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Trial record 2 of 6 for:    "Hyperthyroidism" | "Calcium"

Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

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: NCT01181531
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : April 25, 2014
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hyperparathyroidism, Secondary
Interventions Drug: Traditional Vitamin D Therapy
Drug: Cinacalcet
Enrollment 312
Recruitment Details Participants were enrolled from 08 September 2010 through 14 August 2012 Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.
Pre-assignment Details  
Arm/Group Title Traditional Vitamin D Cinacalcet
Hide Arm/Group Description Vitamin D sterol, intravenous (IV) or oral Cinacalcet Hydrochloride (Sensipar)
Period Title: Overall Study
Started 157 [1] 155 [1]
Received Investigational Product 155 153
Completed 96 102
Not Completed 61 53
Reason Not Completed
Other             17             12
Partial consent by subject withdrawn             0             1
Physician Decision             3             1
Noncompliance             2             2
Ineligibility determined             1             2
Protocol Specified Criteria             15             8
Pregnancy             0             1
Withdrawal by Subject             8             7
Protocol Violation             6             6
Death             9             12
Adverse Event             0             1
[1]
Subjects are randomized after washout.
Arm/Group Title Traditional Vitamin D Cinacalcet Total
Hide Arm/Group Description Vitamin D sterol, intravenous (IV) or oral Cinacalcet Hydrochloride (Sensipar) Total of all reporting groups
Overall Number of Baseline Participants 157 155 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants 155 participants 312 participants
54.3  (13.9) 53.5  (14.5) 53.9  (14.2)
[1]
Measure Description: All Enrolled subjects
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 155 participants 312 participants
Female
62
  39.5%
62
  40.0%
124
  39.7%
Male
95
  60.5%
93
  60.0%
188
  60.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 155 participants 312 participants
Hispanic or Latino
47
  29.9%
32
  20.6%
79
  25.3%
Not Hispanic or Latino
110
  70.1%
123
  79.4%
233
  74.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 157 participants 155 participants 312 participants
American Indian or Alaska Native 1 0 1
Asian 4 8 12
Native Hawaiian or Other Pacific Islander 1 0 1
Black or African American 60 76 136
White 86 66 152
More than one race 4 5 9
Unknown or Not Reported 1 0 1
1.Primary Outcome
Title Percent Change From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
Hide Description Mean PTH during EAP is defined as the mean of values at study weeks 40, 44, 48 and 52
Time Frame Baseline to week 40-52
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized by treatment arm.
Arm/Group Title Traditional Vitamin D Cinacalcet
Hide Arm/Group Description:
Vitamin D sterol, intravenous (IV) or oral
Cinacalcet Hydrochloride
Overall Number of Participants Analyzed 157 155
Least Squares Mean (Standard Error)
Unit of Measure: Percent change
-7  (4.0) -12.1  (4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Traditional Vitamin D, Cinacalcet
Comments Null hypothesis: no difference in % change from baseline in PTH comparing the two treatment arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.346
Comments Unadjusted. Model contains baseline stratification factor for type of Vitamin D administered at the site
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.0
Confidence Interval (2-Sided) 95%
-15.4 to 5.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.3
Estimation Comments Cinacalcet - Vitamin D
2.Secondary Outcome
Title Treatment Comparison of >=30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase (EAP)
Hide Description Number of participants achieving a >=30% Reduction From Baseline in Mean PTH During Efficacy Assessment Phase (EAP)
Time Frame Baseline to week 40-52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Traditional Vitamin D Cinacalcet
Hide Arm/Group Description:
Vitamin D sterol, intravenous (IV) or oral
Cinacalcet Hydrochloride
Overall Number of Participants Analyzed 157 155
Measure Type: Number
Unit of Measure: Participants
Yes 53 66
No 104 89
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Traditional Vitamin D, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments Stratified by type of Vitamin D at site
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
0.92 to 2.29
Estimation Comments OR is Cinacalcet: Vitamin D
3.Secondary Outcome
Title Treatment Comparison of Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)
Hide Description Number of participants achieving Plasma PTH < 300 pg/mL During Efficacy Assessment Phase (EAP)
Time Frame week 40-52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Traditional Vitamin D Cinacalcet
Hide Arm/Group Description:
Vitamin D sterol, intravenous (IV) or oral
Cinacalcet Hydrochloride
Overall Number of Participants Analyzed 157 155
Measure Type: Number
Unit of Measure: Participants
Yes 24 30
No 133 125
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Traditional Vitamin D, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.346
Comments stratified by type of Vitamin D at site
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.74 to 2.39
Estimation Comments OR is Cinacalcet: Vitamin D
Time Frame 56 weeks
Adverse Event Reporting Description

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Two participants in each arm did not receive Investigational Product (IP) and Traditional Vitamin D.

 
Arm/Group Title Traditional Vitamin D Cinacalcet
Hide Arm/Group Description Vitamin D sterol, intravenous (IV) or oral Cinacalcet Hydrochloride (Sensipar)
All-Cause Mortality
Traditional Vitamin D Cinacalcet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Traditional Vitamin D Cinacalcet
Affected / at Risk (%) Affected / at Risk (%)
Total   68/155 (43.87%)   60/153 (39.22%) 
Blood and lymphatic system disorders     
Anaemia  1  1/155 (0.65%)  1/153 (0.65%) 
Cardiac disorders     
Acute coronary syndrome  1  0/155 (0.00%)  1/153 (0.65%) 
Acute myocardial infarction  1  2/155 (1.29%)  3/153 (1.96%) 
Angina pectoris  1  2/155 (1.29%)  0/153 (0.00%) 
Arrhythmia  1  0/155 (0.00%)  1/153 (0.65%) 
Atrial fibrillation  1  3/155 (1.94%)  2/153 (1.31%) 
Atrial flutter  1  1/155 (0.65%)  0/153 (0.00%) 
Atrioventricular block  1  0/155 (0.00%)  1/153 (0.65%) 
Atrioventricular block complete  1  1/155 (0.65%)  0/153 (0.00%) 
Atrioventricular block second degree  1  1/155 (0.65%)  0/153 (0.00%) 
Bradycardia  1  0/155 (0.00%)  1/153 (0.65%) 
Cardiac arrest  1  2/155 (1.29%)  2/153 (1.31%) 
Cardiac discomfort  1  0/155 (0.00%)  1/153 (0.65%) 
Cardiac failure  1  1/155 (0.65%)  0/153 (0.00%) 
Cardiac failure congestive  1  4/155 (2.58%)  3/153 (1.96%) 
Cardio-respiratory arrest  1  0/155 (0.00%)  1/153 (0.65%) 
Coronary artery disease  1  0/155 (0.00%)  1/153 (0.65%) 
Myocardial infarction  1  0/155 (0.00%)  2/153 (1.31%) 
Nodal arrhythmia  1  0/155 (0.00%)  1/153 (0.65%) 
Supraventricular tachycardia  1  1/155 (0.65%)  0/153 (0.00%) 
Ventricular fibrillation  1  0/155 (0.00%)  1/153 (0.65%) 
Ventricular tachycardia  1  1/155 (0.65%)  0/153 (0.00%) 
Eye disorders     
Vitreous haemorrhage  1  1/155 (0.65%)  0/153 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/155 (0.00%)  1/153 (0.65%) 
Ascites  1  0/155 (0.00%)  1/153 (0.65%) 
Colonic polyp  1  0/155 (0.00%)  1/153 (0.65%) 
Diabetic gastroparesis  1  0/155 (0.00%)  1/153 (0.65%) 
Diarrhoea  1  0/155 (0.00%)  1/153 (0.65%) 
Diverticulum intestinal haemorrhagic  1  1/155 (0.65%)  0/153 (0.00%) 
Duodenal ulcer  1  0/155 (0.00%)  1/153 (0.65%) 
Duodenal ulcer haemorrhage  1  1/155 (0.65%)  0/153 (0.00%) 
Gastritis  1  1/155 (0.65%)  2/153 (1.31%) 
Gastritis haemorrhagic  1  0/155 (0.00%)  1/153 (0.65%) 
Gastrointestinal haemorrhage  1  1/155 (0.65%)  0/153 (0.00%) 
Gastrointestinal inflammation  1  0/155 (0.00%)  1/153 (0.65%) 
Haemorrhoidal haemorrhage  1  0/155 (0.00%)  1/153 (0.65%) 
Ileus paralytic  1  1/155 (0.65%)  0/153 (0.00%) 
Impaired gastric emptying  1  1/155 (0.65%)  2/153 (1.31%) 
Intestinal ischaemia  1  0/155 (0.00%)  1/153 (0.65%) 
Intestinal obstruction  1  1/155 (0.65%)  1/153 (0.65%) 
Lower gastrointestinal haemorrhage  1  0/155 (0.00%)  1/153 (0.65%) 
Mallory-Weiss syndrome  1  0/155 (0.00%)  1/153 (0.65%) 
Nausea  1  0/155 (0.00%)  2/153 (1.31%) 
Pancreatitis  1  0/155 (0.00%)  1/153 (0.65%) 
Pancreatitis chronic  1  1/155 (0.65%)  1/153 (0.65%) 
Upper gastrointestinal haemorrhage  1  1/155 (0.65%)  1/153 (0.65%) 
Vomiting  1  0/155 (0.00%)  1/153 (0.65%) 
General disorders     
Chest pain  1  0/155 (0.00%)  3/153 (1.96%) 
Chills  1  0/155 (0.00%)  1/153 (0.65%) 
Death  1  2/155 (1.29%)  1/153 (0.65%) 
Non-cardiac chest pain  1  1/155 (0.65%)  4/153 (2.61%) 
Oedema peripheral  1  0/155 (0.00%)  1/153 (0.65%) 
Pyrexia  1  0/155 (0.00%)  1/153 (0.65%) 
Sudden cardiac death  1  0/155 (0.00%)  1/153 (0.65%) 
Sudden death  1  0/155 (0.00%)  1/153 (0.65%) 
Thrombosis in device  1  0/155 (0.00%)  1/153 (0.65%) 
Hepatobiliary disorders     
Cholecystitis  1  0/155 (0.00%)  2/153 (1.31%) 
Cholecystitis acute  1  0/155 (0.00%)  1/153 (0.65%) 
Cholecystitis chronic  1  0/155 (0.00%)  1/153 (0.65%) 
Cholelithiasis  1  0/155 (0.00%)  1/153 (0.65%) 
Infections and infestations     
Acute tonsillitis  1  0/155 (0.00%)  1/153 (0.65%) 
Arteriovenous fistula site infection  1  2/155 (1.29%)  1/153 (0.65%) 
Arteriovenous graft site infection  1  0/155 (0.00%)  1/153 (0.65%) 
Bronchitis  1  3/155 (1.94%)  1/153 (0.65%) 
Cellulitis  1  2/155 (1.29%)  0/153 (0.00%) 
Device related infection  1  1/155 (0.65%)  0/153 (0.00%) 
Device related sepsis  1  1/155 (0.65%)  1/153 (0.65%) 
Diabetic gangrene  1  1/155 (0.65%)  0/153 (0.00%) 
Gangrene  1  2/155 (1.29%)  1/153 (0.65%) 
Gastroenteritis  1  1/155 (0.65%)  0/153 (0.00%) 
Intervertebral discitis  1  0/155 (0.00%)  1/153 (0.65%) 
Labyrinthitis  1  0/155 (0.00%)  1/153 (0.65%) 
Lobar pneumonia  1  1/155 (0.65%)  0/153 (0.00%) 
Localised infection  1  1/155 (0.65%)  0/153 (0.00%) 
Osteomyelitis  1  1/155 (0.65%)  0/153 (0.00%) 
Pneumonia  1  7/155 (4.52%)  2/153 (1.31%) 
Sepsis  1  2/155 (1.29%)  3/153 (1.96%) 
Sepsis syndrome  1  0/155 (0.00%)  1/153 (0.65%) 
Septic shock  1  1/155 (0.65%)  0/153 (0.00%) 
Staphylococcal bacteraemia  1  1/155 (0.65%)  2/153 (1.31%) 
Staphylococcal sepsis  1  1/155 (0.65%)  1/153 (0.65%) 
Urinary tract infection pseudomonal  1  1/155 (0.65%)  0/153 (0.00%) 
Urosepsis  1  1/155 (0.65%)  0/153 (0.00%) 
Wound infection  1  0/155 (0.00%)  1/153 (0.65%) 
Injury, poisoning and procedural complications     
Arteriovenous fistula occlusion  1  2/155 (1.29%)  0/153 (0.00%) 
Arteriovenous fistula site complication  1  1/155 (0.65%)  0/153 (0.00%) 
Arteriovenous fistula thrombosis  1  4/155 (2.58%)  1/153 (0.65%) 
Arteriovenous graft aneurysm  1  0/155 (0.00%)  1/153 (0.65%) 
Arteriovenous graft site haemorrhage  1  0/155 (0.00%)  1/153 (0.65%) 
Arthropod sting  1  0/155 (0.00%)  1/153 (0.65%) 
Cervical vertebral fracture  1  1/155 (0.65%)  0/153 (0.00%) 
Hand fracture  1  1/155 (0.65%)  1/153 (0.65%) 
Lower limb fracture  1  1/155 (0.65%)  0/153 (0.00%) 
Pelvic fracture  1  1/155 (0.65%)  0/153 (0.00%) 
Post procedural haemorrhage  1  0/155 (0.00%)  1/153 (0.65%) 
Rib fracture  1  0/155 (0.00%)  1/153 (0.65%) 
Upper limb fracture  1  1/155 (0.65%)  0/153 (0.00%) 
Vascular access complication  1  2/155 (1.29%)  0/153 (0.00%) 
Vascular pseudoaneurysm  1  1/155 (0.65%)  0/153 (0.00%) 
Investigations     
Haemoglobin decreased  1  1/155 (0.65%)  0/153 (0.00%) 
Hepatic enzyme increased  1  0/155 (0.00%)  1/153 (0.65%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  0/155 (0.00%)  2/153 (1.31%) 
Fluid overload  1  5/155 (3.23%)  7/153 (4.58%) 
Hyperkalaemia  1  1/155 (0.65%)  5/153 (3.27%) 
Hypocalcaemia  1  0/155 (0.00%)  1/153 (0.65%) 
Hypoglycaemia  1  2/155 (1.29%)  2/153 (1.31%) 
Hypophosphataemia  1  0/155 (0.00%)  1/153 (0.65%) 
Hypovolaemia  1  0/155 (0.00%)  1/153 (0.65%) 
Musculoskeletal and connective tissue disorders     
Muscle haemorrhage  1  0/155 (0.00%)  1/153 (0.65%) 
Musculoskeletal chest pain  1  0/155 (0.00%)  1/153 (0.65%) 
Musculoskeletal pain  1  0/155 (0.00%)  1/153 (0.65%) 
Osteoarthritis  1  0/155 (0.00%)  1/153 (0.65%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer  1  0/155 (0.00%)  1/153 (0.65%) 
Endometrial cancer metastatic  1  0/155 (0.00%)  1/153 (0.65%) 
Renal cell carcinoma  1  0/155 (0.00%)  1/153 (0.65%) 
Uterine leiomyoma  1  1/155 (0.65%)  0/153 (0.00%) 
Nervous system disorders     
Ataxia  1  1/155 (0.65%)  0/153 (0.00%) 
Cerebrovascular accident  1  1/155 (0.65%)  0/153 (0.00%) 
Convulsion  1  1/155 (0.65%)  0/153 (0.00%) 
Hemiparesis  1  0/155 (0.00%)  1/153 (0.65%) 
Hypertensive encephalopathy  1  1/155 (0.65%)  1/153 (0.65%) 
Hypoaesthesia  1  1/155 (0.65%)  0/153 (0.00%) 
Intracranial aneurysm  1  1/155 (0.65%)  0/153 (0.00%) 
Presyncope  1  1/155 (0.65%)  0/153 (0.00%) 
Syncope  1  0/155 (0.00%)  2/153 (1.31%) 
Toxic encephalopathy  1  1/155 (0.65%)  0/153 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  0/155 (0.00%)  1/153 (0.65%) 
Renal and urinary disorders     
Azotaemia  1  1/155 (0.65%)  0/153 (0.00%) 
Renal failure chronic  1  1/155 (0.65%)  0/153 (0.00%) 
Renal mass  1  0/155 (0.00%)  1/153 (0.65%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/155 (0.65%)  0/153 (0.00%) 
Asthma  1  0/155 (0.00%)  1/153 (0.65%) 
Chronic obstructive pulmonary disease  1  2/155 (1.29%)  1/153 (0.65%) 
Dyspnoea  1  3/155 (1.94%)  3/153 (1.96%) 
Pleural effusion  1  1/155 (0.65%)  0/153 (0.00%) 
Pleuritic pain  1  0/155 (0.00%)  1/153 (0.65%) 
Pneumonia aspiration  1  1/155 (0.65%)  1/153 (0.65%) 
Pulmonary embolism  1  2/155 (1.29%)  0/153 (0.00%) 
Pulmonary oedema  1  3/155 (1.94%)  1/153 (0.65%) 
Respiratory depression  1  0/155 (0.00%)  1/153 (0.65%) 
Respiratory distress  1  1/155 (0.65%)  0/153 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin ulcer  1  1/155 (0.65%)  0/153 (0.00%) 
Surgical and medical procedures     
Abdominal hernia repair  1  1/155 (0.65%)  0/153 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  0/155 (0.00%)  1/153 (0.65%) 
Hypertension  1  0/155 (0.00%)  1/153 (0.65%) 
Hypertensive crisis  1  1/155 (0.65%)  0/153 (0.00%) 
Hypertensive emergency  1  0/155 (0.00%)  2/153 (1.31%) 
Hypotension  1  1/155 (0.65%)  3/153 (1.96%) 
Ischaemic limb pain  1  1/155 (0.65%)  0/153 (0.00%) 
Peripheral ischaemia  1  2/155 (1.29%)  0/153 (0.00%) 
Superior vena cava syndrome  1  0/155 (0.00%)  1/153 (0.65%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Traditional Vitamin D Cinacalcet
Affected / at Risk (%) Affected / at Risk (%)
Total   83/155 (53.55%)   98/153 (64.05%) 
Blood and lymphatic system disorders     
Anaemia  1  5/155 (3.23%)  4/153 (2.61%) 
Endocrine disorders     
Hyperparathyroidism  1  5/155 (3.23%)  2/153 (1.31%) 
Gastrointestinal disorders     
Abdominal pain  1  1/155 (0.65%)  5/153 (3.27%) 
Constipation  1  7/155 (4.52%)  8/153 (5.23%) 
Diarrhoea  1  16/155 (10.32%)  15/153 (9.80%) 
Nausea  1  10/155 (6.45%)  27/153 (17.65%) 
Vomiting  1  5/155 (3.23%)  16/153 (10.46%) 
General disorders     
Asthenia  1  1/155 (0.65%)  7/153 (4.58%) 
Chest pain  1  5/155 (3.23%)  6/153 (3.92%) 
Oedema  1  5/155 (3.23%)  2/153 (1.31%) 
Oedema peripheral  1  5/155 (3.23%)  8/153 (5.23%) 
Pain  1  2/155 (1.29%)  6/153 (3.92%) 
Pyrexia  1  8/155 (5.16%)  3/153 (1.96%) 
Infections and infestations     
Urinary tract infection  1  3/155 (1.94%)  5/153 (3.27%) 
Injury, poisoning and procedural complications     
Arteriovenous fistula site complication  1  7/155 (4.52%)  8/153 (5.23%) 
Fall  1  4/155 (2.58%)  7/153 (4.58%) 
Procedural hypotension  1  7/155 (4.52%)  4/153 (2.61%) 
Vascular graft thrombosis  1  4/155 (2.58%)  6/153 (3.92%) 
Metabolism and nutrition disorders     
Decreased appetite  1  5/155 (3.23%)  3/153 (1.96%) 
Fluid overload  1  8/155 (5.16%)  2/153 (1.31%) 
Hypercalcaemia  1  7/155 (4.52%)  1/153 (0.65%) 
Hyperkalaemia  1  4/155 (2.58%)  6/153 (3.92%) 
Hyperphosphataemia  1  7/155 (4.52%)  3/153 (1.96%) 
Hypocalcaemia  1  2/155 (1.29%)  26/153 (16.99%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/155 (4.52%)  6/153 (3.92%) 
Back pain  1  7/155 (4.52%)  3/153 (1.96%) 
Muscle spasms  1  14/155 (9.03%)  12/153 (7.84%) 
Pain in extremity  1  6/155 (3.87%)  10/153 (6.54%) 
Nervous system disorders     
Dizziness  1  5/155 (3.23%)  7/153 (4.58%) 
Headache  1  4/155 (2.58%)  8/153 (5.23%) 
Psychiatric disorders     
Anxiety  1  8/155 (5.16%)  4/153 (2.61%) 
Insomnia  1  6/155 (3.87%)  8/153 (5.23%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  10/155 (6.45%)  9/153 (5.88%) 
Dyspnoea  1  8/155 (5.16%)  17/153 (11.11%) 
Vascular disorders     
Hypertension  1  7/155 (4.52%)  8/153 (5.23%) 
Hypotension  1  6/155 (3.87%)  9/153 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
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.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01181531    
Other Study ID Numbers: 20090686
PARADIGM ( Other Identifier: Amgen )
First Submitted: August 12, 2010
First Posted: August 13, 2010
Results First Submitted: December 3, 2013
Results First Posted: April 25, 2014
Last Update Posted: October 17, 2018