Trial Outcomes & Findings for A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED) (NCT NCT00496730)
NCT ID: NCT00496730
Last Updated: 2024-05-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
256 participants
Primary outcome timeframe
Baseline and 8 Weeks
Results posted on
2024-05-16
Participant Flow
Patients were recruited between June 2007 and May 2008.
Patients who have Metabolic syndrome and Hypercholesterolemia had 4 weeks wash-out period were enrolled in this study. The eligible patients was allocated to one of Vytorin 10/20 mg or Atorvastatin 10 mg group.
Participant milestones
| Measure |
Vytorin
simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
|
Atorvastatin
atorvastatin 10 mg; tablet, once daily, 8 Weeks
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
126
|
|
Overall Study
COMPLETED
|
124
|
121
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Vytorin
simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
|
Atorvastatin
atorvastatin 10 mg; tablet, once daily, 8 Weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Vytorin
n=130 Participants
simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
|
Atorvastatin
n=126 Participants
atorvastatin 10 mg; tablet, once daily, 8 Weeks
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.96 years
STANDARD_DEVIATION 9.42 • n=93 Participants
|
60.26 years
STANDARD_DEVIATION 9.44 • n=4 Participants
|
59.61 years
STANDARD_DEVIATION 9.44 • n=27 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
177 Participants
n=27 Participants
|
|
Body Mass Index (BMI)
|
26.75 kg/m^2
STANDARD_DEVIATION 3.59 • n=93 Participants
|
26.45 kg/m^2
STANDARD_DEVIATION 3.34 • n=4 Participants
|
26.61 kg/m^2
STANDARD_DEVIATION 3.46 • n=27 Participants
|
|
Diastolic Blood Pressure
|
81.01 mm Hg
STANDARD_DEVIATION 8.47 • n=93 Participants
|
82.11 mm Hg
STANDARD_DEVIATION 8.49 • n=4 Participants
|
81.55 mm Hg
STANDARD_DEVIATION 8.48 • n=27 Participants
|
|
LDL-C (low-Density-Lipoprotein-Cholesterol)
|
159.95 mg/dL
STANDARD_DEVIATION 30.33 • n=93 Participants
|
159.95 mg/dL
STANDARD_DEVIATION 27.34 • n=4 Participants
|
159.95 mg/dL
STANDARD_DEVIATION 28.84 • n=27 Participants
|
|
Systolic Blood Pressure
|
130.81 mm Hg
STANDARD_DEVIATION 13.91 • n=93 Participants
|
129.85 mm Hg
STANDARD_DEVIATION 14.51 • n=4 Participants
|
130.34 mm Hg
STANDARD_DEVIATION 14.19 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 WeeksPopulation: All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.
Outcome measures
| Measure |
Vytorin
n=124 Participants
simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
|
Atorvastatin
n=121 Participants
atorvastatin 10 mg; tablet, once daily, 8 Weeks
|
|---|---|---|
|
Mean Percent Change of Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline After 8 Weeks.
|
-49.29 Percent of Baseline Value
Standard Deviation 15.22
|
-38.05 Percent of Baseline Value
Standard Deviation 12.28
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.
Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment. LDL-C goal is based on National Cholesterol Education Program (NCEP) III guideline (LDL-C goals and cutpoints for therapeutic life changes and drug Therapy in different risk).
Outcome measures
| Measure |
Vytorin
n=124 Participants
simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
|
Atorvastatin
n=121 Participants
atorvastatin 10 mg; tablet, once daily, 8 Weeks
|
|---|---|---|
|
Number of Patients Attaining LDL-C Goal After 8 Weeks Treatment.
|
105 Participants attaining LDL-C goal
|
93 Participants attaining LDL-C goal
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 8Population: All patient treated(APT) approach which included all patients who had baseline measured right before randomization, have taken the study drug more than once after randomization and have one measurement after the initiation of the treatment.
Outcome measures
| Measure |
Vytorin
n=124 Participants
simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
|
Atorvastatin
n=121 Participants
atorvastatin 10 mg; tablet, once daily, 8 Weeks
|
|---|---|---|
|
Change in Lower Density Lipoprotein Cholesterol From Baseline After 8 Weeks.
|
83.52 mg/dL
Standard Deviation 33.84
|
98.27 mg/dL
Standard Deviation 21.82
|
Adverse Events
Vytorin
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Atorvastatin
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vytorin
simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
|
Atorvastatin
atorvastatin 10 mg; tablet, once daily, 8 Weeks
|
|---|---|---|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/124
|
0.83%
1/121 • Number of events 2
|
|
General disorders
Death
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
General disorders
Pyrexia
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
Other adverse events
| Measure |
Vytorin
simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
|
Atorvastatin
atorvastatin 10 mg; tablet, once daily, 8 Weeks
|
|---|---|---|
|
Investigations
Hepatic enzyme increased
|
1.6%
2/124 • Number of events 3
|
2.5%
3/121 • Number of events 4
|
|
Investigations
High Density lipoprotein decreased
|
1.6%
2/124 • Number of events 2
|
4.1%
5/121 • Number of events 5
|
|
Investigations
Blood Insulin Increased
|
1.6%
2/124 • Number of events 2
|
0.00%
0/121
|
|
Investigations
Blood creatine phosphokinase increased
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Investigations
Bood Urea Increased
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.8%
6/124 • Number of events 6
|
5.0%
6/121 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.2%
4/124 • Number of events 4
|
2.5%
3/121 • Number of events 3
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.6%
2/124 • Number of events 2
|
0.83%
1/121 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
2/124 • Number of events 2
|
0.83%
1/121 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
2/124 • Number of events 2
|
2.5%
3/121 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Gastrointestinal disorders
Ascites
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Gastrointestinal disorders
Nausea
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/124
|
1.7%
2/121 • Number of events 3
|
|
Gastrointestinal disorders
Toothache
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.6%
2/124 • Number of events 2
|
2.5%
3/121 • Number of events 3
|
|
Nervous system disorders
Hypoaesthesia
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Nervous system disorders
Neurological symptom
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Nervous system disorders
Dizziness
|
0.00%
0/124
|
2.5%
3/121 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
General disorders
Death
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pyrexia
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.81%
1/124 • Number of events 1
|
2.5%
3/121 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Renal and urinary disorders
Dysuria
|
0.81%
1/124 • Number of events 1
|
0.00%
0/121
|
|
Renal and urinary disorders
Tinnitus
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Eye disorders
Myodesopsia
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/124
|
0.83%
1/121 • Number of events 1
|
Additional Information
Executive Vice President, Clinical and Quantitative Sciences
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place