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Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study (RUTHERFORD)

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ClinicalTrials.gov Identifier: NCT01375751
Recruitment Status : Completed
First Posted : June 17, 2011
Results First Posted : September 29, 2015
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypercholesterolemia, Familial
Interventions Biological: Evolocumab
Biological: Placebo
Enrollment 168
Recruitment Details

Men and women 18 to to 75 years of age, with a diagnosis of heterozygous familial hypercholesterolemia, fasting low-density lipoprotein cholesterol (LDL-C) of ≥ 100 mg/dL, and fasting triglycerides ≤ 400 mg/dL were eligible for this study.

The first patient was enrolled on 02 August 2011 and the last patient was enrolled on 20 February 2012.

Pre-assignment Details Randomization was stratified on the basis of screening LDL-C level (< 130 mg/dL [3.4 mmol/L] or ≥ 130 mg/dL) and ezetimibe use at baseline (yes or no).
Arm/Group Title Placebo Evolocumab 350 mg Evolocumab 420 mg
Hide Arm/Group Description Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks. Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Period Title: Overall Study
Started 56 56 56
Received Treatment 56 55 56
Completed 56 55 56
Not Completed 0 1 0
Reason Not Completed
Other             0             1             0
Arm/Group Title Placebo Evolocumab 350 mg Evolocumab 420 mg Total
Hide Arm/Group Description Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks. Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 56 55 56 167
Hide Baseline Analysis Population Description
Full analysis set (all randomized participants who received at least 1 dose of investigational product).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 55 participants 56 participants 167 participants
49.3  (11.3) 47.6  (13.6) 51.8  (13.0) 49.6  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 56 participants 167 participants
Female
32
  57.1%
25
  45.5%
21
  37.5%
78
  46.7%
Male
24
  42.9%
30
  54.5%
35
  62.5%
89
  53.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 56 participants 167 participants
Hispanic or Latino 2 0 0 2
Not Hispanic or Latino 54 55 56 165
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 56 participants 167 participants
Asian 3 1 3 7
Black or African American 0 3 1 4
White 48 48 52 148
Other 4 3 0 7
Mixed Race 1 0 0 1
Stratification Factor: LDL-C Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 56 participants 167 participants
< 130 mg/dL 19 17 19 55
≥ 130 mg/dL 37 38 37 112
Stratification Factor: Baseline Use Of Ezetimibe  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 56 participants 167 participants
No 20 19 20 59
Yes 36 36 36 108
LDL-C Concentration   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 56 participants 55 participants 56 participants 167 participants
160.8  (44.0) 156.8  (46.1) 149.5  (36.3) 155.7  (42.3)
[1]
Measure Description: LDL-C was measured using ultacentrifugation
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 56 participants 55 participants 56 participants 167 participants
182.7  (52.6) 178.0  (51.7) 171.0  (43.6) 177.2  (49.4)
Apolipoprotein B Concentration  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 56 participants 55 participants 56 participants 167 participants
125.2  (30.3) 120.9  (29.3) 119.3  (27.6) 121.8  (29.0)
Total Cholesterol/HDL-C Ratio  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 56 participants 55 participants 56 participants 167 participants
4.895  (1.790) 5.119  (1.923) 4.857  (1.688) 4.956  (1.795)
Apolipoprotein B/Apolipoprotein A1 Ratio  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 56 participants 55 participants 56 participants 167 participants
0.899  (0.277) 0.901  (0.286) 0.867  (0.264) 0.899  (0.274)
1.Primary Outcome
Title Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Hide Description LDL-C was measured using ultracentrifugation.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; Missing ultracentrifugation (UC) LDL-C data at Week 12 were imputed using last observation carried forward (LOCF) and calculated LDL-C.
Arm/Group Title Placebo Evolocumab 350 mg Evolocumab 420 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 56 55 56
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.12  (2.88) -42.70  (2.93) -55.24  (2.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab 350 mg
Comments The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method ANCOVA
Comments ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -43.82
Confidence Interval (2-Sided) 95%
-51.56 to -36.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.92
Estimation Comments Placebo is the reference.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab 420 mg
Comments The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method ANCOVA
Comments ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -56.36
Confidence Interval (2-Sided) 95%
-64.06 to -48.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.90
Estimation Comments Placebo is the reference
2.Secondary Outcome
Title Absolute Change From Baseline in LDL-C at Week 12
Hide Description LDL-C was measured using ultracentrifugation.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; LOCF imputation was used.
Arm/Group Title Placebo Evolocumab 350 mg Evolocumab 420 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 56 55 56
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
4.2  (5.2) -61.3  (5.4) -80.5  (5.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab 350 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method ANCOVA
Comments ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -65.5
Confidence Interval (2-Sided) 95%
-79.6 to -51.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.1
Estimation Comments Placebo is the reference
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab 420 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method ANCOVA
Comments ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -84.7
Confidence Interval (2-Sided) 95%
-98.8 to -70.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.1
Estimation Comments Placebo is the reference
3.Secondary Outcome
Title Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; LOCF imputation was used.
Arm/Group Title Placebo Evolocumab 350 mg Evolocumab 420 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 56 55 56
Least Squares Mean (Standard Error)
Unit of Measure: percent change
2.48  (2.80) -39.31  (2.86) -50.98  (2.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab 350 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method ANCOVA
Comments ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -41.79
Confidence Interval (2-Sided) 95%
-49.32 to -34.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.81
Estimation Comments Placebo is the reference
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab 420 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method ANCOVA
Comments ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -53.46
Confidence Interval (2-Sided) 95%
-60.95 to -45.97
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.79
Estimation Comments Placebo is the reference
4.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; LOCF imputation was used
Arm/Group Title Placebo Evolocumab 350 mg Evolocumab 420 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 56 55 56
Least Squares Mean (Standard Error)
Unit of Measure: percent change
2.86  (2.61) -31.89  (2.66) -43.34  (2.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab 350 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method ANCOVA
Comments ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -34.75
Confidence Interval (2-Sided) 95%
-41.77 to -27.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.55
Estimation Comments Placebo is the reference
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab 420 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method ANCOVA
Comments ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -46.20
Confidence Interval (2-Sided) 95%
-53.18 to -39.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.53
Estimation Comments Placebo is the reference
5.Secondary Outcome
Title Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; LOCF imputaton was used.
Arm/Group Title Placebo Evolocumab 350 mg Evolocumab 420 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 56 55 56
Least Squares Mean (Standard Error)
Unit of Measure: percent change
2.98  (2.73) -33.69  (2.79) -42.03  (2.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab 350 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method ANCOVA
Comments ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -36.66
Confidence Interval (2-Sided) 95%
-44.01 to -29.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.72
Estimation Comments Placbo is the reference
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab 420 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method ANCOVA
Comments ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -45.01
Confidence Interval (2-Sided) 95%
-52.32 to -37.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.70
Estimation Comments Placebo is the reference
6.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B /Apolipoprotein A-1 Ratio at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; LOCF imputation was used.
Arm/Group Title Placebo Evolocumab 350 mg Evolocumab 420 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Overall Number of Participants Analyzed 56 55 56
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-4.10  (2.53) -38.02  (2.58) -48.74  (2.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab 350 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method ANCOVA
Comments ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -33.92
Confidence Interval (2-Sided) 95%
-40.72 to -27.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.45
Estimation Comments Placebo is the reference
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab 420 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method ANCOVA
Comments ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -44.64
Confidence Interval (2-Sided) 95%
-51.41 to -37.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.43
Estimation Comments Placebo is the reference
Time Frame 12 weeks
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Placebo Evolocumab 350 mg Evolocumab 420 mg
Hide Arm/Group Description Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks. Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
All-Cause Mortality
Placebo Evolocumab 350 mg Evolocumab 420 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Evolocumab 350 mg Evolocumab 420 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/55 (0.00%)   2/56 (3.57%) 
Cardiac disorders       
Atrial fibrillation  1  0/56 (0.00%)  0/55 (0.00%)  1/56 (1.79%) 
Infections and infestations       
Appendicitis  1  0/56 (0.00%)  0/55 (0.00%)  1/56 (1.79%) 
Postoperative wound infection  1  0/56 (0.00%)  0/55 (0.00%)  1/56 (1.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Evolocumab 350 mg Evolocumab 420 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/56 (42.86%)   22/55 (40.00%)   19/56 (33.93%) 
Gastrointestinal disorders       
Diarrhoea  1  3/56 (5.36%)  0/55 (0.00%)  2/56 (3.57%) 
Nausea  1  3/56 (5.36%)  1/55 (1.82%)  1/56 (1.79%) 
General disorders       
Injection site pain  1  1/56 (1.79%)  5/55 (9.09%)  2/56 (3.57%) 
Infections and infestations       
Influenza  1  6/56 (10.71%)  1/55 (1.82%)  4/56 (7.14%) 
Nasopharyngitis  1  6/56 (10.71%)  7/55 (12.73%)  7/56 (12.50%) 
Sinusitis  1  1/56 (1.79%)  3/55 (5.45%)  1/56 (1.79%) 
Upper respiratory tract infection  1  0/56 (0.00%)  3/55 (5.45%)  2/56 (3.57%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  3/56 (5.36%)  0/55 (0.00%)  0/56 (0.00%) 
Nervous system disorders       
Headache  1  5/56 (8.93%)  3/55 (5.45%)  3/56 (5.36%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/56 (5.36%)  1/55 (1.82%)  0/56 (0.00%) 
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 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
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01375751     History of Changes
Other Study ID Numbers: 20090158
First Submitted: June 16, 2011
First Posted: June 17, 2011
Results First Submitted: August 28, 2015
Results First Posted: September 29, 2015
Last Update Posted: November 2, 2018