Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Assessing Saxagliptin Treatment 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: NCT00374907
Recruitment Status : Completed
First Posted : September 12, 2006
Results First Posted : January 21, 2011
Last Update Posted : May 7, 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 Type 2 Diabetes
Interventions Drug: Saxagliptin
Drug: Placebo
Drug: Metformin (blinded)
Drug: Metformin (open-label)
Enrollment 156
Recruitment Details  
Pre-assignment Details 156 participants were enrolled in the study; 110 participants failed screening; 10 subjects entered lead-in and discontinued prior to randomization.
Arm/Group Title Saxagliptin 5 mg Placebo / Metformin
Hide Arm/Group Description Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term). Metformin 500-1500 mg (open-label, as needed for rescue in LT). Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, up to 104 weeks starting at Week 12 (end of ST period). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
Period Title: 12-Week Short-term Period
Started 20 16
Completed 17 15
Not Completed 3 1
Reason Not Completed
Subject Withdrew Consent             3             1
Period Title: 116-Week Short-term + Long-term Period
Started 20 16
Completed 12-week Short Term Period 17 15
Completed 7 2
Not Completed 13 14
Reason Not Completed
Subject Withdrew Consent             8             9
Lack of Efficacy             4             2
Adverse Event             0             2
Lost to Follow-up             1             1
Arm/Group Title Saxagliptin 5 mg Placebo / Metformin Total
Hide Arm/Group Description Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term) Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks Total of all reporting groups
Overall Number of Baseline Participants 20 16 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 16 participants 36 participants
58
(43 to 69)
55
(45 to 69)
55.5
(43 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 16 participants 36 participants
Female
12
  60.0%
10
  62.5%
22
  61.1%
Male
8
  40.0%
6
  37.5%
14
  38.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 16 participants 36 participants
White 16 12 28
Black/African American 3 4 7
Other 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
North America Number Analyzed 20 participants 16 participants 36 participants
20 16 36
Body Mass Index (BMI)  
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 20 participants 16 participants 36 participants
33.36
(24.67 to 39.35)
32.31
(25.56 to 38.55)
33.01
(24.67 to 39.35)
1.Primary Outcome
Title Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12
Hide Description Adjusted percent change in the insulin secretion rate AUC during a hyperglycemic clamp with an enteral glucose load [intravenous-oral hyperglycemic clamp (180-480 minutes)] at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants with both a baseline and post-baseline value (up to Week 12).
Arm/Group Title Short Term Period: Saxagliptin 5 mg Short Term Period: Placebo
Hide Arm/Group Description:
Tablet, Oral, 5 mg, once daily, up to 12 weeks
Tablet, Oral, 0 mg, once daily, up to 12 weeks
Overall Number of Participants Analyzed 16 15
Geometric Mean (95% Confidence Interval)
Unit of Measure: Percent Change (Percentage of Baseline)
15.9
(4.2 to 29.0)
-2.2
(-12.4 to 9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Short Term Period: Saxagliptin 5 mg, Short Term Period: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0350
Comments Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method ANCOVA
Comments Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.
Method of Estimation Estimation Parameter Adjusted Percent Difference
Estimated Value 18.5
Confidence Interval (2-Sided) 95%
1.3 to 38.7
Estimation Comments ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment
2.Secondary Outcome
Title Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12
Hide Description Adjusted percent change in the insulin secretion rate AUC during an intravenous hyperglycemic clamp (120-180 minutes) at Week 12. The method used for calculating the insulin secretion rate was C-peptide deconvolution.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized Participants with both a baseline and post-baseline value (up to Week 12).
Arm/Group Title Short Term Period: Saxagliptin 5 mg Short Term Period: Placebo
Hide Arm/Group Description:
Tablet, Oral, 5 mg, once daily, up to 12 weeks
Tablet, Oral, 0 mg, once daily, up to 12 weeks
Overall Number of Participants Analyzed 18 16
Geometric Mean (95% Confidence Interval)
Unit of Measure: Percent Change (Percentage of Baseline)
22.6
(7.2 to 40.4)
-4.1
(-17.4 to 11.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Short Term Period: Saxagliptin 5 mg, Short Term Period: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0204
Comments Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.
Method ANCOVA
Comments Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.
Method of Estimation Estimation Parameter Adjusted Percent Difference
Estimated Value 27.9
Confidence Interval (2-Sided) 95%
4.2 to 57.1
Estimation Comments ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment
3.Other Pre-specified Outcome
Title Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period
Hide Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related events=relationship of certain, probable, possible, or missing.
Time Frame 116 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Saxagliptin 5 mg Placebo / Metformin
Hide Arm/Group Description:
Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
Overall Number of Participants Analyzed 20 16
Measure Type: Number
Unit of Measure: participants
At Least 1 AE 17 14
At Least 1 Related AE 7 6
Deaths 0 0
At Least 1 SAE 1 2
At Least 1 Related SAE 0 0
Discontinuations Due to SAEs 0 1
Discontinuations Due to AEs 0 2
4.Other Pre-specified Outcome
Title Marked Laboratory Abnormalities - During ST + LT Treatment Period
Hide Description A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. Pre-Rx=pretreatment; ULN=upper limit of normal; ALP=alkaline phosphatase; AST=aspartate aminotransferase; ALT=alanine aminotransferase; BUN=blood urea nitrogen; unspec.=unspecified; sodium serum low: <0.9 x Pre-Rx & <=130mEq/L / high: >1.1 x Pre-Rx & >=150mEq/L; potassium, serum low: <=0.8 x Pre-Rx & >=6.0mEq/L / high: 1.2 x Pre-Rx & >=6.0mEq/L; LLN=lower limit of normal.
Time Frame 116 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Participants Analyzed=Treated participants; n=number of treated subjects with baseline value and at least one value during the ST + LT treatment period.
Arm/Group Title Saxagliptin 5 mg Placebo / Metformin
Hide Arm/Group Description:
Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
Overall Number of Participants Analyzed 20 16
Measure Type: Number
Unit of Measure: participants
Hemoglobin < 8 g/dL (n=0, 0) 0 0
Hematocrit < 0.75 x pre-Rx (n=0, 0) 0 0
Platelets < 50 x 10^9 c/L (n=0, 0) 0 0
Platelets > 1.5 x ULN (n=0, 0) 0 0
Leukocytes < 2 x 1000 c/uL (n=0, 0) 0 0
Neutrophils+Bands <1x1000 c/uL (n=18, 0) 1 0
Eosinophils >0.9x1000 c/uL (n=18, 0) 1 0
Lymphocytes <=0.75x1000 c/uL (n=18, 0) 2 0
ALP >3 x pre-Rx and >ULN (n=0, 0) 0 0
AST >3 x ULN (n=0, 0) 0 0
AST >5 x ULN (n=0, 0) 0 0
ALT >3 x ULN (n=0, 0) 0 0
ALT >5 x ULN (n=0, 0) 0 0
Bilirubin Total >2mg/dL (n=0, 0) 0 0
BUN >2 x pre-Rx and >ULN (n=0, 0) 0 0
Creatinine >2.5 mg/dL (n=0, 0) 0 0
Glucose, Serum Fasting < 50 mg/dL (n=0, 0) 0 0
Glucose, Serum Fasting > 500 mg/dL (n=0, 0) 0 0
Glucose, Serum Unspec. < 50 mg/dL (n=0, 0) 0 0
Glucose, Serum Unspec. > 500 mg/dL (n=0, 0) 0 0
Glucose, Plasma Fasting <50 mg/dL (n=0, 0) 0 0
Glucose,Plasma Fasting >500 mg/dL (n=0, 0) 0 0
Glucose, Plasma Unspec. <50 mg/dL (n=0, 0) 0 0
Glucose, Plasma Unspec. >500 mg/dL (n=18, 16) 8 9
Sodium, Serum Low (see description) (n=0, 0) 0 0
Sodium, Serum High (see description) (n=0, 0) 0 0
Potassium, Serum Low (see description) (n=0, 0) 0 0
Potassium, Serum High (see description) (n=0, 0) 0 0
Chloride < 90 mEq/L (n=0, 0) 0 0
Chloride > 120 mEq/L (n=0, 0) 0 0
Albumin < 0.9 LLN (n=0, 0) 0 0
Creatine Kinase > 5 x ULN (n=18, 16) 1 1
Uric Acid > 1.5 x ULN (n=0, 0) 0 0
Protein Urine, >=2-4 (n=0, 0) 0 0
Blood Urine >=2-4 (n=18, 0) 1 0
Red Blood Cells Urine >=2-4 (n=0, 0) 0 0
White Blood Cells Urine >=2-4 (n=0, 0) 2 1
Time Frame Short term period (up to 12 weeks) + long term period (up to 104 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PLACEBO/METFORMIN SAXAGLIPTIN 5 MG
Hide Arm/Group Description Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks (short term); Metformin Tablet, Oral, 500 mg titrated to 1000 mg, once daily, up to 104 weeks (long term) Tablet, Oral, 5 mg, once daily, up to 12 weeks (short term); Tablet, Oral, 5 mg, once daily, up to 104 weeks (long term)
All-Cause Mortality
PLACEBO/METFORMIN SAXAGLIPTIN 5 MG
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PLACEBO/METFORMIN SAXAGLIPTIN 5 MG
Affected / at Risk (%) Affected / at Risk (%)
Total   2/16 (12.50%)   1/20 (5.00%) 
Cardiac disorders     
ANGINA UNSTABLE  1  1/16 (6.25%)  0/20 (0.00%) 
General disorders     
CHEST DISCOMFORT  1  0/16 (0.00%)  1/20 (5.00%) 
Hepatobiliary disorders     
CHOLECYSTITIS  1  1/16 (6.25%)  0/20 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
COLON CANCER  1  1/16 (6.25%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PLACEBO/METFORMIN SAXAGLIPTIN 5 MG
Affected / at Risk (%) Affected / at Risk (%)
Total   14/16 (87.50%)   17/20 (85.00%) 
Blood and lymphatic system disorders     
ANAEMIA  1  0/16 (0.00%)  1/20 (5.00%) 
LYMPHOPENIA  1  0/16 (0.00%)  1/20 (5.00%) 
Cardiac disorders     
TACHYCARDIA  1  1/16 (6.25%)  0/20 (0.00%) 
Ear and labyrinth disorders     
VERTIGO  1  0/16 (0.00%)  1/20 (5.00%) 
MIDDLE EAR EFFUSION  1  0/16 (0.00%)  1/20 (5.00%) 
Eye disorders     
EYE IRRITATION  1  1/16 (6.25%)  0/20 (0.00%) 
LACRIMATION INCREASED  1  0/16 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders     
NAUSEA  1  3/16 (18.75%)  2/20 (10.00%) 
VOMITING  1  0/16 (0.00%)  1/20 (5.00%) 
DIARRHOEA  1  1/16 (6.25%)  2/20 (10.00%) 
DYSPEPSIA  1  0/16 (0.00%)  1/20 (5.00%) 
GASTRITIS  1  0/16 (0.00%)  2/20 (10.00%) 
FLATULENCE  1  2/16 (12.50%)  0/20 (0.00%) 
GASTRIC ULCER  1  0/16 (0.00%)  1/20 (5.00%) 
ABDOMINAL PAIN  1  2/16 (12.50%)  0/20 (0.00%) 
FAECES DISCOLOURED  1  0/16 (0.00%)  1/20 (5.00%) 
ABDOMINAL DISCOMFORT  1  2/16 (12.50%)  2/20 (10.00%) 
ABDOMINAL PAIN UPPER  1  0/16 (0.00%)  1/20 (5.00%) 
GASTROOESOPHAGEAL REFLUX DISEASE  1  0/16 (0.00%)  1/20 (5.00%) 
General disorders     
PAIN  1  1/16 (6.25%)  0/20 (0.00%) 
FATIGUE  1  2/16 (12.50%)  2/20 (10.00%) 
CHEST PAIN  1  1/16 (6.25%)  0/20 (0.00%) 
HERNIA PAIN  1  0/16 (0.00%)  1/20 (5.00%) 
CHEST DISCOMFORT  1  1/16 (6.25%)  0/20 (0.00%) 
OEDEMA PERIPHERAL  1  1/16 (6.25%)  2/20 (10.00%) 
INFUSION SITE PAIN  1  2/16 (12.50%)  4/20 (20.00%) 
INFUSION SITE DISCOMFORT  1  0/16 (0.00%)  1/20 (5.00%) 
Immune system disorders     
HYPERSENSITIVITY  1  1/16 (6.25%)  0/20 (0.00%) 
SEASONAL ALLERGY  1  1/16 (6.25%)  0/20 (0.00%) 
Infections and infestations     
CYSTITIS  1  0/16 (0.00%)  1/20 (5.00%) 
RHINITIS  1  0/16 (0.00%)  1/20 (5.00%) 
INFLUENZA  1  5/16 (31.25%)  0/20 (0.00%) 
SINUSITIS  1  0/16 (0.00%)  3/20 (15.00%) 
BRONCHITIS  1  1/16 (6.25%)  0/20 (0.00%) 
BACTERIURIA  1  0/16 (0.00%)  1/20 (5.00%) 
INFECTED CYST  1  1/16 (6.25%)  0/20 (0.00%) 
LABYRINTHITIS  1  0/16 (0.00%)  1/20 (5.00%) 
TOOTH ABSCESS  1  1/16 (6.25%)  0/20 (0.00%) 
OTITIS EXTERNA  1  1/16 (6.25%)  0/20 (0.00%) 
GASTROENTERITIS  1  0/16 (0.00%)  2/20 (10.00%) 
NASOPHARYNGITIS  1  3/16 (18.75%)  3/20 (15.00%) 
KIDNEY INFECTION  1  1/16 (6.25%)  0/20 (0.00%) 
GASTROENTERITIS VIRAL  1  1/16 (6.25%)  1/20 (5.00%) 
HELICOBACTER INFECTION  1  0/16 (0.00%)  1/20 (5.00%) 
URINARY TRACT INFECTION  1  1/16 (6.25%)  0/20 (0.00%) 
RESPIRATORY TRACT INFECTION  1  1/16 (6.25%)  0/20 (0.00%) 
VULVOVAGINAL MYCOTIC INFECTION  1  0/16 (0.00%)  1/20 (5.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  3/16 (18.75%)  3/20 (15.00%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  0/16 (0.00%)  1/20 (5.00%) 
Injury, poisoning and procedural complications     
LIMB INJURY  1  1/16 (6.25%)  0/20 (0.00%) 
MUSCLE STRAIN  1  0/16 (0.00%)  1/20 (5.00%) 
ANKLE FRACTURE  1  0/16 (0.00%)  1/20 (5.00%) 
HEAT EXHAUSTION  1  0/16 (0.00%)  1/20 (5.00%) 
PROCEDURAL PAIN  1  1/16 (6.25%)  0/20 (0.00%) 
ROAD TRAFFIC ACCIDENT  1  1/16 (6.25%)  1/20 (5.00%) 
POST PROCEDURAL SWELLING  1  0/16 (0.00%)  1/20 (5.00%) 
Investigations     
CARDIAC MURMUR  1  0/16 (0.00%)  1/20 (5.00%) 
URINE OUTPUT DECREASED  1  0/16 (0.00%)  1/20 (5.00%) 
BLOOD PRESSURE INCREASED  1  1/16 (6.25%)  0/20 (0.00%) 
EOSINOPHIL COUNT INCREASED  1  0/16 (0.00%)  1/20 (5.00%) 
LYMPHOCYTE COUNT DECREASED  1  0/16 (0.00%)  1/20 (5.00%) 
NEUTROPHIL COUNT DECREASED  1  0/16 (0.00%)  1/20 (5.00%) 
BLOOD CREATINE PHOSPHOKINASE INCREASED  1  1/16 (6.25%)  0/20 (0.00%) 
Metabolism and nutrition disorders     
HYPERLIPIDAEMIA  1  1/16 (6.25%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
MYALGIA  1  1/16 (6.25%)  1/20 (5.00%) 
BACK PAIN  1  2/16 (12.50%)  2/20 (10.00%) 
NECK PAIN  1  0/16 (0.00%)  1/20 (5.00%) 
ARTHRALGIA  1  1/16 (6.25%)  1/20 (5.00%) 
TENDONITIS  1  0/16 (0.00%)  1/20 (5.00%) 
MUSCLE SPASMS  1  0/16 (0.00%)  5/20 (25.00%) 
JOINT SWELLING  1  1/16 (6.25%)  0/20 (0.00%) 
PAIN IN EXTREMITY  1  0/16 (0.00%)  2/20 (10.00%) 
MUSCULOSKELETAL PAIN  1  2/16 (12.50%)  0/20 (0.00%) 
Nervous system disorders     
TREMOR  1  0/16 (0.00%)  1/20 (5.00%) 
AGEUSIA  1  0/16 (0.00%)  1/20 (5.00%) 
HEADACHE  1  3/16 (18.75%)  5/20 (25.00%) 
DIZZINESS  1  1/16 (6.25%)  0/20 (0.00%) 
DYSGEUSIA  1  0/16 (0.00%)  1/20 (5.00%) 
PRESYNCOPE  1  1/16 (6.25%)  0/20 (0.00%) 
PARAESTHESIA  1  0/16 (0.00%)  2/20 (10.00%) 
HYPOAESTHESIA  1  1/16 (6.25%)  1/20 (5.00%) 
SINUS HEADACHE  1  1/16 (6.25%)  0/20 (0.00%) 
NEUROPATHY PERIPHERAL  1  0/16 (0.00%)  1/20 (5.00%) 
CARPAL TUNNEL SYNDROME  1  0/16 (0.00%)  1/20 (5.00%) 
Psychiatric disorders     
STRESS  1  0/16 (0.00%)  1/20 (5.00%) 
INSOMNIA  1  1/16 (6.25%)  0/20 (0.00%) 
AGITATION  1  0/16 (0.00%)  1/20 (5.00%) 
Renal and urinary disorders     
BLADDER DILATATION  1  0/16 (0.00%)  1/20 (5.00%) 
Reproductive system and breast disorders     
PROSTATITIS  1  1/16 (6.25%)  0/20 (0.00%) 
GYNAECOMASTIA  1  0/16 (0.00%)  1/20 (5.00%) 
TESTICULAR PAIN  1  0/16 (0.00%)  1/20 (5.00%) 
UTERINE PROLAPSE  1  0/16 (0.00%)  1/20 (5.00%) 
ENDOMETRIAL HYPERTROPHY  1  1/16 (6.25%)  0/20 (0.00%) 
PROSTATIC CALCIFICATION  1  0/16 (0.00%)  1/20 (5.00%) 
BENIGN PROSTATIC HYPERPLASIA  1  0/16 (0.00%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders     
COUGH  1  3/16 (18.75%)  0/20 (0.00%) 
ASTHMA  1  1/16 (6.25%)  0/20 (0.00%) 
SINUS CONGESTION  1  2/16 (12.50%)  0/20 (0.00%) 
OROPHARYNGEAL PAIN  1  1/16 (6.25%)  1/20 (5.00%) 
SLEEP APNOEA SYNDROME  1  0/16 (0.00%)  1/20 (5.00%) 
Skin and subcutaneous tissue disorders     
RASH  1  0/16 (0.00%)  2/20 (10.00%) 
ERYTHEMA  1  1/16 (6.25%)  0/20 (0.00%) 
URTICARIA  1  0/16 (0.00%)  1/20 (5.00%) 
SKIN LESION  1  2/16 (12.50%)  0/20 (0.00%) 
RASH GENERALISED  1  0/16 (0.00%)  1/20 (5.00%) 
Vascular disorders     
HAEMATOMA  1  1/16 (6.25%)  0/20 (0.00%) 
HOT FLUSH  1  1/16 (6.25%)  0/20 (0.00%) 
HYPERTENSION  1  2/16 (12.50%)  0/20 (0.00%) 
PERIPHERAL COLDNESS  1  1/16 (6.25%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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
Layout table for Results Point of Contact information
Name/Title: Boaz Hirschberg
Organization: AstraZeneca Pharmaceuticals
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00374907     History of Changes
Other Study ID Numbers: CV181-041
First Submitted: September 7, 2006
First Posted: September 12, 2006
Results First Submitted: December 26, 2010
Results First Posted: January 21, 2011
Last Update Posted: May 7, 2015