Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007_588 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Shering-Plough JV Study | UNKNOWN |
A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Each patient will receive 1 active treatment dose & 2 Placebo (Pbo) doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. |
|
| 2 | Experimental | Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. |
|
| 3 | Experimental | Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. |
|
| 4 | Experimental | Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. |
|
| 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 10 mg | Drug | Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 | 12 weeks | |
| Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 | Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21029821 | Result | Foody JM, Brown WV, Zieve F, Adewale AJ, Flaim D, Lowe RS, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults >/=65 years of age with hypercholesterolemia and with or at moderately high/high risk for coronary heart disease (the VYTELD study). Am J Cardiol. 2010 Nov 1;106(9):1255-63. doi: 10.1016/j.amjcard.2010.06.051. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study evaluated patients ≥ 65 years of age at moderately high or high risk for Coronary Heart Disease (CHD), with or without atherosclerotic vascular disease. The study was a 3-week single-blind placebo run-in period and a 12-week active treatment period where patients were equally randomized to one of 5 treatment groups for 12 weeks
Phase III
First Patient In 08-Nov-2007; Last Patient Last Visit 23-Mar-2009
Eligible patients include drug-naïve patients or patients rendered naïve with the appropriate prior washout at moderately high or high risk for coronary heart disease 65 years and older.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin 10 mg | Atorvastatin (Atorva) 10 mg once daily for 12 weeks |
| FG001 | Ezetimibe 10 mg/Simvastatin 20 mg | Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Each patient will receive 1 active treatment dose & 2 Pbo doses or 2 active treatment doses & 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks. |
|
| Ezetimibe 10 mg/simvastatin 20 mg | Drug | Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks |
|
| Atorvastatin 20 mg | Drug | Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks |
|
| Ezetimibe 10 mg/simvastatin 40 mg | Drug | Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks |
|
| Atorvastatin 40 mg | Drug | Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks |
|
| 12 Weeks |
| Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12 | 12 Weeks |
| Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12 | Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring. | 12 Weeks |
| Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 | Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia. | 12 Weeks |
| FG002 | Atorvastatin 20 mg | Atorvastatin 20 mg once daily for 12 weeks |
| FG003 | Ezetimibe 10 mg/Simvastatin 40 mg | Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks |
| FG004 | Atorva 40 mg | Atorvastatin 40 mg once daily for 12 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin 10 mg | Atorvastatin (Atorva) 10 mg once daily for 12 weeks |
| BG001 | Ezetimibe 10 mg/Simvastatin 20 mg | Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks |
| BG002 | Atorvastatin 20 mg | Atorvastatin 20 mg once daily for 12 weeks |
| BG003 | Ezetimibe 10 mg/Simvastatin 40 mg | Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks |
| BG004 | Atorva 40 mg | Atorvastatin 40 mg once daily for 12 weeks |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12 | Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change in LDL-C | Baseline and 12 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12 | Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | Mean | Standard Error | Percent of Patients | 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 | Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia. | Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | Mean | Standard Error | Percent of Patients | 12 Weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12 | Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | Mean | Standard Error | Percent of Patients | 12 Weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12 | Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring. | Patients with High Risk for CHD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | Mean | Standard Error | Percent of Patients | 12 Weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12 | Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia. | Patients with AVD in the Full Analysis Set (FAS). The FAS population includes all randomized patients with baseline (BL) value and at least one valid after-BL value. After-BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis. | Posted | Mean | Standard Error | Percent of Patients | 12 Weeks |
|
Not provided
AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin 10 mg | Atorvastatin (Atorva) 10 mg once daily for 12 weeks | 4 | 257 | 26 | 257 | ||
| EG001 | Ezetimibe 10 mg/Simvastatin 20 mg | Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks | 8 | 256 | 32 | 256 | ||
| EG002 | Atorvastatin 20 mg | Atorvastatin 20 mg once daily for 12 weeks | 3 | 258 | 26 | 258 | ||
| EG003 | Ezetimibe 10 mg/Simvastatin 40 mg | Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks | 3 | 257 | 32 | 257 | ||
| EG004 | Atorvastatin 40 mg | Atorvastatin 40 mg once daily for 12 weeks | 5 | 256 | 30 | 256 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AV dissociation | Cardiac disorders | Non-systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Ventricular fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal strangulated hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Colitis ischaemic | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diverticulum intestinal | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Mechanical complication of implant | General disorders | Non-systematic Assessment |
| ||
| Oedema peripheral | General disorders | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Meniscus lesion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Soft tissue injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Intervertebral disc protrusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Panic attack | Psychiatric disorders | Non-systematic Assessment |
| ||
| Pickwickian syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
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.
| 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 |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D000069438 | Ezetimibe |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D001384 | Azetidines |
| D001385 | Azetines |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Black |
|
| Other |
|
| White |
|
|
| ANCOVA |
ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect. |
| <0.001 |
Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons. |
| Mean Difference (Final Values) |
| -7.5 |
| Standard Error of the Mean |
| 1.4 |
| 95 |
| -10.3 |
| -4.8 |
| Superiority or Other (legacy) |
| ANCOVA | ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect. | <0.001 | Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons. | Mean Difference (Final Values) | -8.2 | Standard Error of the Mean | 1.4 | 95 | -11.0 | -5.5 | Superiority or Other (legacy) |
Atorvastatin 40 mg once daily for 12 weeks
|
|
|
Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks |
| OG004 | Atorva 40 mg | Atorvastatin 40 mg once daily for 12 weeks |
|
|
|
Atorvastatin 40 mg once daily for 12 weeks
|
|
|
| OG004 | Atorva 40 mg | Atorvastatin 40 mg once daily for 12 weeks |
|
|
|
Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
| OG004 | Atorva 40 mg | Atorvastatin 40 mg once daily for 12 weeks |
|
|
|