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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

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ClinicalTrials.gov Identifier: NCT01674712
Recruitment Status : Completed
First Posted : August 29, 2012
Results First Posted : October 30, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dyslipidemia
Interventions Drug: Fixed Combination of Fenofibrate/simvastatin 145/20 mg
Drug: Simvastatin 20 mg
Drug: Fenofibrate 145 mg
Drug: Fixed Combination of Fenofibrate/simvastatin 145/40 mg
Drug: Simvastatin 40 mg
Enrollment 575
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fenofibrate/Simvastatin 145/20 mg Simvastatin 20 mg Fenofibrate/Simvastatin 145/40 mg Simvastatin 40 mg Fenofibrate 145 mg
Hide Arm/Group Description Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
Period Title: Overall Study
Started 114 117 115 116 113
Full Analysis Subject Sample 109 114 110 112 111
Safety Subject Sample 111 117 113 115 112
Completed 104 108 106 108 102
Not Completed 10 9 9 8 11
Reason Not Completed
Adverse Event             5             6             3             4             6
Lost to Follow-up             1             0             0             0             0
Protocol Violation             2             0             0             0             0
Withdrawal by Subject             2             2             5             4             3
Administrative             0             1             0             0             1
Lack of Efficacy             0             0             1             0             1
Arm/Group Title Fenofibrate/Simvastatin 145/20 mg Simvastatin 20 mg Fenofibrate/Simvastatin 145/40 mg Simvastatin 40 mg Fenofibrate 145 mg Total
Hide Arm/Group Description Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 109 114 110 112 111 556
Hide Baseline Analysis Population Description
Full analysis subject sample
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 114 participants 110 participants 112 participants 111 participants 556 participants
59.6  (10) 60.5  (9.3) 60.4  (8.1) 59.3  (9.1) 60.4  (9.0) 60.0  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 114 participants 110 participants 112 participants 111 participants 556 participants
Female
38
  34.9%
40
  35.1%
43
  39.1%
39
  34.8%
38
  34.2%
198
  35.6%
Male
71
  65.1%
74
  64.9%
67
  60.9%
73
  65.2%
73
  65.8%
358
  64.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants 114 participants 110 participants 112 participants 111 participants 556 participants
Czech Republic 22 22 22 23 21 110
Mexico 7 9 8 7 8 39
Argentina 19 22 19 20 21 101
Poland 7 9 8 10 7 41
Romania 6 6 6 5 4 27
Russian Federation 18 17 16 16 17 84
Germany 30 29 31 31 33 154
Triglycerides (mmol/L)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 109 participants 114 participants 110 participants 112 participants 111 participants 556 participants
2.8  (1.1) 2.5  (1.0) 2.7  (1.4) 2.7  (1.0) 2.9  (1.3) 2.7  (1.1)
LDL Cholesterol (mmol/L)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 109 participants 114 participants 110 participants 112 participants 111 participants 556 participants
2.6  (0.5) 2.6  (0.4) 2.6  (0.4) 2.7  (0.4) 2.7  (0.5) 2.7  (0.5)
HDL Cholesterol (mmol/L)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 109 participants 114 participants 110 participants 112 participants 111 participants 556 participants
1.1  (0.3) 1.2  (0.3) 1.2  (0.3) 1.2  (0.3) 1.2  (0.3) 1.2  (0.3)
1.Primary Outcome
Title Percentage of Change of TG (Triglyceride)
Hide Description Collection and measurement of blood samples.
Time Frame from baseline to 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.
Arm/Group Title Fenofibrate/Simvastatin 145/20 mg Simvastatin 20 mg Fenofibrate/Simvastatin 145/40 mg Simvastatin 40 mg Fenofibrate 145 mg
Hide Arm/Group Description:
Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
Overall Number of Participants Analyzed 96 102 97 101 93
Mean (Standard Deviation)
Unit of Measure: percentage of change
-30.6  (25.8) 10.7  (48.8) -27.3  (35.9) -2.9  (34.3) -21.6  (34.2)
2.Primary Outcome
Title Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)
Hide Description Collection and measurement of blood samples.
Time Frame from baseline to 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.
Arm/Group Title Fenofibrate/Simvastatin 145/20 mg Simvastatin 20 mg Fenofibrate/Simvastatin 145/40 mg Simvastatin 40 mg Fenofibrate 145 mg
Hide Arm/Group Description:
Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
Overall Number of Participants Analyzed 96 102 97 101 93
Mean (Standard Deviation)
Unit of Measure: percentage of change
9.0  (16.8) 0.3  (12.1) 8.8  (16.5) 2.2  (12.5) 7.6  (15.7)
3.Primary Outcome
Title Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)
Hide Description Collection and measurement of blood samples.
Time Frame from baseline to 12 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.
Arm/Group Title Fenofibrate/Simvastatin 145/20 mg Simvastatin 20 mg Fenofibrate/Simvastatin 145/40 mg Simvastatin 40 mg Fenofibrate 145 mg
Hide Arm/Group Description:
Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
Overall Number of Participants Analyzed 96 102 97 101 93
Mean (Standard Deviation)
Unit of Measure: percentage of change
1.9  (25.4) -2.0  (24.8) -6.1  (26.2) -8.1  (25.8) 30.3  (35.6)
4.Secondary Outcome
Title Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline
Hide Description Collection and measurement of blood samples
Time Frame 12 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Percentage of TC (Triglyceride) From Baseline
Hide Description Collection and measurement of blood samples
Time Frame 12 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Percentage of Apolipoprotein AI From Baseline
Hide Description Collection and measurement of blood samples
Time Frame 12 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Percentage of Apolipoprotein B From Baseline
Hide Description Collection and measurement of blood samples
Time Frame 12 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline
Hide Description Collection and measurement of blood samples
Time Frame 12 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)
Hide Description Collection and measurement of blood samples
Time Frame 12 weeks
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Adverse Events
Hide Description Collection and measurement of blood samples
Time Frame 12 weeks
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Creatine Kinase (CK)
Hide Description Collection and measurement of blood samples
Time Frame 12 weeks
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Alanine Aminotransferase (ALT)
Hide Description Collection and measurement of blood samples
Time Frame 12 weeks
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Plasma Creatinine
Hide Description Collection and measurement of blood samples
Time Frame 12 weeks
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Total Bilirubin
Hide Description Collection and measurement of blood samples
Time Frame 12 weeks
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Cystatin C
Hide Description Collection and measurement of blood samples
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fenofibrate/Simvastatin 145/20 mg Simvastatin 20 mg Fenofibrate/Simvastatin 145/40 mg Simvastatin 40 mg Fenofibrate 145 mg
Hide Arm/Group Description Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
All-Cause Mortality
Fenofibrate/Simvastatin 145/20 mg Simvastatin 20 mg Fenofibrate/Simvastatin 145/40 mg Simvastatin 40 mg Fenofibrate 145 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fenofibrate/Simvastatin 145/20 mg Simvastatin 20 mg Fenofibrate/Simvastatin 145/40 mg Simvastatin 40 mg Fenofibrate 145 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/111 (2.70%)      3/117 (2.56%)      3/113 (2.65%)      1/115 (0.87%)      3/112 (2.68%)    
Cardiac disorders           
ACUTE CORONARY SYNDROME  1  1/111 (0.90%)  1 0/117 (0.00%)  0 0/113 (0.00%)  0 0/115 (0.00%)  0 0/112 (0.00%)  0
ACUTE MYOCARDIAL INFARCTION  1  0/111 (0.00%)  0 0/117 (0.00%)  0 0/113 (0.00%)  0 0/115 (0.00%)  0 1/112 (0.89%)  1
ANGINA PECTORIS  1  0/111 (0.00%)  0 0/117 (0.00%)  0 1/113 (0.88%)  1 0/115 (0.00%)  0 0/112 (0.00%)  0
MYOCARDIAL INFARCTION  1 [1]  0/111 (0.00%)  0 1/117 (0.85%)  1 0/113 (0.00%)  0 0/115 (0.00%)  0 0/112 (0.00%)  0
Ear and labyrinth disorders           
VESTIBULAR DISORDER  1  0/111 (0.00%)  0 0/117 (0.00%)  0 1/113 (0.88%)  1 0/115 (0.00%)  0 0/112 (0.00%)  0
Gastrointestinal disorders           
INTESTINAL HAEMORRHAGE  1  0/111 (0.00%)  0 0/117 (0.00%)  0 1/113 (0.88%)  1 0/115 (0.00%)  0 0/112 (0.00%)  0
UMBILICAL HERNIA, OBSTRUCTIVE  1  0/111 (0.00%)  0 0/117 (0.00%)  0 1/113 (0.88%)  1 0/115 (0.00%)  0 0/112 (0.00%)  0
Injury, poisoning and procedural complications           
NON-SITE SPECIFIC INJURIES NEC  1 [2]  0/111 (0.00%)  0 0/117 (0.00%)  0 1/113 (0.88%)  2 0/115 (0.00%)  0 0/112 (0.00%)  0
Metabolism and nutrition disorders           
DIABETES MELLITUS  1  0/111 (0.00%)  0 1/117 (0.85%)  1 0/113 (0.00%)  0 0/115 (0.00%)  0 0/112 (0.00%)  0
DIABETES MELLITUS INADEQUATE CONTROL  1  0/111 (0.00%)  0 0/117 (0.00%)  0 0/113 (0.00%)  0 0/115 (0.00%)  0 1/112 (0.89%)  1
TYPE 2 DIABETES MELLITUS  1  0/111 (0.00%)  0 0/117 (0.00%)  0 0/113 (0.00%)  0 1/115 (0.87%)  1 0/112 (0.00%)  0
Musculoskeletal and connective tissue disorders           
BURSITIS  1  0/111 (0.00%)  0 0/117 (0.00%)  0 0/113 (0.00%)  0 0/115 (0.00%)  0 1/112 (0.89%)  1
Nervous system disorders           
CEREBROVASCULAR ACCIDENT  1  1/111 (0.90%)  1 0/117 (0.00%)  0 0/113 (0.00%)  0 0/115 (0.00%)  0 0/112 (0.00%)  0
LOSS OF CONSCIOUSNESS  1  0/111 (0.00%)  0 1/117 (0.85%)  1 0/113 (0.00%)  0 0/115 (0.00%)  0 0/112 (0.00%)  0
Renal and urinary disorders           
HAEMATURIA  1  1/111 (0.90%)  1 0/117 (0.00%)  0 0/113 (0.00%)  0 0/115 (0.00%)  0 0/112 (0.00%)  0
Surgical and medical procedures           
DIABETES MELLITUS MANAGEMENT  1  0/111 (0.00%)  0 0/117 (0.00%)  0 0/113 (0.00%)  0 1/115 (0.87%)  1 0/112 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra
[1]
One Myocardial Infarction was fatal.
[2]
One Injury was fatal.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Fenofibrate/Simvastatin 145/20 mg Simvastatin 20 mg Fenofibrate/Simvastatin 145/40 mg Simvastatin 40 mg Fenofibrate 145 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/111 (7.21%)      7/117 (5.98%)      4/113 (3.54%)      9/115 (7.83%)      15/112 (13.39%)    
Gastrointestinal disorders           
DIARRHOEA  1  1/111 (0.90%)  2/117 (1.71%)  2/113 (1.77%)  0/115 (0.00%)  5/112 (4.46%) 
DYSPEPSIA  1  1/111 (0.90%)  0/117 (0.00%)  0/113 (0.00%)  4/115 (3.48%)  1/112 (0.89%) 
Infections and infestations           
NASOPHARYNGITIS  1  1/111 (0.90%)  0/117 (0.00%)  1/113 (0.88%)  3/115 (2.61%)  3/112 (2.68%) 
GASTROENTERITIS  1  1/111 (0.90%)  2/117 (1.71%)  0/113 (0.00%)  0/115 (0.00%)  4/112 (3.57%) 
Investigations           
BLOOD CREATINE PHOSPHOKINASE INCREASED  1  4/111 (3.60%)  0/117 (0.00%)  1/113 (0.88%)  1/115 (0.87%)  1/112 (0.89%) 
Respiratory, thoracic and mediastinal disorders           
COUGH  1  0/111 (0.00%)  3/117 (2.56%)  0/113 (0.00%)  1/115 (0.87%)  1/112 (0.89%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
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.
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.
Results Point of Contact
Name/Title: Associate Director Clinical Services
Organization: Abbott
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01674712     History of Changes
Other Study ID Numbers: M13-377
2011-005924-16 ( EudraCT Number )
First Submitted: June 26, 2012
First Posted: August 29, 2012
Results First Submitted: October 27, 2014
Results First Posted: October 30, 2014
Last Update Posted: December 11, 2014