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Trial record 55 of 112 for:    CALCIUM CATION

Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis

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: NCT02138838
Recruitment Status : Terminated (Amgen decided to terminate the study early to be able to meet US regulatory timelines fo filing. Subjects in treatment were rolled over to the 20140159 study.)
First Posted : May 15, 2014
Results First Posted : September 14, 2017
Last Update Posted : June 17, 2019
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 Chronic Kidney Disease, Secondary Hyperparathyroidism
Interventions Drug: Cinacalcet HCl
Dietary Supplement: Standard of Care
Enrollment 55
Recruitment Details This study was conducted at 32 centers in Belgium, Czech Republic, France, Germany, Greece, Hungary, Lithuania, Poland, Portugal, Russia Federation, Slovakia, Spain, Ukraine, and the United States.
Pre-assignment Details Eligible participants were randomized to 1 of 2 treatment groups in a 1:1 ratio: cinacalcet daily in addition to standard of care (SOC) therapy or SOC therapy alone. Randomization was stratified by age group (6 to < 12 and 12 to < 18 years). Participants remained on treatment for 20 weeks or until the time of renal transplant or parathyroidectomy.
Arm/Group Title Standard of Care Cinacalcet
Hide Arm/Group Description Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders. In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Period Title: Overall Study
Started 28 27
Received Study Drug 28 25
Completed 20 16
Not Completed 8 11
Reason Not Completed
Study Closure             7             6
Withdrawal by Subject             1             5
Arm/Group Title Standard of Care Cinacalcet Total
Hide Arm/Group Description Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders. In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels. Total of all reporting groups
Overall Number of Baseline Participants 28 27 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 27 participants 55 participants
12.4  (3.5) 12.8  (3.9) 12.6  (3.6)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
6 to < 12 years 9 9 18
12 to < 18 years 19 18 37
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
Female
15
  53.6%
12
  44.4%
27
  49.1%
Male
13
  46.4%
15
  55.6%
28
  50.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
Black (or African American) 4 5 9
White 23 19 42
Mixed Race 0 1 1
Other 1 2 3
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 55 participants
Hispanic/Latino 4 0 4
Not Hispanic/Latino 24 27 51
Intact Parathyroid Hormone Level  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 28 participants 27 participants 55 participants
1228.43  (732.08) 945.72  (635.35) 1092.31  (695.53)
1.Primary Outcome
Title Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15
Hide Description

Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated.

This endpoint was the primary endpoint in the US only.

Time Frame Baseline and weeks 11 to 15
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was conducted using the full analysis set; participants who had no week 11 or 15 iPTH values were considered non-responders (non-responder imputation).
Arm/Group Title Standard of Care Cinacalcet
Hide Arm/Group Description:
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Overall Number of Participants Analyzed 28 27
Measure Type: Number
Unit of Measure: percentage of participants
17.9 25.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test stratified by baseline age group
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
-13.7 to 29.9
Estimation Comments SOC+Cinacalcet - SOC
2.Primary Outcome
Title Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period
Hide Description

Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated.

This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint.

Time Frame Baseline and the efficacy assessment period (EAP), weeks 17 to 20
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (all randomized participants) was used for this analysis. For participants with no iPTH values in the EAP, the mean of the last 2 available postbaseline values was used. If only 1 postbaseline value was available, this value was used. If no postbaseline value was available, the participant was considered a non-responder.
Arm/Group Title Standard of Care Cinacalcet
Hide Arm/Group Description:
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Overall Number of Participants Analyzed 28 27
Measure Type: Number
Unit of Measure: percentage of participants
32.1 22.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Cinacalcet
Comments A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints. The primary endpoint was tested at a 2-sided significance level of 0.05. The secondary endpoints were tested using Holm’s method at 0.05 (2-sided) should the primary endpoint achieve a significant result.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel stratified by baseline age group (6-<12 years, 12-<18 years)
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value -9.9
Confidence Interval (2-Sided) 95%
-33.3 to 13.4
Estimation Comments SOC+Cinacalcet - SOC
3.Secondary Outcome
Title Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20
Hide Description [Not Specified]
Time Frame Efficacy assessment period, weeks 17 to 20
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was conducted using the full analysis set. For participants with no iPTH values in the EAP, the mean of the last 2 available postbaseline values was used. If only 1 postbaseline value was available, this value was used. If no postbaseline value was available, the participant was considered a non-responder.
Arm/Group Title Standard of Care Cinacalcet
Hide Arm/Group Description:
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Overall Number of Participants Analyzed 28 27
Measure Type: Number
Unit of Measure: percentage of participants
17.9 7.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test stratified by baseline age group
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value -10.4
Confidence Interval (2-Sided) 95%
-27.7 to 6.8
Estimation Comments SOC+Cinacalcet - SOC
4.Secondary Outcome
Title Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20
Hide Description [Not Specified]
Time Frame Baseline and weeks 17 to 20
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.
Arm/Group Title Standard of Care Cinacalcet
Hide Arm/Group Description:
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Overall Number of Participants Analyzed 27 24
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-11.3  (11.10) 7.7  (11.73)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance (ANCOVA) with baseline age group as the covariate.
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 19.0
Confidence Interval (2-Sided) 95%
-12.5 to 50.5
Estimation Comments SOC+Cinacalcet - SOC
5.Secondary Outcome
Title Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20
Hide Description [Not Specified]
Time Frame Baseline and weeks 17 to 20
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.
Arm/Group Title Standard of Care Cinacalcet
Hide Arm/Group Description:
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Overall Number of Participants Analyzed 28 24
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
0.06  (0.126) -0.28  (0.135)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance (ANCOVA) with baseline age group as the covariate.
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.70 to 0.01
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20
Hide Description [Not Specified]
Time Frame Baseline and weeks 17 to 20
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.
Arm/Group Title Standard of Care Cinacalcet
Hide Arm/Group Description:
Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
Overall Number of Participants Analyzed 26 24
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-0.09  (0.258) 0.67  (0.266)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard of Care, Cinacalcet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method ANCOVA
Comments Analysis of covariance (ANCOVA) with baseline age group as the covariate.
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.04 to 1.48
Estimation Comments SOC+Cinacalcet - SOC
Time Frame 24 Weeks
Adverse Event Reporting Description

Two participants who were randomized to the cinacalcet group but did not receive cinacalcet were included in the Standard of Care group for safety analysis.

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

 
Arm/Group Title Standard of Care Cinacalcet
Hide Arm/Group Description Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders. In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
All-Cause Mortality
Standard of Care Cinacalcet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Standard of Care Cinacalcet
Affected / at Risk (%) Affected / at Risk (%)
Total   2/30 (6.67%)   4/25 (16.00%) 
Gastrointestinal disorders     
Ileus  1  0/30 (0.00%)  1/25 (4.00%) 
Infections and infestations     
Bacterial infection  1  1/30 (3.33%)  0/25 (0.00%) 
Device related infection  1  0/30 (0.00%)  1/25 (4.00%) 
Peritonitis  1  0/30 (0.00%)  1/25 (4.00%) 
Postoperative wound infection  1  0/30 (0.00%)  1/25 (4.00%) 
Soft tissue infection  1  0/30 (0.00%)  1/25 (4.00%) 
Injury, poisoning and procedural complications     
Arteriovenous fistula site haemorrhage  1  0/30 (0.00%)  1/25 (4.00%) 
Metabolism and nutrition disorders     
Fluid overload  1  0/30 (0.00%)  1/25 (4.00%) 
Product Issues     
Device dislocation  1  0/30 (0.00%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/30 (3.33%)  0/25 (0.00%) 
Dyspnoea  1  0/30 (0.00%)  1/25 (4.00%) 
Vascular disorders     
Renovascular hypertension  1  0/30 (0.00%)  1/25 (4.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard of Care Cinacalcet
Affected / at Risk (%) Affected / at Risk (%)
Total   17/30 (56.67%)   20/25 (80.00%) 
Blood and lymphatic system disorders     
Nephrogenic anaemia  1  1/30 (3.33%)  1/25 (4.00%) 
Cardiac disorders     
Palpitations  1  1/30 (3.33%)  0/25 (0.00%) 
Ear and labyrinth disorders     
Motion sickness  1  1/30 (3.33%)  0/25 (0.00%) 
Endocrine disorders     
Precocious puberty  1  1/30 (3.33%)  0/25 (0.00%) 
Eye disorders     
Eyelid oedema  1  1/30 (3.33%)  0/25 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/30 (3.33%)  1/25 (4.00%) 
Abdominal pain upper  1  2/30 (6.67%)  1/25 (4.00%) 
Diarrhoea  1  2/30 (6.67%)  1/25 (4.00%) 
Gastrooesophageal reflux disease  1  1/30 (3.33%)  1/25 (4.00%) 
Lip blister  1  1/30 (3.33%)  0/25 (0.00%) 
Nausea  1  1/30 (3.33%)  3/25 (12.00%) 
Vomiting  1  3/30 (10.00%)  0/25 (0.00%) 
General disorders     
Chills  1  0/30 (0.00%)  1/25 (4.00%) 
Influenza like illness  1  0/30 (0.00%)  1/25 (4.00%) 
Malaise  1  1/30 (3.33%)  0/25 (0.00%) 
Pyrexia  1  1/30 (3.33%)  1/25 (4.00%) 
Vessel puncture site pain  1  0/30 (0.00%)  1/25 (4.00%) 
Infections and infestations     
Bronchitis bacterial  1  0/30 (0.00%)  1/25 (4.00%) 
Cellulitis  1  0/30 (0.00%)  1/25 (4.00%) 
Ear infection  1  0/30 (0.00%)  1/25 (4.00%) 
Gastroenteritis  1  0/30 (0.00%)  2/25 (8.00%) 
Gastrointestinal infection  1  0/30 (0.00%)  1/25 (4.00%) 
Hepatitis B  1  0/30 (0.00%)  1/25 (4.00%) 
Lip infection  1  0/30 (0.00%)  1/25 (4.00%) 
Nasopharyngitis  1  2/30 (6.67%)  2/25 (8.00%) 
Peritonitis  1  0/30 (0.00%)  1/25 (4.00%) 
Pneumonia  1  0/30 (0.00%)  2/25 (8.00%) 
Respiratory tract infection  1  0/30 (0.00%)  1/25 (4.00%) 
Respiratory tract infection viral  1  0/30 (0.00%)  1/25 (4.00%) 
Rhinitis  1  1/30 (3.33%)  1/25 (4.00%) 
Sinusitis  1  0/30 (0.00%)  1/25 (4.00%) 
Urinary tract infection  1  1/30 (3.33%)  0/25 (0.00%) 
Viral pharyngitis  1  1/30 (3.33%)  0/25 (0.00%) 
Injury, poisoning and procedural complications     
Arteriovenous fistula site complication  1  1/30 (3.33%)  1/25 (4.00%) 
Ligament sprain  1  1/30 (3.33%)  0/25 (0.00%) 
Overdose  1  0/30 (0.00%)  1/25 (4.00%) 
Post procedural oedema  1  1/30 (3.33%)  0/25 (0.00%) 
Procedural headache  1  0/30 (0.00%)  1/25 (4.00%) 
Procedural pain  1  2/30 (6.67%)  0/25 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  0/30 (0.00%)  1/25 (4.00%) 
Blood alkaline phosphatase increased  1  1/30 (3.33%)  1/25 (4.00%) 
Blood calcium decreased  1  1/30 (3.33%)  1/25 (4.00%) 
Blood parathyroid hormone decreased  1  1/30 (3.33%)  0/25 (0.00%) 
Blood phosphorus decreased  1  1/30 (3.33%)  0/25 (0.00%) 
Blood phosphorus increased  1  0/30 (0.00%)  1/25 (4.00%) 
Blood pressure increased  1  1/30 (3.33%)  0/25 (0.00%) 
Weight increased  1  2/30 (6.67%)  0/25 (0.00%) 
Metabolism and nutrition disorders     
Hyperphosphataemia  1  0/30 (0.00%)  1/25 (4.00%) 
Hypocalcaemia  1  2/30 (6.67%)  6/25 (24.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/30 (3.33%)  0/25 (0.00%) 
Joint swelling  1  1/30 (3.33%)  0/25 (0.00%) 
Muscle spasms  1  2/30 (6.67%)  3/25 (12.00%) 
Myalgia  1  1/30 (3.33%)  0/25 (0.00%) 
Pain in extremity  1  2/30 (6.67%)  0/25 (0.00%) 
Nervous system disorders     
Dizziness postural  1  1/30 (3.33%)  0/25 (0.00%) 
Headache  1  4/30 (13.33%)  1/25 (4.00%) 
Hypoaesthesia  1  0/30 (0.00%)  1/25 (4.00%) 
Neurological symptom  1  0/30 (0.00%)  1/25 (4.00%) 
Paraesthesia  1  1/30 (3.33%)  1/25 (4.00%) 
Product Issues     
Device occlusion  1  1/30 (3.33%)  0/25 (0.00%) 
Renal and urinary disorders     
Haematuria  1  1/30 (3.33%)  0/25 (0.00%) 
Hypertonic bladder  1  1/30 (3.33%)  0/25 (0.00%) 
Reproductive system and breast disorders     
Breast mass  1  1/30 (3.33%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm  1  1/30 (3.33%)  0/25 (0.00%) 
Cough  1  1/30 (3.33%)  0/25 (0.00%) 
Dysphonia  1  1/30 (3.33%)  0/25 (0.00%) 
Epistaxis  1  0/30 (0.00%)  1/25 (4.00%) 
Nasal discharge discolouration  1  1/30 (3.33%)  0/25 (0.00%) 
Productive cough  1  1/30 (3.33%)  0/25 (0.00%) 
Rhinitis allergic  1  1/30 (3.33%)  0/25 (0.00%) 
Rhinorrhoea  1  1/30 (3.33%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders     
Acne  1  1/30 (3.33%)  0/25 (0.00%) 
Dermatitis atopic  1  1/30 (3.33%)  0/25 (0.00%) 
Rash  1  1/30 (3.33%)  0/25 (0.00%) 
Surgical and medical procedures     
Catheter placement  1  1/30 (3.33%)  1/25 (4.00%) 
Catheter removal  1  0/30 (0.00%)  1/25 (4.00%) 
Vascular disorders     
Hypertension  1  1/30 (3.33%)  1/25 (4.00%) 
Venous stenosis  1  1/30 (3.33%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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 after completion. 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
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02138838    
Other Study ID Numbers: 20130356
2013-004958-18 ( EudraCT Number )
First Submitted: April 1, 2014
First Posted: May 15, 2014
Results First Submitted: July 13, 2017
Results First Posted: September 14, 2017
Last Update Posted: June 17, 2019