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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_576 |
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Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ezetimibe/simvastatin 10/40 | Experimental | Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period |
|
| atorvastatin 40 mg | Active Comparator | Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ezetimibe/simvastatin 10/40 | Drug | ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low Density Lipoprotein (LDL)-C | Baseline (Treatment Day 1), Treatment Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reaching LDL-C Target Goals of <70 mg/dL | Target LDL-C level of < 70 mg/dL (1.81 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population. | Treatment Week 6 |
| Number of Participants Reaching LDL-C Target Goal <77 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22293030 | Derived | Hing Ling PK, Civeira F, Dan AG, Hanson ME, Massaad R, De Tilleghem Cle B, Milardo C, Triscari J. Ezetimibe/simvastatin 10/40 mg versus atorvastatin 40 mg in high cardiovascular risk patients with primary hypercholesterolemia: a randomized, double-blind, active-controlled, multicenter study. Lipids Health Dis. 2012 Jan 31;11:18. doi: 10.1186/1476-511X-11-18. |
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Participants received 20 mg open-label atorvastatin during a 5-week run-in period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ezetimibe/Simvastatin 10/40 | Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period. |
| FG001 | Atorvastatin 40 mg | Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ezetimibe/Simvastatin 10/40 | Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period. |
| BG001 | Atorvastatin 40 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants Reaching LDL-C Target Goals of <70 mg/dL | Target LDL-C level of < 70 mg/dL (1.81 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population. | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available. | Posted | Number | participants | Treatment Week 6 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ezetimibe/Simvastatin 10/40 | Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary tract infection | Infections and infestations | MedDRA 13.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D000069499 | Ezetimibe, Simvastatin Drug Combination |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| atorvastatin 40 mg | Drug | atorvastatin 40 mg tablet once daily for 6 weeks |
|
|
| atorvastatin 20 mg | Drug | All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization |
|
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Target LDL-C level of < 77 mg/dL (2.00 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population. |
| Treatment Week 6 |
| Number of Participants Reaching LDL-C Target Goal <100 mg/dL | Target LDL-C level of < 100 mg/dL (2.59 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population. | Treatment Week 6 |
| Percent Change From Baseline in Total Cholesterol | Baseline (Treatment Day 1), Treatment Week 6 |
| Percent Change From Baseline in Triglycerides | Baseline (Treatment Day 1), Treatment Week 6 |
| Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol | Baseline (Treatment Day 1), Treatment Week 6 |
| Percent Change From Baseline in Non-HDL Cholesterol | Baseline (Treatment Day 1), Treatment Week 6 |
| Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio | Baseline (Treatment Day 1), Treatment Week 6 |
| Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio | Baseline (Treatment Day 1), Treatment Week 6 |
| Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio | Baseline (Treatment Day 1), Treatment Week 6 |
| Percent Change From Baseline in Apolipoprotein B | Baseline (Treatment Day 1), Treatment Week 6 |
| Percent Change From Baseline in Apolipoprotein A-1 | Baseline (Treatment Day 1), Treatment Week 6 |
| Percent Change From Baseline in Apolipoprotein B/A-1 Ratio | Baseline (Treatment Day 1), Treatment Week 6 |
| Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) | Baseline (Treatment Day 1), Treatment Week 6 |
| Withdrawal by Subject |
|
Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period. |
|
|
|
| Primary | Percent Change From Baseline in Low Density Lipoprotein (LDL)-C | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline (Treatment Day 1), Treatment Week 6 |
|
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|
|
| Secondary | Number of Participants Reaching LDL-C Target Goal <77 mg/dL | Target LDL-C level of < 77 mg/dL (2.00 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population. | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available. | Posted | Number | participants | Treatment Week 6 |
|
|
|
|
| Secondary | Number of Participants Reaching LDL-C Target Goal <100 mg/dL | Target LDL-C level of < 100 mg/dL (2.59 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population. | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with baseline and post-baseline data available. | Posted | Number | participants | Treatment Week 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in Total Cholesterol | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline (Treatment Day 1), Treatment Week 6 |
|
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|
|
| Secondary | Percent Change From Baseline in Triglycerides | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline (Treatment Day 1), Treatment Week 6 |
|
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|
|
| Secondary | Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline (Treatment Day 1), Treatment Week 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in Non-HDL Cholesterol | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline (Treatment Day 1), Treatment Week 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline (Treatment Day 1), Treatment Week 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline (Treatment Day 1), Treatment Week 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline (Treatment Day 1), Treatment Week 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in Apolipoprotein B | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline (Treatment Day 1), Treatment Week 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in Apolipoprotein A-1 | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline (Treatment Day 1), Treatment Week 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in Apolipoprotein B/A-1 Ratio | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline (Treatment Day 1), Treatment Week 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) | Participants in the Full Analysis Set (FAS) Population [all randomized participants with at least one dose of study treatment and baseline data] with percent change data available at week 6. | Posted | Least Squares Mean | 95% Confidence Interval | percent change from baseline | Baseline (Treatment Day 1), Treatment Week 6 |
|
|
|
|
| 1 |
| 119 |
| 0 |
| 119 |
| EG001 | Atorvastatin 40 mg | Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period. | 1 | 130 | 2 | 130 |
| EG002 | Placebo | One participant received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, the participant was randomized to the ezetimbe/simvastatin group, but took only pills from the bottle containing placebo to atorvastatin during the 6-week double-blind treatment period. | 0 | 1 | 1 | 1 |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
| D009750 |
| Nutritional and Metabolic Diseases |
| D019821 |
| Simvastatin |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |