Trial Outcomes & Findings for Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067) (NCT NCT00479388)
NCT ID: NCT00479388
Last Updated: 2015-03-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1216 participants
Primary outcome timeframe
Baseline and 12 Weeks
Results posted on
2015-03-10
Participant Flow
First Patient In: 30-Jul-2007 Last Patient Last Visit: 10-Jul-2008 Investigators: 161 sites participated: Australia-5; Austria-4; Canada-11; Czech Republic-5; Denmark-4; France-10; Germany-24; Hungary-6; Israel-4; Italy-11; Netherlands-2; Norway-10; Poland-11; Russian Federation-7; South Africa-9; Spain-4; Sweden-17; United States-17
Patients on atorvastatin (10mg) or simvastatin (10mg or 20mg) had a 2 week run-in of their statin. Naïve patients or patients on other statins were started on simvastatin (10 or 20mg) or atorvastatin (10mg) for a 6 week run-in. Patients were eligible to be randomized if their Visit 1 low density lipoprotein cholesterol values were above goal.
Participant milestones
| Measure |
ER Niacin/Laropiprant + Run-in Statin
One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
|
Run-in Statin Dose Doubled
Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
606
|
610
|
|
Overall Study
COMPLETED
|
474
|
537
|
|
Overall Study
NOT COMPLETED
|
132
|
73
|
Reasons for withdrawal
| Measure |
ER Niacin/Laropiprant + Run-in Statin
One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
|
Run-in Statin Dose Doubled
Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
90
|
45
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Protocol Violation
|
10
|
9
|
|
Overall Study
Withdrawal by Subject
|
32
|
17
|
Baseline Characteristics
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
Baseline characteristics by cohort
| Measure |
ER Niacin/Laropiprant + Run-in Statin
n=606 Participants
One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
|
Run-in Statin Dose Doubled
n=610 Participants
Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
|
Total
n=1216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
304 Participants
n=5 Participants
|
289 Participants
n=7 Participants
|
593 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
302 Participants
n=5 Participants
|
321 Participants
n=7 Participants
|
623 Participants
n=5 Participants
|
|
Coronary Heart Disease Risk Category by Goal
Low Risk at Goal
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Coronary Heart Disease Risk Category by Goal
Low Risk Not at Goal
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Coronary Heart Disease Risk Category by Goal
Multiple Risk at Goal
|
91 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Coronary Heart Disease Risk Category by Goal
Multiple Risk Not at Goal
|
92 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Coronary Heart Disease Risk Category by Goal
High Risk at Goal
|
143 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
298 Participants
n=5 Participants
|
|
Coronary Heart Disease Risk Category by Goal
High Risk Not at Goal
|
237 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
499 Participants
n=5 Participants
|
|
Lipid Modification Type/Dose at Run-in
Simvastatin 10 mg
|
218 participants
n=5 Participants
|
233 participants
n=7 Participants
|
451 participants
n=5 Participants
|
|
Lipid Modification Type/Dose at Run-in
Simvastatin 20 mg
|
259 participants
n=5 Participants
|
268 participants
n=7 Participants
|
527 participants
n=5 Participants
|
|
Lipid Modification Type/Dose at Run-in
Atorvastatin 10 mg
|
129 participants
n=5 Participants
|
109 participants
n=7 Participants
|
238 participants
n=5 Participants
|
|
Fasting Serum Glucose (FSG)
|
108.3 mg/dL
STANDARD_DEVIATION 27.2 • n=5 Participants
|
108.7 mg/dL
STANDARD_DEVIATION 27.7 • n=7 Participants
|
108.5 mg/dL
STANDARD_DEVIATION 27.4 • n=5 Participants
|
|
High-density lipoprotein cholesterol
|
54.89 mg/dL
STANDARD_DEVIATION 14.45 • n=5 Participants
|
54.97 mg/dL
STANDARD_DEVIATION 13.91 • n=7 Participants
|
54.93 mg/dL
STANDARD_DEVIATION 14.17 • n=5 Participants
|
|
Low-density lipoprotein cholesterol
|
117.55 mg/dL
STANDARD_DEVIATION 28.66 • n=5 Participants
|
115.82 mg/dL
STANDARD_DEVIATION 28.37 • n=7 Participants
|
116.68 mg/dL
STANDARD_DEVIATION 28.52 • n=5 Participants
|
|
Triglycerides (TG)
|
136.00 mg/dL
n=5 Participants
|
124.00 mg/dL
n=7 Participants
|
130.00 mg/dL
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Full Analysis Set
Outcome measures
| Measure |
ER Niacin/Laropiprant + Run-in Statin
n=572 Participants
One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
|
Run-in Statin Dose Doubled
n=595 Participants
Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12
|
-10.0 Percent
Interval -12.6 to -7.4
|
-5.5 Percent
Interval -7.4 to -3.5
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Full Analysis Set
Outcome measures
| Measure |
ER Niacin/Laropiprant + Run-in Statin
n=572 Participants
One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
|
Run-in Statin Dose Doubled
n=595 Participants
Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12
|
15.8 Percent
Interval 13.8 to 17.8
|
0.2 Percent
Interval -1.1 to 1.4
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Full Analysis Set With at Least one Post-Titration Visit Measurement
Outcome measures
| Measure |
ER Niacin/Laropiprant + Run-in Statin
n=515 Participants
One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
|
Run-in Statin Dose Doubled
n=571 Participants
Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Triglycerides at Week 12
|
-17.6 Percent
Interval -21.0 to -14.2
|
-4.0 Percent
Interval -7.2 to -0.9
|
Adverse Events
ER Niacin/Laropiprant + Run-in Statin
Serious events: 14 serious events
Other events: 249 other events
Deaths: 0 deaths
Run-in Statin Dose Doubled
Serious events: 8 serious events
Other events: 172 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ER Niacin/Laropiprant + Run-in Statin
One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
|
Run-in Statin Dose Doubled
Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.17%
1/602
|
0.00%
0/609
|
|
Cardiac disorders
Acute myocardial infarction
|
0.17%
1/602
|
0.00%
0/609
|
|
Cardiac disorders
Cardiac failure congestive
|
0.17%
1/602
|
0.00%
0/609
|
|
Eye disorders
Eye discharge
|
0.17%
1/602
|
0.00%
0/609
|
|
General disorders
Chest pain
|
0.00%
0/602
|
0.16%
1/609
|
|
General disorders
Non-cardiac chest pain
|
0.17%
1/602
|
0.00%
0/609
|
|
Immune system disorders
Drug hypersensitivity
|
0.17%
1/602
|
0.00%
0/609
|
|
Infections and infestations
Acute sinusitis
|
0.17%
1/602
|
0.00%
0/609
|
|
Immune system disorders
Oral herpes
|
0.17%
1/602
|
0.00%
0/609
|
|
Infections and infestations
Wound sepsis
|
0.17%
1/602
|
0.00%
0/609
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/602
|
0.16%
1/609
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.17%
1/602
|
0.00%
0/609
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/602
|
0.16%
1/609
|
|
Nervous system disorders
Amnesia
|
0.00%
0/602
|
0.16%
1/609
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/602
|
0.16%
1/609
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/602
|
0.16%
1/609
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.17%
1/602
|
0.00%
0/609
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/602
|
0.16%
1/609
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/602
|
0.16%
1/609
|
|
Vascular disorders
Flushing
|
0.17%
1/602
|
0.00%
0/609
|
|
Vascular disorders
Hypotension
|
0.17%
1/602
|
0.00%
0/609
|
|
Vascular disorders
Peripheral ischaemia
|
0.17%
1/602
|
0.00%
0/609
|
Other adverse events
| Measure |
ER Niacin/Laropiprant + Run-in Statin
One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
|
Run-in Statin Dose Doubled
Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
|
|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/602
|
0.16%
1/609
|
|
Eye disorders
Conjunctivitis
|
0.17%
1/602
|
0.66%
4/609
|
|
Eye disorders
Dry eye
|
0.17%
1/602
|
0.00%
0/609
|
|
Eye disorders
Eye inflammation
|
0.17%
1/602
|
0.00%
0/609
|
|
Eye disorders
Eye irritation
|
0.17%
1/602
|
0.00%
0/609
|
|
Eye disorders
Eyelid oedema
|
0.17%
1/602
|
0.00%
0/609
|
|
Eye disorders
Lacrimation increased
|
0.17%
1/602
|
0.00%
0/609
|
|
Eye disorders
Retinal artery thrombosis
|
0.00%
0/602
|
0.16%
1/609
|
|
Eye disorders
Vision blurred
|
0.00%
0/602
|
0.16%
1/609
|
|
Eye disorders
Visual disturbance
|
0.17%
1/602
|
0.00%
0/609
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/602
|
0.16%
1/609
|
|
Gastrointestinal disorders
Abdominal pain
|
1.00%
6/602
|
0.66%
4/609
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.17%
1/602
|
0.00%
0/609
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
12/602
|
0.66%
4/609
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/602
|
0.33%
2/609
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/602
|
0.16%
1/609
|
|
Gastrointestinal disorders
Constipation
|
0.17%
1/602
|
0.99%
6/609
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
16/602
|
0.66%
4/609
|
|
Gastrointestinal disorders
Dry mouth
|
1.00%
6/602
|
0.00%
0/609
|
|
Gastrointestinal disorders
Duodenitis
|
0.33%
2/602
|
0.00%
0/609
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
7/602
|
0.82%
5/609
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/602
|
0.49%
3/609
|
|
Gastrointestinal disorders
Eructation
|
0.17%
1/602
|
0.00%
0/609
|
|
Gastrointestinal disorders
Flatulence
|
0.17%
1/602
|
0.49%
3/609
|
|
Gastrointestinal disorders
Gastritis
|
0.33%
2/602
|
0.16%
1/609
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.17%
1/602
|
0.00%
0/609
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/602
|
0.33%
2/609
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.17%
1/602
|
0.00%
0/609
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/602
|
0.16%
1/609
|
|
Gastrointestinal disorders
Nausea
|
3.3%
20/602
|
1.5%
9/609
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/602
|
0.16%
1/609
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.17%
1/602
|
0.00%
0/609
|
|
Gastrointestinal disorders
Stomatitis
|
0.17%
1/602
|
0.00%
0/609
|
|
Gastrointestinal disorders
Toothache
|
0.33%
2/602
|
0.00%
0/609
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
7/602
|
0.66%
4/609
|
|
General disorders
Asthenia
|
0.33%
2/602
|
0.16%
1/609
|
|
General disorders
Chest discomfort
|
0.00%
0/602
|
0.16%
1/609
|
|
General disorders
Chest pain
|
0.17%
1/602
|
0.16%
1/609
|
|
General disorders
Chills
|
0.17%
1/602
|
0.16%
1/609
|
|
General disorders
Discomfort
|
0.33%
2/602
|
0.00%
0/609
|
|
General disorders
Fatigue
|
0.17%
1/602
|
0.33%
2/609
|
|
General disorders
Feeling cold
|
0.00%
0/602
|
0.16%
1/609
|
|
General disorders
Feeling hot
|
1.5%
9/602
|
0.49%
3/609
|
|
General disorders
Influenza like illness
|
0.00%
0/602
|
0.16%
1/609
|
|
General disorders
Malaise
|
0.17%
1/602
|
0.33%
2/609
|
|
General disorders
Non-cardiac chest pain
|
0.17%
1/602
|
0.16%
1/609
|
|
General disorders
Oedema peripheral
|
0.33%
2/602
|
0.49%
3/609
|
|
General disorders
Pain
|
0.33%
2/602
|
0.00%
0/609
|
|
General disorders
Pyrexia
|
0.33%
2/602
|
0.00%
0/609
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/602
|
0.16%
1/609
|
|
Immune system disorders
Drug hypersensitivity
|
0.17%
1/602
|
0.00%
0/609
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/602
|
0.33%
2/609
|
|
Infections and infestations
Balanitis candida
|
0.17%
1/602
|
0.00%
0/609
|
|
Infections and infestations
Breast abscess
|
0.00%
0/602
|
0.16%
1/609
|
|
Infections and infestations
Bronchitis
|
1.8%
11/602
|
0.82%
5/609
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/602
|
0.16%
1/609
|
|
Infections and infestations
Bronchopneumonia
|
0.17%
1/602
|
0.16%
1/609
|
|
Infections and infestations
Candidiasis
|
0.00%
0/602
|
0.16%
1/609
|
|
Infections and infestations
Cystitis
|
0.33%
2/602
|
0.33%
2/609
|
|
Infections and infestations
Ear infection
|
0.00%
0/602
|
0.16%
1/609
|
|
Infections and infestations
Furuncle
|
0.17%
1/602
|
0.00%
0/609
|
|
Infections and infestations
Gastroenteritis
|
0.50%
3/602
|
0.99%
6/609
|
|
Infections and infestations
Herpes simplex
|
0.17%
1/602
|
0.00%
0/609
|
|
Infections and infestations
Herpes zoster
|
0.33%
2/602
|
0.16%
1/609
|
|
Infections and infestations
Influenza
|
0.66%
4/602
|
0.49%
3/609
|
|
Infections and infestations
Mycoplasma infection
|
0.00%
0/602
|
0.16%
1/609
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
13/602
|
2.5%
15/609
|
|
Infections and infestations
Oral herpes
|
0.17%
1/602
|
0.00%
0/609
|
|
Infections and infestations
Otitis media
|
0.33%
2/602
|
0.00%
0/609
|
|
Infections and infestations
Pharyngitis
|
0.17%
1/602
|
0.00%
0/609
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/602
|
0.16%
1/609
|
|
Infections and infestations
Respiratory tract infection
|
0.33%
2/602
|
0.33%
2/609
|
|
Infections and infestations
Rhinitis
|
0.17%
1/602
|
0.00%
0/609
|
|
Infections and infestations
Sinusitis
|
0.00%
0/602
|
0.33%
2/609
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/602
|
0.16%
1/609
|
|
Infections and infestations
Tooth infection
|
0.00%
0/602
|
0.16%
1/609
|
|
Infections and infestations
Tracheobronchitis
|
0.17%
1/602
|
0.33%
2/609
|
|
Infections and infestations
Upper respiratory tract infection
|
0.83%
5/602
|
0.99%
6/609
|
|
Infections and infestations
Urinary tract infection
|
0.33%
2/602
|
0.49%
3/609
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.17%
1/602
|
0.00%
0/609
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/602
|
0.16%
1/609
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/602
|
0.16%
1/609
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.17%
1/602
|
0.00%
0/609
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.17%
1/602
|
0.00%
0/609
|
|
Investigations
Blood pressure increased
|
0.17%
1/602
|
0.33%
2/609
|
|
Investigations
Gastric pH decreased
|
0.00%
0/602
|
0.16%
1/609
|
|
Investigations
Liver palpable subcostal
|
0.17%
1/602
|
0.00%
0/609
|
|
Investigations
Pulse abnormal
|
0.00%
0/602
|
0.16%
1/609
|
|
Investigations
Weight increased
|
0.00%
0/602
|
0.16%
1/609
|
|
Metabolism and nutrition disorders
Gout
|
0.17%
1/602
|
0.00%
0/609
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/602
|
0.16%
1/609
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/602
|
0.16%
1/609
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
0.00%
0/602
|
0.16%
1/609
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.66%
4/602
|
0.16%
1/609
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.33%
2/602
|
0.49%
3/609
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.50%
3/602
|
0.33%
2/609
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.17%
1/602
|
0.00%
0/609
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/602
|
0.16%
1/609
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/602
|
0.16%
1/609
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.50%
3/602
|
0.00%
0/609
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/602
|
0.16%
1/609
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.17%
1/602
|
0.00%
0/609
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.50%
3/602
|
0.00%
0/609
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.50%
3/602
|
0.00%
0/609
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.17%
1/602
|
0.00%
0/609
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.00%
6/602
|
2.0%
12/609
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.33%
2/602
|
0.00%
0/609
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/602
|
0.16%
1/609
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/602
|
0.16%
1/609
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/602
|
0.16%
1/609
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/602
|
0.16%
1/609
|
|
Nervous system disorders
Burning sensation
|
0.17%
1/602
|
0.00%
0/609
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.17%
1/602
|
0.00%
0/609
|
|
Nervous system disorders
Dizziness
|
1.5%
9/602
|
1.1%
7/609
|
|
Nervous system disorders
Headache
|
1.00%
6/602
|
1.8%
11/609
|
|
Nervous system disorders
Hypoaesthesia
|
0.33%
2/602
|
0.16%
1/609
|
|
Nervous system disorders
Lethargy
|
0.17%
1/602
|
0.16%
1/609
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/602
|
0.16%
1/609
|
|
Nervous system disorders
Paraesthesia
|
2.0%
12/602
|
0.33%
2/609
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/602
|
0.16%
1/609
|
|
Nervous system disorders
Sciatica
|
0.33%
2/602
|
0.16%
1/609
|
|
Nervous system disorders
Somnolence
|
0.00%
0/602
|
0.16%
1/609
|
|
Nervous system disorders
Syncope
|
0.17%
1/602
|
0.00%
0/609
|
|
Nervous system disorders
Tremor
|
0.00%
0/602
|
0.16%
1/609
|
|
Psychiatric disorders
Anger
|
0.17%
1/602
|
0.00%
0/609
|
|
Psychiatric disorders
Anxiety
|
0.17%
1/602
|
0.33%
2/609
|
|
Psychiatric disorders
Depression
|
0.00%
0/602
|
0.16%
1/609
|
|
Psychiatric disorders
Insomnia
|
0.50%
3/602
|
0.99%
6/609
|
|
Renal and urinary disorders
Dysuria
|
0.17%
1/602
|
0.00%
0/609
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/602
|
0.16%
1/609
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.17%
1/602
|
0.16%
1/609
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/602
|
0.16%
1/609
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/602
|
0.16%
1/609
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
1/602
|
0.00%
0/609
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.50%
3/602
|
0.33%
2/609
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.17%
1/602
|
0.00%
0/609
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.33%
2/602
|
0.16%
1/609
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.17%
1/602
|
0.00%
0/609
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/602
|
0.16%
1/609
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.17%
1/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Acrodermatitis
|
0.17%
1/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.17%
1/602
|
0.00%
0/609
|
|
Respiratory, thoracic and mediastinal disorders
Dandruff
|
0.00%
0/602
|
0.16%
1/609
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.33%
2/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.17%
1/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.17%
1/602
|
0.16%
1/609
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.17%
1/602
|
0.16%
1/609
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.00%
6/602
|
0.49%
3/609
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/602
|
0.16%
1/609
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.33%
2/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.17%
1/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/602
|
0.16%
1/609
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.17%
1/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
52/602
|
1.6%
10/609
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/602
|
0.16%
1/609
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/602
|
0.33%
2/609
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/602
|
0.16%
1/609
|
|
Cardiac disorders
Angina pectoris
|
0.17%
1/602
|
0.16%
1/609
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/602
|
0.16%
1/609
|
|
Cardiac disorders
Cardiac discomfort
|
0.17%
1/602
|
0.00%
0/609
|
|
Cardiac disorders
Palpitations
|
0.17%
1/602
|
0.33%
2/609
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.17%
1/602
|
0.00%
0/609
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/602
|
0.16%
1/609
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/602
|
0.16%
1/609
|
|
Ear and labyrinth disorders
Vertigo
|
0.17%
1/602
|
0.66%
4/609
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.33%
2/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
11/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.17%
1/602
|
0.33%
2/609
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.17%
1/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/602
|
0.16%
1/609
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/602
|
0.16%
1/609
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/602
|
0.16%
1/609
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/602
|
0.16%
1/609
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.50%
3/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.17%
1/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.17%
1/602
|
0.16%
1/609
|
|
Surgical and medical procedures
Swelling face
|
0.17%
1/602
|
0.00%
0/609
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.17%
1/602
|
0.33%
2/609
|
|
Vascular disorders
Blood pressure fluctuation
|
0.00%
0/602
|
0.16%
1/609
|
|
Vascular disorders
Flushing
|
11.3%
68/602
|
1.5%
9/609
|
|
Vascular disorders
Hypertension
|
0.00%
0/602
|
0.16%
1/609
|
|
Vascular disorders
Orthostatic hypotension
|
0.17%
1/602
|
0.00%
0/609
|
|
Vascular disorders
Phlebitis
|
0.00%
0/602
|
0.16%
1/609
|
|
Vascular disorders
Varicose vein
|
0.17%
1/602
|
0.00%
0/609
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
7/602
|
0.00%
0/609
|
|
Investigations
Aspartate aminotransferase increased
|
0.83%
5/602
|
0.16%
1/609
|
|
Investigations
Blood creatine phosphokinase increased
|
0.66%
4/602
|
0.00%
0/609
|
|
Investigations
Blood creatinine increased
|
0.17%
1/602
|
0.00%
0/609
|
|
Investigations
Blood glucose increased
|
1.5%
9/602
|
0.00%
0/609
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.17%
1/602
|
0.00%
0/609
|
|
Investigations
Blood potassium increased
|
0.00%
0/602
|
0.16%
1/609
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.33%
2/602
|
0.16%
1/609
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER