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Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

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: NCT00316082
Recruitment Status : Completed
First Posted : April 20, 2006
Results First Posted : September 25, 2009
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetes
Interventions Drug: Saxagliptin
Drug: Placebo
Drug: metformin
Enrollment 365
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Saxagliptin 2.5 mg Once in the Morning (QAM) Saxagliptin 5 mg QAM Saxagliptin 2.5/5 mg QAM Saxagliptin 5 mg Once in the Evening (QPM) Placebo
Hide Arm/Group Description The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily. The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily. The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM. The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily. The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
Period Title: Overall Study
Started 74 74 71 72 74
Completed Study Without Being Rescued 25 35 29 27 31
Completed 41 52 44 46 48
Not Completed 33 22 27 26 26
Reason Not Completed
Lack of Efficacy             2             3             3             4             6
Withdrawal of Consent by Subject             10             8             2             9             5
Lost to Follow-up             7             6             7             8             6
Poor/noncompliance             6             1             4             1             4
Adverse Event             4             2             5             1             3
Subject no longer meets study criteria             3             1             2             2             1
Physician Decision             1             1             2             1             1
Death             0             0             1             0             0
Administrative reason by sponsor             0             0             1             0             0
Arm/Group Title Saxagliptin 2.5 mg Once in the Morning (QAM) Saxagliptin 5 mg QAM Saxagliptin 2.5/5 mg QAM Saxagliptin 5 mg Once in the Evening (QPM) Placebo Total
Hide Arm/Group Description The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily. The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily. The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM. The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily. The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily. Total of all reporting groups
Overall Number of Baseline Participants 74 74 71 72 74 365
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 74 participants 71 participants 72 participants 74 participants 365 participants
55.24  (10.44) 54.66  (9.71) 54.28  (10.93) 55.11  (10.35) 55.57  (10.32) 54.98  (10.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 71 participants 72 participants 74 participants 365 participants
Female
49
  66.2%
36
  48.6%
34
  47.9%
39
  54.2%
39
  52.7%
197
  54.0%
Male
25
  33.8%
38
  51.4%
37
  52.1%
33
  45.8%
35
  47.3%
168
  46.0%
1.Primary Outcome
Title Change From Baseline in Hemoglobin A1 (A1C) at Week 24
Hide Description Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement. If participant received rescue medication, measurement must have been taken before rescue.
Arm/Group Title Saxagliptin 2.5 mg QAM Saxagliptin 5 mg QAM Saxagliptin 2.5/5 mg QAM Placebo
Hide Arm/Group Description:
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
Overall Number of Participants Analyzed 67 69 69 68
Mean (Standard Error)
Unit of Measure: percent
Baseline Mean 8.04  (0.105) 7.93  (0.106) 8.02  (0.131) 7.79  (0.112)
Week 24 Mean 7.30  (0.106) 7.27  (0.129) 7.37  (0.137) 7.57  (0.141)
Adjusted Mean Change from Baseline -0.71  (0.103) -0.66  (0.102) -0.63  (0.102) -0.26  (0.103)
2.Secondary Outcome
Title Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM
Hide Description Mean change from baseline in A1C at Week 24, adjusted for baseline value.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
Arm/Group Title Saxagliptin 5 mg QPM Placebo
Hide Arm/Group Description:
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
Overall Number of Participants Analyzed 70 68
Mean (Standard Error)
Unit of Measure: percent
Baseline Mean 7.88  (0.111) 7.79  (0.112)
Week 24 Mean 7.29  (0.124) 7.57  (0.141)
Adjusted Mean Change from Baseline -0.61  (0.101) -0.26  (0.103)
3.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Hide Description Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
Arm/Group Title Saxagliptin 2.5 mg Once in the Morning (QAM) Saxagliptin 5 mg QAM Saxagliptin 2.5/5 mg QAM Saxagliptin 5 mg Once in the Evening (QPM) Placebo
Hide Arm/Group Description:
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
Overall Number of Participants Analyzed 70 71 71 71 71
Mean (Standard Error)
Unit of Measure: mg/dL
Baseline Mean 156.6  (3.96) 162.2  (4.24) 170.6  (6.15) 159.6  (5.32) 158.6  (5.44)
Week 24 Mean 146.8  (3.79) 151.3  (5.88) 155.2  (5.88) 152.4  (5.88) 162.9  (6.28)
Adjusted Mean Change from Baseline -11.4  (4.50) -10.7  (4.46) -12.5  (4.48) -7.9  (4.46) 3.3  (4.46)
4.Secondary Outcome
Title Percentage of Participants Achieving A1C < 7% at Week 24
Hide Description Percentage of participants achieving A1C < 7%, the American Diabetes Association’s defined goal for glycemia, at each dose of saxagliptin versus placebo at Week 24.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 24 LOCF analysis, participants must have had at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
Arm/Group Title Saxagliptin 2.5 mg Once in the Morning (QAM) Saxagliptin 5 mg QAM Saxagliptin 2.5/5 mg QAM Saxagliptin 5 mg Once in the Evening (QPM) Placebo
Hide Arm/Group Description:
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
Overall Number of Participants Analyzed 67 69 69 70 68
Measure Type: Number
Unit of Measure: Percentage of participants
35.8 44.9 43.5 38.6 35.3
5.Secondary Outcome
Title Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24
Hide Description Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline value.
Time Frame Baseline, Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 24 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. If a participant received rescue medication, then that measurement must have been taken before rescue.
Arm/Group Title Saxagliptin 2.5 mg Once in the Morning (QAM) Saxagliptin 5 mg QAM Saxagliptin 2.5/5 mg QAM Saxagliptin 5 mg Once in the Evening (QPM) Placebo
Hide Arm/Group Description:
The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
Overall Number of Participants Analyzed 48 48 47 43 47
Mean (Standard Error)
Unit of Measure: mg*min/dL
Baseline Mean 47432  (1496.6) 50417  (1561.5) 50032  (1684.7) 47078  (1941.9) 47640  (1759.7)
Week 24 Mean 39798  (1347.0) 41562  (1489.3) 41745  (1739.2) 41530  (1962.7) 44861  (1854.7)
Adjusted Mean Change from Baseline -8014  (1246.9) -8218  (1249.1) -7781  (1261.0) -6048  (1318.2) -3088  (1259.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Saxagliptin 2.5/5 mg QAM Saxagliptin 2.5 mg QAM Saxagliptin 5 mg QAM Saxagliptin 5 mg QPM
Hide Arm/Group Description The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily. The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM. The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily. The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily. The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
All-Cause Mortality
Placebo Saxagliptin 2.5/5 mg QAM Saxagliptin 2.5 mg QAM Saxagliptin 5 mg QAM Saxagliptin 5 mg QPM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Saxagliptin 2.5/5 mg QAM Saxagliptin 2.5 mg QAM Saxagliptin 5 mg QAM Saxagliptin 5 mg QPM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/74 (6.76%)   7/71 (9.86%)   7/74 (9.46%)   8/74 (10.81%)   4/72 (5.56%) 
Cardiac disorders           
ANGINA PECTORIS  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  1/74 (1.35%)  0/72 (0.00%) 
ANGINA UNSTABLE  1  0/74 (0.00%)  0/71 (0.00%)  1/74 (1.35%)  0/74 (0.00%)  0/72 (0.00%) 
ATRIAL FIBRILLATION  1  0/74 (0.00%)  1/71 (1.41%)  0/74 (0.00%)  0/74 (0.00%)  0/72 (0.00%) 
COR PULMONALE ACUTE  1  0/74 (0.00%)  0/71 (0.00%)  1/74 (1.35%)  0/74 (0.00%)  0/72 (0.00%) 
CORONARY ARTERY DISEASE  1  0/74 (0.00%)  0/71 (0.00%)  1/74 (1.35%)  0/74 (0.00%)  0/72 (0.00%) 
ACUTE MYOCARDIAL INFARCTION  1  2/74 (2.70%)  0/71 (0.00%)  0/74 (0.00%)  0/74 (0.00%)  0/72 (0.00%) 
Ear and labyrinth disorders           
VERTIGO  1  0/74 (0.00%)  0/71 (0.00%)  1/74 (1.35%)  0/74 (0.00%)  0/72 (0.00%) 
Eye disorders           
RETINAL DETACHMENT  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  1/74 (1.35%)  0/72 (0.00%) 
Gastrointestinal disorders           
RECTAL POLYP  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  0/74 (0.00%)  1/72 (1.39%) 
ABDOMINAL PAIN  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  1/74 (1.35%)  0/72 (0.00%) 
FOOD POISONING  1  0/74 (0.00%)  1/71 (1.41%)  0/74 (0.00%)  0/74 (0.00%)  0/72 (0.00%) 
GASTRITIS EROSIVE  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  0/74 (0.00%)  1/72 (1.39%) 
General disorders           
CHEST PAIN  1  0/74 (0.00%)  1/71 (1.41%)  1/74 (1.35%)  0/74 (0.00%)  0/72 (0.00%) 
Hepatobiliary disorders           
CHOLECYSTITIS  1  0/74 (0.00%)  1/71 (1.41%)  0/74 (0.00%)  0/74 (0.00%)  0/72 (0.00%) 
CHOLECYSTITIS ACUTE  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  0/74 (0.00%)  2/72 (2.78%) 
Infections and infestations           
PNEUMONIA  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  1/74 (1.35%)  0/72 (0.00%) 
CELLULITIS  1  0/74 (0.00%)  0/71 (0.00%)  1/74 (1.35%)  0/74 (0.00%)  0/72 (0.00%) 
INFECTED BITES  1  0/74 (0.00%)  1/71 (1.41%)  0/74 (0.00%)  0/74 (0.00%)  0/72 (0.00%) 
PNEUMOCOCCAL SEPSIS  1  0/74 (0.00%)  1/71 (1.41%)  0/74 (0.00%)  0/74 (0.00%)  0/72 (0.00%) 
Injury, poisoning and procedural complications           
OVERDOSE  1  0/74 (0.00%)  0/71 (0.00%)  2/74 (2.70%)  0/74 (0.00%)  1/72 (1.39%) 
LIGAMENT RUPTURE  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  1/74 (1.35%)  0/72 (0.00%) 
FEMORAL NECK FRACTURE  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  1/74 (1.35%)  0/72 (0.00%) 
SPINAL COMPRESSION FRACTURE  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  1/74 (1.35%)  0/72 (0.00%) 
Metabolism and nutrition disorders           
HYPOGLYCAEMIA  1  1/74 (1.35%)  0/71 (0.00%)  0/74 (0.00%)  0/74 (0.00%)  0/72 (0.00%) 
Musculoskeletal and connective tissue disorders           
OSTEOARTHRITIS  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  1/74 (1.35%)  0/72 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
UTERINE CANCER  1  0/74 (0.00%)  1/71 (1.41%)  0/74 (0.00%)  0/74 (0.00%)  0/72 (0.00%) 
PANCREATIC CARCINOMA  1  0/74 (0.00%)  1/71 (1.41%)  0/74 (0.00%)  0/74 (0.00%)  0/72 (0.00%) 
HEPATIC CANCER METASTATIC  1  0/74 (0.00%)  1/71 (1.41%)  0/74 (0.00%)  0/74 (0.00%)  0/72 (0.00%) 
Nervous system disorders           
TRANSIENT ISCHAEMIC ATTACK  1  1/74 (1.35%)  0/71 (0.00%)  0/74 (0.00%)  0/74 (0.00%)  0/72 (0.00%) 
Renal and urinary disorders           
NEPHROLITHIASIS  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  1/74 (1.35%)  0/72 (0.00%) 
CALCULUS URETERIC  1  1/74 (1.35%)  0/71 (0.00%)  0/74 (0.00%)  0/74 (0.00%)  0/72 (0.00%) 
Skin and subcutaneous tissue disorders           
INTERTRIGO  1  0/74 (0.00%)  0/71 (0.00%)  1/74 (1.35%)  0/74 (0.00%)  0/72 (0.00%) 
Vascular disorders           
ARTERIAL DISORDER  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  1/74 (1.35%)  0/72 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Saxagliptin 2.5/5 mg QAM Saxagliptin 2.5 mg QAM Saxagliptin 5 mg QAM Saxagliptin 5 mg QPM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/74 (29.73%)   30/71 (42.25%)   32/74 (43.24%)   33/74 (44.59%)   29/72 (40.28%) 
Gastrointestinal disorders           
NAUSEA  1  1/74 (1.35%)  4/71 (5.63%)  4/74 (5.41%)  2/74 (2.70%)  3/72 (4.17%) 
DIARRHOEA  1  1/74 (1.35%)  1/71 (1.41%)  7/74 (9.46%)  4/74 (5.41%)  4/72 (5.56%) 
DYSPEPSIA  1  0/74 (0.00%)  4/71 (5.63%)  3/74 (4.05%)  2/74 (2.70%)  0/72 (0.00%) 
General disorders           
ASTHENIA  1  3/74 (4.05%)  4/71 (5.63%)  0/74 (0.00%)  1/74 (1.35%)  2/72 (2.78%) 
OEDEMA PERIPHERAL  1  3/74 (4.05%)  2/71 (2.82%)  5/74 (6.76%)  2/74 (2.70%)  1/72 (1.39%) 
Infections and infestations           
RHINITIS  1  1/74 (1.35%)  4/71 (5.63%)  0/74 (0.00%)  1/74 (1.35%)  0/72 (0.00%) 
SINUSITIS  1  3/74 (4.05%)  5/71 (7.04%)  5/74 (6.76%)  3/74 (4.05%)  0/72 (0.00%) 
GASTROENTERITIS  1  0/74 (0.00%)  3/71 (4.23%)  1/74 (1.35%)  5/74 (6.76%)  1/72 (1.39%) 
NASOPHARYNGITIS  1  3/74 (4.05%)  3/71 (4.23%)  3/74 (4.05%)  4/74 (5.41%)  5/72 (6.94%) 
URINARY TRACT INFECTION  1  2/74 (2.70%)  3/71 (4.23%)  4/74 (5.41%)  3/74 (4.05%)  4/72 (5.56%) 
UPPER RESPIRATORY TRACT INFECTION  1  7/74 (9.46%)  11/71 (15.49%)  11/74 (14.86%)  10/74 (13.51%)  11/72 (15.28%) 
Injury, poisoning and procedural complications           
JOINT INJURY  1  0/74 (0.00%)  0/71 (0.00%)  0/74 (0.00%)  4/74 (5.41%)  1/72 (1.39%) 
Musculoskeletal and connective tissue disorders           
BACK PAIN  1  3/74 (4.05%)  4/71 (5.63%)  3/74 (4.05%)  5/74 (6.76%)  2/72 (2.78%) 
ARTHRALGIA  1  3/74 (4.05%)  4/71 (5.63%)  2/74 (2.70%)  1/74 (1.35%)  5/72 (6.94%) 
PAIN IN EXTREMITY  1  1/74 (1.35%)  5/71 (7.04%)  2/74 (2.70%)  3/74 (4.05%)  5/72 (6.94%) 
Nervous system disorders           
HEADACHE  1  3/74 (4.05%)  2/71 (2.82%)  4/74 (5.41%)  5/74 (6.76%)  2/72 (2.78%) 
Respiratory, thoracic and mediastinal disorders           
COUGH  1  2/74 (2.70%)  3/71 (4.23%)  3/74 (4.05%)  4/74 (5.41%)  2/72 (2.78%) 
Vascular disorders           
HYPERTENSION  1  1/74 (1.35%)  4/71 (5.63%)  3/74 (4.05%)  3/74 (4.05%)  0/72 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
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Name/Title: Boaz Hirschberg
Organization: AstraZeneca Pharmaceuticals
EMail: ClinicalTrialTransparency@astrazeneca.com
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00316082     History of Changes
Other Study ID Numbers: CV181-038
First Submitted: April 18, 2006
First Posted: April 20, 2006
Results First Submitted: August 17, 2009
Results First Posted: September 25, 2009
Last Update Posted: April 29, 2015