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GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (GLAGOV)

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ClinicalTrials.gov Identifier: NCT01813422
Recruitment Status : Completed
First Posted : March 19, 2013
Results First Posted : January 4, 2018
Last Update Posted : February 20, 2019
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
Interventions Biological: Evolocumab
Drug: Placebo
Enrollment 970
Recruitment Details This study was conducted at 163 centers in 30 countries in Europe, North America, Asia Pacific, and Latin America. The first participant was enrolled on 18 April 2013 and the last participant enrolled on 12 January 2015.
Pre-assignment Details Participants who met all entry criteria were randomized 1:1 to receive evolocumab 420 mg once monthly (QM) subcutaneous (SC) or placebo QM SC for 76 weeks. Randomization was stratified by region.
Arm/Group Title Placebo Evolocumab
Hide Arm/Group Description Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks. Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
Period Title: Overall Study
Started 486 484
Received Treatment 484 484
Completed 466 468
Not Completed 20 16
Reason Not Completed
Withdrawal by Subject             14             8
Death             2             3
Sponsor Decision             2             1
Lost to Follow-up             2             4
Arm/Group Title Placebo Evolocumab Total
Hide Arm/Group Description Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks. Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks. Total of all reporting groups
Overall Number of Baseline Participants 486 484 970
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 486 participants 484 participants 970 participants
59.8  (8.8) 59.8  (9.6) 59.8  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 486 participants 484 participants 970 participants
Female
135
  27.8%
135
  27.9%
270
  27.8%
Male
351
  72.2%
349
  72.1%
700
  72.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 486 participants 484 participants 970 participants
Hispanic or Latino
24
   4.9%
34
   7.0%
58
   6.0%
Not Hispanic or Latino
462
  95.1%
450
  93.0%
912
  94.0%
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 486 participants 484 participants 970 participants
American Indian or Alaska Native 2 0 2
Asian 17 14 31
Native Hawaiian or Other Pacific Islander 0 1 1
Black or African American 5 4 9
White 453 456 909
Multiple 6 7 13
Other 3 2 5
Stratification Factor: Geographical Region  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 486 participants 484 participants 970 participants
North America 88 86 174
Europe 332 332 664
Latin America 16 15 31
Asia Pacific 50 51 101
1.Primary Outcome
Title Change From Baseline in Percent Atheroma Volume at Week 78
Hide Description Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.
Time Frame Baseline and week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)
Arm/Group Title Placebo Evolocumab
Hide Arm/Group Description:
Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
Overall Number of Participants Analyzed 423 423
Least Squares Mean (Standard Error)
Unit of Measure: percent atheroma volume
0.053  (0.189) -0.955  (0.190)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline PAV.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -1.007
Confidence Interval (2-Sided) 95%
-1.375 to -0.640
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.187
Estimation Comments Treatment difference uses placebo as the reference.
2.Secondary Outcome
Title Change From Baseline in Total Atheroma Volume at Week 78
Hide Description Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.
Time Frame Baseline and week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)
Arm/Group Title Placebo Evolocumab
Hide Arm/Group Description:
Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
Overall Number of Participants Analyzed 423 423
Least Squares Mean (Standard Error)
Unit of Measure: mm³
-0.910  (1.214) -5.799  (1.216)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline TAV.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -4.889
Confidence Interval (2-Sided) 95%
-7.247 to -2.531
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.201
Estimation Comments Treatment difference uses placebo as the reference.
3.Secondary Outcome
Title Percentage of Participants With Regression in Percent Atheroma Volume
Hide Description

Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.

Regression in PAV was defined as any reduction from baseline in PAV.

Time Frame Baseline and week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)
Arm/Group Title Placebo Evolocumab
Hide Arm/Group Description:
Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
Overall Number of Participants Analyzed 423 423
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
47.3
(42.6 to 52.0)
64.3
(59.6 to 68.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Based on CMH test stratified by geographic region.
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 17.0
Confidence Interval (2-Sided) 95%
10.3 to 23.5
Estimation Comments Treatment difference uses placebo as the reference.
4.Secondary Outcome
Title Percentage of Participants With Regression in Total Atheroma Volume
Hide Description

Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.

Regression in TAV was defined as any reduction from baseline in TAV.

Time Frame Baseline and week 78
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)
Arm/Group Title Placebo Evolocumab
Hide Arm/Group Description:
Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks.
Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
Overall Number of Participants Analyzed 423 423
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48.9
(44.2 to 53.7)
61.5
(56.7 to 66.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Based on CMH test stratified by geographic region.
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 12.5
Confidence Interval (2-Sided) 95%
5.8 to 19.1
Estimation Comments Treatment difference uses placebo as the reference.
Time Frame From first dose of study drug until week 80
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
Hide Arm/Group Description Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks. Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks.
All-Cause Mortality
Placebo Evolocumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Evolocumab
Affected / at Risk (%) Affected / at Risk (%)
Total   142/484 (29.34%)   135/484 (27.89%) 
Blood and lymphatic system disorders     
Anaemia  1  1/484 (0.21%)  2/484 (0.41%) 
Cardiac disorders     
Acute coronary syndrome  1  3/484 (0.62%)  1/484 (0.21%) 
Acute myocardial infarction  1  5/484 (1.03%)  6/484 (1.24%) 
Angina pectoris  1  11/484 (2.27%)  17/484 (3.51%) 
Angina unstable  1  7/484 (1.45%)  8/484 (1.65%) 
Aortic valve stenosis  1  1/484 (0.21%)  1/484 (0.21%) 
Arteriosclerosis coronary artery  1  5/484 (1.03%)  0/484 (0.00%) 
Atrial fibrillation  1  4/484 (0.83%)  6/484 (1.24%) 
Atrial flutter  1  0/484 (0.00%)  1/484 (0.21%) 
Atrioventricular block  1  0/484 (0.00%)  1/484 (0.21%) 
Atrioventricular block complete  1  1/484 (0.21%)  0/484 (0.00%) 
Atrioventricular block second degree  1  0/484 (0.00%)  1/484 (0.21%) 
Bradycardia  1  0/484 (0.00%)  1/484 (0.21%) 
Cardiac disorder  1  0/484 (0.00%)  1/484 (0.21%) 
Cardiac failure  1  2/484 (0.41%)  0/484 (0.00%) 
Cardiac failure chronic  1  1/484 (0.21%)  0/484 (0.00%) 
Cardiac failure congestive  1  0/484 (0.00%)  1/484 (0.21%) 
Cardiac tamponade  1  0/484 (0.00%)  1/484 (0.21%) 
Coronary artery disease  1  13/484 (2.69%)  7/484 (1.45%) 
Coronary artery dissection  1  2/484 (0.41%)  1/484 (0.21%) 
Coronary artery occlusion  1  1/484 (0.21%)  3/484 (0.62%) 
Coronary artery stenosis  1  5/484 (1.03%)  3/484 (0.62%) 
Left ventricular dysfunction  1  1/484 (0.21%)  0/484 (0.00%) 
Mitral valve incompetence  1  2/484 (0.41%)  0/484 (0.00%) 
Myocardial infarction  1  4/484 (0.83%)  0/484 (0.00%) 
Myocardial ischaemia  1  3/484 (0.62%)  1/484 (0.21%) 
Palpitations  1  2/484 (0.41%)  0/484 (0.00%) 
Pericarditis  1  0/484 (0.00%)  1/484 (0.21%) 
Sinoatrial block  1  0/484 (0.00%)  1/484 (0.21%) 
Supraventricular tachycardia  1  2/484 (0.41%)  0/484 (0.00%) 
Ventricular arrhythmia  1  0/484 (0.00%)  1/484 (0.21%) 
Ventricular fibrillation  1  1/484 (0.21%)  0/484 (0.00%) 
Ventricular tachycardia  1  2/484 (0.41%)  0/484 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/484 (0.21%)  0/484 (0.00%) 
Eye disorders     
Amaurosis fugax  1  1/484 (0.21%)  0/484 (0.00%) 
Cataract  1  0/484 (0.00%)  1/484 (0.21%) 
Diabetic retinopathy  1  1/484 (0.21%)  0/484 (0.00%) 
Retinopathy  1  1/484 (0.21%)  0/484 (0.00%) 
Gastrointestinal disorders     
Diverticular perforation  1  1/484 (0.21%)  0/484 (0.00%) 
Dysphagia  1  1/484 (0.21%)  0/484 (0.00%) 
Erosive duodenitis  1  0/484 (0.00%)  1/484 (0.21%) 
Gastric ulcer  1  0/484 (0.00%)  1/484 (0.21%) 
Gastric ulcer haemorrhage  1  0/484 (0.00%)  1/484 (0.21%) 
Gastritis  1  0/484 (0.00%)  2/484 (0.41%) 
Ileal perforation  1  1/484 (0.21%)  0/484 (0.00%) 
Inguinal hernia  1  2/484 (0.41%)  0/484 (0.00%) 
Large intestine polyp  1  0/484 (0.00%)  1/484 (0.21%) 
Lower gastrointestinal haemorrhage  1  0/484 (0.00%)  1/484 (0.21%) 
Nausea  1  0/484 (0.00%)  1/484 (0.21%) 
Oesophagitis  1  0/484 (0.00%)  1/484 (0.21%) 
Pancreatitis acute  1  0/484 (0.00%)  1/484 (0.21%) 
Small intestinal obstruction  1  1/484 (0.21%)  0/484 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/484 (0.00%)  1/484 (0.21%) 
Vomiting  1  1/484 (0.21%)  1/484 (0.21%) 
General disorders     
Chest discomfort  1  1/484 (0.21%)  1/484 (0.21%) 
Chest pain  1  0/484 (0.00%)  1/484 (0.21%) 
Malaise  1  0/484 (0.00%)  1/484 (0.21%) 
Non-cardiac chest pain  1  6/484 (1.24%)  11/484 (2.27%) 
Oedema peripheral  1  0/484 (0.00%)  1/484 (0.21%) 
Puncture site haemorrhage  1  0/484 (0.00%)  1/484 (0.21%) 
Sudden death  1  1/484 (0.21%)  1/484 (0.21%) 
Systemic inflammatory response syndrome  1  0/484 (0.00%)  1/484 (0.21%) 
Vascular stent restenosis  1  2/484 (0.41%)  3/484 (0.62%) 
Vascular stent stenosis  1  0/484 (0.00%)  1/484 (0.21%) 
Vessel puncture site haemorrhage  1  0/484 (0.00%)  1/484 (0.21%) 
Hepatobiliary disorders     
Cholecystitis acute  1  2/484 (0.41%)  0/484 (0.00%) 
Cholelithiasis  1  1/484 (0.21%)  0/484 (0.00%) 
Gallbladder enlargement  1  1/484 (0.21%)  0/484 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  0/484 (0.00%)  1/484 (0.21%) 
Infections and infestations     
Abdominal abscess  1  1/484 (0.21%)  0/484 (0.00%) 
Appendicitis  1  1/484 (0.21%)  1/484 (0.21%) 
Brain abscess  1  0/484 (0.00%)  1/484 (0.21%) 
Bronchitis  1  0/484 (0.00%)  2/484 (0.41%) 
Bursitis infective staphylococcal  1  1/484 (0.21%)  0/484 (0.00%) 
Clostridium difficile colitis  1  0/484 (0.00%)  1/484 (0.21%) 
Diverticulitis  1  1/484 (0.21%)  1/484 (0.21%) 
Eye infection toxoplasmal  1  1/484 (0.21%)  0/484 (0.00%) 
Gastroenteritis  1  1/484 (0.21%)  1/484 (0.21%) 
Gastroenteritis viral  1  1/484 (0.21%)  0/484 (0.00%) 
Kidney infection  1  0/484 (0.00%)  1/484 (0.21%) 
Pneumonia  1  5/484 (1.03%)  0/484 (0.00%) 
Postoperative wound infection  1  1/484 (0.21%)  0/484 (0.00%) 
Pyelonephritis acute  1  1/484 (0.21%)  0/484 (0.00%) 
Pyonephrosis  1  0/484 (0.00%)  1/484 (0.21%) 
Sepsis  1  0/484 (0.00%)  1/484 (0.21%) 
Sinusitis  1  0/484 (0.00%)  1/484 (0.21%) 
Staphylococcal sepsis  1  1/484 (0.21%)  0/484 (0.00%) 
Urinary tract infection  1  0/484 (0.00%)  2/484 (0.41%) 
Vestibular neuronitis  1  1/484 (0.21%)  1/484 (0.21%) 
Injury, poisoning and procedural complications     
Cervical vertebral fracture  1  1/484 (0.21%)  0/484 (0.00%) 
Contusion  1  0/484 (0.00%)  1/484 (0.21%) 
Fall  1  0/484 (0.00%)  2/484 (0.41%) 
Head injury  1  0/484 (0.00%)  2/484 (0.41%) 
Humerus fracture  1  0/484 (0.00%)  1/484 (0.21%) 
Joint dislocation  1  1/484 (0.21%)  0/484 (0.00%) 
Laceration  1  0/484 (0.00%)  1/484 (0.21%) 
Limb traumatic amputation  1  0/484 (0.00%)  1/484 (0.21%) 
Lumbar vertebral fracture  1  1/484 (0.21%)  0/484 (0.00%) 
Post procedural haematoma  1  0/484 (0.00%)  1/484 (0.21%) 
Post procedural haemorrhage  1  1/484 (0.21%)  1/484 (0.21%) 
Procedural dizziness  1  0/484 (0.00%)  1/484 (0.21%) 
Road traffic accident  1  1/484 (0.21%)  0/484 (0.00%) 
Skeletal injury  1  0/484 (0.00%)  1/484 (0.21%) 
Subdural haematoma  1  1/484 (0.21%)  1/484 (0.21%) 
Vascular pseudoaneurysm  1  0/484 (0.00%)  1/484 (0.21%) 
Investigations     
Alanine aminotransferase increased  1  1/484 (0.21%)  2/484 (0.41%) 
Arteriogram coronary  1  0/484 (0.00%)  1/484 (0.21%) 
Blood creatinine increased  1  2/484 (0.41%)  0/484 (0.00%) 
Blood pressure increased  1  0/484 (0.00%)  1/484 (0.21%) 
Liver function test increased  1  1/484 (0.21%)  0/484 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  2/484 (0.41%)  2/484 (0.41%) 
Hypokalaemia  1  0/484 (0.00%)  1/484 (0.21%) 
Obesity  1  1/484 (0.21%)  0/484 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/484 (0.00%)  1/484 (0.21%) 
Back pain  1  3/484 (0.62%)  0/484 (0.00%) 
Bursitis  1  1/484 (0.21%)  0/484 (0.00%) 
Costochondritis  1  0/484 (0.00%)  1/484 (0.21%) 
Intervertebral disc degeneration  1  1/484 (0.21%)  1/484 (0.21%) 
Intervertebral disc protrusion  1  1/484 (0.21%)  2/484 (0.41%) 
Joint effusion  1  1/484 (0.21%)  0/484 (0.00%) 
Musculoskeletal chest pain  1  1/484 (0.21%)  0/484 (0.00%) 
Musculoskeletal pain  1  0/484 (0.00%)  1/484 (0.21%) 
Myalgia  1  1/484 (0.21%)  2/484 (0.41%) 
Osteoarthritis  1  4/484 (0.83%)  1/484 (0.21%) 
Osteochondrosis  1  0/484 (0.00%)  1/484 (0.21%) 
Osteoporosis  1  0/484 (0.00%)  1/484 (0.21%) 
Rheumatoid arthritis  1  1/484 (0.21%)  0/484 (0.00%) 
Spinal column stenosis  1  0/484 (0.00%)  1/484 (0.21%) 
Spinal osteoarthritis  1  1/484 (0.21%)  1/484 (0.21%) 
Spinal pain  1  1/484 (0.21%)  0/484 (0.00%) 
Spondylitis  1  1/484 (0.21%)  0/484 (0.00%) 
Spondylolisthesis  1  0/484 (0.00%)  1/484 (0.21%) 
Vertebral foraminal stenosis  1  1/484 (0.21%)  0/484 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acoustic neuroma  1  0/484 (0.00%)  1/484 (0.21%) 
Adenocarcinoma of colon  1  0/484 (0.00%)  1/484 (0.21%) 
Basosquamous carcinoma of skin  1  1/484 (0.21%)  0/484 (0.00%) 
Benign pancreatic neoplasm  1  0/484 (0.00%)  1/484 (0.21%) 
Bladder cancer  1  1/484 (0.21%)  0/484 (0.00%) 
Bladder cancer stage I, with cancer in situ  1  1/484 (0.21%)  0/484 (0.00%) 
Breast cancer  1  2/484 (0.41%)  0/484 (0.00%) 
Cervix carcinoma stage 0  1  0/484 (0.00%)  1/484 (0.21%) 
Chemodectoma  1  1/484 (0.21%)  0/484 (0.00%) 
Endometrial adenocarcinoma  1  0/484 (0.00%)  1/484 (0.21%) 
Gastrointestinal tract adenoma  1  1/484 (0.21%)  0/484 (0.00%) 
Hepatic neoplasm  1  0/484 (0.00%)  1/484 (0.21%) 
Lung adenocarcinoma  1  1/484 (0.21%)  1/484 (0.21%) 
Lung adenocarcinoma metastatic  1  1/484 (0.21%)  0/484 (0.00%) 
Lung carcinoma cell type unspecified stage III  1  0/484 (0.00%)  1/484 (0.21%) 
Lung neoplasm malignant  1  0/484 (0.00%)  1/484 (0.21%) 
Malignant melanoma  1  1/484 (0.21%)  0/484 (0.00%) 
Prostate cancer  1  2/484 (0.41%)  0/484 (0.00%) 
Rectal adenocarcinoma  1  1/484 (0.21%)  0/484 (0.00%) 
Rectal cancer  1  0/484 (0.00%)  1/484 (0.21%) 
Renal cancer  1  0/484 (0.00%)  1/484 (0.21%) 
Renal cell carcinoma  1  0/484 (0.00%)  1/484 (0.21%) 
Skin cancer  1  1/484 (0.21%)  0/484 (0.00%) 
Transitional cell carcinoma  1  0/484 (0.00%)  1/484 (0.21%) 
Ureteral neoplasm  1  1/484 (0.21%)  0/484 (0.00%) 
Uterine leiomyoma  1  1/484 (0.21%)  0/484 (0.00%) 
Nervous system disorders     
Carotid artery stenosis  1  0/484 (0.00%)  1/484 (0.21%) 
Cerebral ischaemia  1  0/484 (0.00%)  1/484 (0.21%) 
Cerebrovascular accident  1  2/484 (0.41%)  0/484 (0.00%) 
Epilepsy  1  0/484 (0.00%)  1/484 (0.21%) 
Facial paresis  1  0/484 (0.00%)  1/484 (0.21%) 
Intracranial aneurysm  1  1/484 (0.21%)  0/484 (0.00%) 
Loss of consciousness  1  0/484 (0.00%)  1/484 (0.21%) 
Sciatica  1  0/484 (0.00%)  1/484 (0.21%) 
Sensory disturbance  1  0/484 (0.00%)  1/484 (0.21%) 
Syncope  1  1/484 (0.21%)  3/484 (0.62%) 
Transient ischaemic attack  1  1/484 (0.21%)  1/484 (0.21%) 
Tremor  1  0/484 (0.00%)  1/484 (0.21%) 
Product Issues     
Device leakage  1  1/484 (0.21%)  0/484 (0.00%) 
Psychiatric disorders     
Anxiety disorder  1  0/484 (0.00%)  1/484 (0.21%) 
Depression  1  1/484 (0.21%)  3/484 (0.62%) 
Mental status changes  1  1/484 (0.21%)  0/484 (0.00%) 
Paranoia  1  0/484 (0.00%)  1/484 (0.21%) 
Renal and urinary disorders     
Acute kidney injury  1  1/484 (0.21%)  0/484 (0.00%) 
Bladder prolapse  1  0/484 (0.00%)  1/484 (0.21%) 
Chronic kidney disease  1  1/484 (0.21%)  0/484 (0.00%) 
Nephrolithiasis  1  0/484 (0.00%)  3/484 (0.62%) 
Renal artery stenosis  1  1/484 (0.21%)  0/484 (0.00%) 
Renal colic  1  0/484 (0.00%)  1/484 (0.21%) 
Stress urinary incontinence  1  1/484 (0.21%)  0/484 (0.00%) 
Ureteric obstruction  1  0/484 (0.00%)  1/484 (0.21%) 
Urinary retention  1  2/484 (0.41%)  0/484 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/484 (0.00%)  2/484 (0.41%) 
Cervical polyp  1  0/484 (0.00%)  1/484 (0.21%) 
Uterine haemorrhage  1  1/484 (0.21%)  0/484 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/484 (0.21%)  1/484 (0.21%) 
Chronic obstructive pulmonary disease  1  1/484 (0.21%)  4/484 (0.83%) 
Dyspnoea  1  1/484 (0.21%)  0/484 (0.00%) 
Dyspnoea exertional  1  1/484 (0.21%)  0/484 (0.00%) 
Epistaxis  1  1/484 (0.21%)  0/484 (0.00%) 
Pneumonia aspiration  1  1/484 (0.21%)  0/484 (0.00%) 
Pulmonary embolism  1  1/484 (0.21%)  2/484 (0.41%) 
Pulmonary hypertension  1  0/484 (0.00%)  1/484 (0.21%) 
Respiratory failure  1  0/484 (0.00%)  1/484 (0.21%) 
Sleep apnoea syndrome  1  0/484 (0.00%)  1/484 (0.21%) 
Skin and subcutaneous tissue disorders     
Skin ulcer  1  0/484 (0.00%)  1/484 (0.21%) 
Surgical and medical procedures     
Coronary arterial stent insertion  1  1/484 (0.21%)  0/484 (0.00%) 
Coronary revascularisation  1  1/484 (0.21%)  1/484 (0.21%) 
Hip arthroplasty  1  0/484 (0.00%)  1/484 (0.21%) 
Mammoplasty  1  0/484 (0.00%)  1/484 (0.21%) 
Vascular disorders     
Aortic aneurysm  1  0/484 (0.00%)  2/484 (0.41%) 
Arteriosclerosis  1  2/484 (0.41%)  0/484 (0.00%) 
Hypertension  1  4/484 (0.83%)  0/484 (0.00%) 
Hypotension  1  0/484 (0.00%)  3/484 (0.62%) 
Peripheral arterial occlusive disease  1  2/484 (0.41%)  1/484 (0.21%) 
Peripheral artery thrombosis  1  0/484 (0.00%)  1/484 (0.21%) 
Peripheral vascular disorder  1  0/484 (0.00%)  1/484 (0.21%) 
Raynaud's phenomenon  1  1/484 (0.21%)  0/484 (0.00%) 
Vasoconstriction  1  0/484 (0.00%)  1/484 (0.21%) 
Vessel perforation  1  0/484 (0.00%)  1/484 (0.21%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Evolocumab
Affected / at Risk (%) Affected / at Risk (%)
Total   120/484 (24.79%)   114/484 (23.55%) 
Cardiac disorders     
Angina pectoris  1  32/484 (6.61%)  21/484 (4.34%) 
General disorders     
Chest pain  1  26/484 (5.37%)  33/484 (6.82%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  27/484 (5.58%)  34/484 (7.02%) 
Nervous system disorders     
Headache  1  29/484 (5.99%)  19/484 (3.93%) 
Vascular disorders     
Hypertension  1  34/484 (7.02%)  29/484 (5.99%) 
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: NCT01813422     History of Changes
Other Study ID Numbers: 20120153
2012-004208-37 ( EudraCT Number )
First Submitted: March 15, 2013
First Posted: March 19, 2013
Results First Submitted: December 4, 2017
Results First Posted: January 4, 2018
Last Update Posted: February 20, 2019