Trial Outcomes & Findings for A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease (NCT NCT01674712)
NCT ID: NCT01674712
Last Updated: 2014-12-11
Results Overview
Collection and measurement of blood samples.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
575 participants
Primary outcome timeframe
from baseline to 12 weeks of treatment
Results posted on
2014-12-11
Participant Flow
Participant milestones
| Measure |
Fenofibrate/Simvastatin 145/20 mg
Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
|
Simvastatin 20 mg
Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
|
Fenofibrate/Simvastatin 145/40 mg
Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
|
Simvastatin 40 mg
Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
|
Fenofibrate 145 mg
Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
114
|
117
|
115
|
116
|
113
|
|
Overall Study
Full Analysis Subject Sample
|
109
|
114
|
110
|
112
|
111
|
|
Overall Study
Safety Subject Sample
|
111
|
117
|
113
|
115
|
112
|
|
Overall Study
COMPLETED
|
104
|
108
|
106
|
108
|
102
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
9
|
8
|
11
|
Reasons for withdrawal
| Measure |
Fenofibrate/Simvastatin 145/20 mg
Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
|
Simvastatin 20 mg
Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
|
Fenofibrate/Simvastatin 145/40 mg
Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
|
Simvastatin 40 mg
Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
|
Fenofibrate 145 mg
Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
3
|
4
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
5
|
4
|
3
|
|
Overall Study
Administrative
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease
Baseline characteristics by cohort
| Measure |
Fenofibrate/Simvastatin 145/20 mg
n=109 Participants
Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
|
Simvastatin 20 mg
n=114 Participants
Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
|
Fenofibrate/Simvastatin 145/40 mg
n=110 Participants
Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
|
Simvastatin 40 mg
n=112 Participants
Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
|
Fenofibrate 145 mg
n=111 Participants
Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
|
Total
n=556 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 10 • n=93 Participants
|
60.5 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
60.4 years
STANDARD_DEVIATION 8.1 • n=27 Participants
|
59.3 years
STANDARD_DEVIATION 9.1 • n=483 Participants
|
60.4 years
STANDARD_DEVIATION 9.0 • n=36 Participants
|
60.0 years
STANDARD_DEVIATION 9.1 • n=10 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
39 Participants
n=483 Participants
|
38 Participants
n=36 Participants
|
198 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
73 Participants
n=483 Participants
|
73 Participants
n=36 Participants
|
358 Participants
n=10 Participants
|
|
Region of Enrollment
Czech Republic
|
22 participants
n=93 Participants
|
22 participants
n=4 Participants
|
22 participants
n=27 Participants
|
23 participants
n=483 Participants
|
21 participants
n=36 Participants
|
110 participants
n=10 Participants
|
|
Region of Enrollment
Mexico
|
7 participants
n=93 Participants
|
9 participants
n=4 Participants
|
8 participants
n=27 Participants
|
7 participants
n=483 Participants
|
8 participants
n=36 Participants
|
39 participants
n=10 Participants
|
|
Region of Enrollment
Argentina
|
19 participants
n=93 Participants
|
22 participants
n=4 Participants
|
19 participants
n=27 Participants
|
20 participants
n=483 Participants
|
21 participants
n=36 Participants
|
101 participants
n=10 Participants
|
|
Region of Enrollment
Poland
|
7 participants
n=93 Participants
|
9 participants
n=4 Participants
|
8 participants
n=27 Participants
|
10 participants
n=483 Participants
|
7 participants
n=36 Participants
|
41 participants
n=10 Participants
|
|
Region of Enrollment
Romania
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
6 participants
n=27 Participants
|
5 participants
n=483 Participants
|
4 participants
n=36 Participants
|
27 participants
n=10 Participants
|
|
Region of Enrollment
Russian Federation
|
18 participants
n=93 Participants
|
17 participants
n=4 Participants
|
16 participants
n=27 Participants
|
16 participants
n=483 Participants
|
17 participants
n=36 Participants
|
84 participants
n=10 Participants
|
|
Region of Enrollment
Germany
|
30 participants
n=93 Participants
|
29 participants
n=4 Participants
|
31 participants
n=27 Participants
|
31 participants
n=483 Participants
|
33 participants
n=36 Participants
|
154 participants
n=10 Participants
|
|
Triglycerides (mmol/L)
|
2.8 mmol/L
STANDARD_DEVIATION 1.1 • n=93 Participants
|
2.5 mmol/L
STANDARD_DEVIATION 1.0 • n=4 Participants
|
2.7 mmol/L
STANDARD_DEVIATION 1.4 • n=27 Participants
|
2.7 mmol/L
STANDARD_DEVIATION 1.0 • n=483 Participants
|
2.9 mmol/L
STANDARD_DEVIATION 1.3 • n=36 Participants
|
2.7 mmol/L
STANDARD_DEVIATION 1.1 • n=10 Participants
|
|
LDL Cholesterol (mmol/L)
|
2.6 mmol/L
STANDARD_DEVIATION 0.5 • n=93 Participants
|
2.6 mmol/L
STANDARD_DEVIATION 0.4 • n=4 Participants
|
2.6 mmol/L
STANDARD_DEVIATION 0.4 • n=27 Participants
|
2.7 mmol/L
STANDARD_DEVIATION 0.4 • n=483 Participants
|
2.7 mmol/L
STANDARD_DEVIATION 0.5 • n=36 Participants
|
2.7 mmol/L
STANDARD_DEVIATION 0.5 • n=10 Participants
|
|
HDL Cholesterol (mmol/L)
|
1.1 mmol/L
STANDARD_DEVIATION 0.3 • n=93 Participants
|
1.2 mmol/L
STANDARD_DEVIATION 0.3 • n=4 Participants
|
1.2 mmol/L
STANDARD_DEVIATION 0.3 • n=27 Participants
|
1.2 mmol/L
STANDARD_DEVIATION 0.3 • n=483 Participants
|
1.2 mmol/L
STANDARD_DEVIATION 0.3 • n=36 Participants
|
1.2 mmol/L
STANDARD_DEVIATION 0.3 • n=10 Participants
|
PRIMARY outcome
Timeframe: from baseline to 12 weeks of treatmentPopulation: The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.
Collection and measurement of blood samples.
Outcome measures
| Measure |
Fenofibrate/Simvastatin 145/20 mg
n=96 Participants
Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
|
Simvastatin 20 mg
n=102 Participants
Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
|
Fenofibrate/Simvastatin 145/40 mg
n=97 Participants
Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
|
Simvastatin 40 mg
n=101 Participants
Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
|
Fenofibrate 145 mg
n=93 Participants
Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
|
|---|---|---|---|---|---|
|
Percentage of Change of TG (Triglyceride)
|
-30.6 percentage of change
Standard Deviation 25.8
|
10.7 percentage of change
Standard Deviation 48.8
|
-27.3 percentage of change
Standard Deviation 35.9
|
-2.9 percentage of change
Standard Deviation 34.3
|
-21.6 percentage of change
Standard Deviation 34.2
|
PRIMARY outcome
Timeframe: from baseline to 12 weeks of treatmentPopulation: The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.
Collection and measurement of blood samples.
Outcome measures
| Measure |
Fenofibrate/Simvastatin 145/20 mg
n=96 Participants
Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
|
Simvastatin 20 mg
n=102 Participants
Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
|
Fenofibrate/Simvastatin 145/40 mg
n=97 Participants
Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
|
Simvastatin 40 mg
n=101 Participants
Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
|
Fenofibrate 145 mg
n=93 Participants
Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
|
|---|---|---|---|---|---|
|
Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)
|
9.0 percentage of change
Standard Deviation 16.8
|
0.3 percentage of change
Standard Deviation 12.1
|
8.8 percentage of change
Standard Deviation 16.5
|
2.2 percentage of change
Standard Deviation 12.5
|
7.6 percentage of change
Standard Deviation 15.7
|
PRIMARY outcome
Timeframe: from baseline to 12 weeks of treatmentPopulation: The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.
Collection and measurement of blood samples.
Outcome measures
| Measure |
Fenofibrate/Simvastatin 145/20 mg
n=96 Participants
Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
|
Simvastatin 20 mg
n=102 Participants
Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
|
Fenofibrate/Simvastatin 145/40 mg
n=97 Participants
Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
|
Simvastatin 40 mg
n=101 Participants
Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
|
Fenofibrate 145 mg
n=93 Participants
Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
|
|---|---|---|---|---|---|
|
Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)
|
1.9 percentage of change
Standard Deviation 25.4
|
-2.0 percentage of change
Standard Deviation 24.8
|
-6.1 percentage of change
Standard Deviation 26.2
|
-8.1 percentage of change
Standard Deviation 25.8
|
30.3 percentage of change
Standard Deviation 35.6
|
SECONDARY outcome
Timeframe: 12 weeksCollection and measurement of blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksCollection and measurement of blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksCollection and measurement of blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksCollection and measurement of blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksCollection and measurement of blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksCollection and measurement of blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksCollection and measurement of blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksCollection and measurement of blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksCollection and measurement of blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksCollection and measurement of blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksCollection and measurement of blood samples
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksCollection and measurement of blood samples
Outcome measures
Outcome data not reported
Adverse Events
Fenofibrate/Simvastatin 145/20 mg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Simvastatin 20 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Fenofibrate/Simvastatin 145/40 mg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Simvastatin 40 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Fenofibrate 145 mg
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fenofibrate/Simvastatin 145/20 mg
n=111 participants at risk
Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
|
Simvastatin 20 mg
n=117 participants at risk
Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
|
Fenofibrate/Simvastatin 145/40 mg
n=113 participants at risk
Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
|
Simvastatin 40 mg
n=115 participants at risk
Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
|
Fenofibrate 145 mg
n=112 participants at risk
Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
|
|---|---|---|---|---|---|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.90%
1/111 • Number of events 1
|
0.00%
0/117
|
0.00%
0/113
|
0.00%
0/115
|
0.00%
0/112
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/111
|
0.00%
0/117
|
0.00%
0/113
|
0.00%
0/115
|
0.89%
1/112 • Number of events 1
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/111
|
0.00%
0/117
|
0.88%
1/113 • Number of events 1
|
0.00%
0/115
|
0.00%
0/112
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/111
|
0.85%
1/117 • Number of events 1
|
0.00%
0/113
|
0.00%
0/115
|
0.00%
0/112
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/111
|
0.85%
1/117 • Number of events 1
|
0.00%
0/113
|
0.00%
0/115
|
0.00%
0/112
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.00%
0/111
|
0.00%
0/117
|
0.00%
0/113
|
0.00%
0/115
|
0.89%
1/112 • Number of events 1
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.00%
0/111
|
0.00%
0/117
|
0.00%
0/113
|
0.87%
1/115 • Number of events 1
|
0.00%
0/112
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.90%
1/111 • Number of events 1
|
0.00%
0/117
|
0.00%
0/113
|
0.00%
0/115
|
0.00%
0/112
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.00%
0/111
|
0.85%
1/117 • Number of events 1
|
0.00%
0/113
|
0.00%
0/115
|
0.00%
0/112
|
|
Ear and labyrinth disorders
VESTIBULAR DISORDER
|
0.00%
0/111
|
0.00%
0/117
|
0.88%
1/113 • Number of events 1
|
0.00%
0/115
|
0.00%
0/112
|
|
Gastrointestinal disorders
INTESTINAL HAEMORRHAGE
|
0.00%
0/111
|
0.00%
0/117
|
0.88%
1/113 • Number of events 1
|
0.00%
0/115
|
0.00%
0/112
|
|
Gastrointestinal disorders
UMBILICAL HERNIA, OBSTRUCTIVE
|
0.00%
0/111
|
0.00%
0/117
|
0.88%
1/113 • Number of events 1
|
0.00%
0/115
|
0.00%
0/112
|
|
Injury, poisoning and procedural complications
NON-SITE SPECIFIC INJURIES NEC
|
0.00%
0/111
|
0.00%
0/117
|
0.88%
1/113 • Number of events 2
|
0.00%
0/115
|
0.00%
0/112
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.00%
0/111
|
0.00%
0/117
|
0.00%
0/113
|
0.00%
0/115
|
0.89%
1/112 • Number of events 1
|
|
Renal and urinary disorders
HAEMATURIA
|
0.90%
1/111 • Number of events 1
|
0.00%
0/117
|
0.00%
0/113
|
0.00%
0/115
|
0.00%
0/112
|
|
Surgical and medical procedures
DIABETES MELLITUS MANAGEMENT
|
0.00%
0/111
|
0.00%
0/117
|
0.00%
0/113
|
0.87%
1/115 • Number of events 1
|
0.00%
0/112
|
Other adverse events
| Measure |
Fenofibrate/Simvastatin 145/20 mg
n=111 participants at risk
Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
|
Simvastatin 20 mg
n=117 participants at risk
Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
|
Fenofibrate/Simvastatin 145/40 mg
n=113 participants at risk
Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
|
Simvastatin 40 mg
n=115 participants at risk
Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
|
Fenofibrate 145 mg
n=112 participants at risk
Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
0.90%
1/111
|
1.7%
2/117
|
1.8%
2/113
|
0.00%
0/115
|
4.5%
5/112
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.90%
1/111
|
0.00%
0/117
|
0.88%
1/113
|
2.6%
3/115
|
2.7%
3/112
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
3.6%
4/111
|
0.00%
0/117
|
0.88%
1/113
|
0.87%
1/115
|
0.89%
1/112
|
|
Infections and infestations
GASTROENTERITIS
|
0.90%
1/111
|
1.7%
2/117
|
0.00%
0/113
|
0.00%
0/115
|
3.6%
4/112
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.90%
1/111
|
0.00%
0/117
|
0.00%
0/113
|
3.5%
4/115
|
0.89%
1/112
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/111
|
2.6%
3/117
|
0.00%
0/113
|
0.87%
1/115
|
0.89%
1/112
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the PI shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. If the Sponsor requests, the PI shall remove any Confidential Information (other than Study results) prior to submitting or presenting the materials.
- Publication restrictions are in place
Restriction type: OTHER