycardia  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  1/161 (0.62%)  1/319 (0.31%) 
Cardiac Failure Acute  1  1/166 (0.60%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Cardiac Failure Congestive  1  1/166 (0.60%)  1/152 (0.66%)  1/157 (0.64%)  0/161 (0.00%)  1/319 (0.31%) 
Coronary Artery Occlusion  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Myocardial Infarction  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Myocardial Ischaemia  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  1/319 (0.31%) 
Sick Sinus Syndrome  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Ventricular Tachycardia  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Ear and labyrinth disorders           
Vertigo  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Eye disorders           
Cataract  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  2/319 (0.63%) 
Glaucoma  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Vitreous Haemorrhage  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Gastrointestinal disorders           
Abdominal Hernia  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Abdominal Pain  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Anal Ulcer  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Diarrhoea  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Gastric Ulcer  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Haematemesis  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Haematochezia  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Inguinal Hernia  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Periodontal Disease  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Rectal Haemorrhage  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Asthenia  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Chest Pain  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Non-Cardiac Chest Pain  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Sudden Death  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Hepatobiliary disorders           
Cholelithiasis  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Chronic Hepatitis  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Immune system disorders           
Corneal Graft Rejection  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Hypersensitivity  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Infections and infestations           
Appendicitis  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  2/161 (1.24%)  0/319 (0.00%) 
Abscess Limb  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Arthritis Bacterial  1  1/166 (0.60%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Erysipelas  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Gastroenteritis  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Infective Spondylitis  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Lower Respiratory Tract Infection  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Postoperative Wound Infection  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Pyelonephritis Acute  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Urinary Tract Infection  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Injury, poisoning and procedural complications           
Contusion  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Femoral Neck Fracture  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Limb Injury  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Road Traffic Accident  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Tibia Fracture  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Haemoglobin Decreased  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  2/161 (1.24%)  0/319 (0.00%) 
Alanine Aminotransferase Increased  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Blood Glucose Increased  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Metabolism and nutrition disorders           
Diabetes Mellitus  1  1/166 (0.60%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Gout  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Musculoskeletal and connective tissue disorders           
Arthritis  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Back Pain  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Muscular Weakness  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Myalgia  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Myositis  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Osteoarthritis  1  1/166 (0.60%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Basal Cell Carcinoma  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Bladder Cancer  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Brain Neoplasm  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Breast Cancer  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Colon Neoplasm  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Prostatic Adenoma  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Nervous system disorders           
Ischaemic Stroke  1  2/166 (1.20%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Syncope  1  0/166 (0.00%)  1/152 (0.66%)  2/157 (1.27%)  2/161 (1.24%)  2/319 (0.63%) 
Dizziness  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Headache  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Syncope Vasovagal  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Transient Ischaemic Attack  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  1/319 (0.31%) 
Vascular Encephalopathy  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Vertebrobasilar Insufficiency  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Psychiatric disorders           
Depression  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Renal and urinary disorders           
Haematuria  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Asthma  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Epistaxis  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Pleural Effusion  1  0/166 (0.00%)  1/152 (0.66%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Pulmonary Embolism  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  1/319 (0.31%) 
Vascular disorders           
Arterial Stenosis Limb  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Axillary Vein Thrombosis  1  1/166 (0.60%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Deep Vein Thrombosis  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Hypertension  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  1/161 (0.62%)  0/319 (0.00%) 
Hypotension  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Orthostatic Hypotension  1  0/166 (0.00%)  0/152 (0.00%)  1/157 (0.64%)  0/161 (0.00%)  0/319 (0.00%) 
Peripheral Artery Aneurysm  1  0/166 (0.00%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  1/319 (0.31%) 
Peripheral Embolism  1  1/166 (0.60%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Subclavian Vein Thrombosis  1  1/166 (0.60%)  0/152 (0.00%)  0/157 (0.00%)  0/161 (0.00%)  0/319 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD0837 150 mg od AZD0837 300 mg od AZD0837 450 mg od AZD0837 200 mg bd VKA INR 2-3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   46/166 (27.71%)   62/152 (40.79%)   46/157 (29.30%)   59/161 (36.65%)   67/319 (21.00%) 
Gastrointestinal disorders           
DIARRHOEA  1  14/166 (8.43%)  23/152 (15.13%)  12/157 (7.64%)  17/161 (10.56%)  15/319 (4.70%) 
NAUSEA  1  6/166 (3.61%)  8/152 (5.26%)  8/157 (5.10%)  9/161 (5.59%)  15/319 (4.70%) 
FLATULENCE  1  10/166 (6.02%)  11/152 (7.24%)  6/157 (3.82%)  10/161 (6.21%)  1/319 (0.31%) 
ABDOMINAL PAIN UPPER  1  2/166 (1.20%)  1/152 (0.66%)  8/157 (5.10%)  2/161 (1.24%)  3/319 (0.94%) 
Infections and infestations           
NASOPHARYNGITIS  1  10/166 (6.02%)  10/152 (6.58%)  5/157 (3.18%)  10/161 (6.21%)  20/319 (6.27%) 
Nervous system disorders           
DIZZINESS  1  4/166 (2.41%)  9/152 (5.92%)  7/157 (4.46%)  11/161 (6.83%)  13/319 (4.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00684307     History of Changes
Other Study ID Numbers: D1250C00008
First Submitted: May 22, 2008
First Posted: May 26, 2008
Results First Submitted: August 17, 2011
Results First Posted: September 22, 2011
Last Update Posted: March 23, 2012