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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_091 |
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To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 - Arm 1 | Active Comparator | ezetimibe/simvastatin combination tablet + niacin (ER) |
|
| Part 1 -Arm 2 | Active Comparator | ezetimibe/simvastatin |
|
| Part 1 - Arm 3 | Active Comparator | Niacin (ER) |
|
| Part 2 - Arm 1 | Active Comparator | ezetimibe/simvastatin combination tablet + niacin (ER) |
|
| Part 2 - Arm 2 | Placebo Comparator | ezetimibe/simvastatin combination tablet + niacin (Pbo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: ezetimibe/simvastatin + niacin (ER) | Drug | ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline | Baseline and 24 Weeks |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline | Baseline and 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18420099 | Background | Guyton JR, Brown BG, Fazio S, Polis A, Tomassini JE, Tershakovec AM. Lipid-altering efficacy and safety of ezetimibe/simvastatin coadministered with extended-release niacin in patients with type IIa or type IIb hyperlipidemia. J Am Coll Cardiol. 2008 Apr 22;51(16):1564-72. doi: 10.1016/j.jacc.2008.03.003. | |
| 23926117 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Niacin | (Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg. Patients in this treatment group were ramdomly reassigned for Part 2 of the study to one of two treatment groups- two-thirds of the patients enrolled in the niacin treatment group were randomly assigned to receive ezetimibe/simvastatin + niacin (ER) and the other one-third were randomly assigned to receive ezetimibe/simvastatin alone. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator: Placebo to ezetimibe/simvastatin | Drug | ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks. |
|
| Comparator: niacin (ER) tablet | Drug | niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks |
|
| Comparator: ezetimibe (+) simvastatin | Drug | ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks. |
|
| Comparator: Placebo to Niacin (ER) | Drug | Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks. |
|
| Comparator: ezetimibe/simvastatin and niacin (ER) | Drug | ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be ~40 additional weeks for a total of 64 weeks |
|
| Comparator: ezetimibe and simvastatin | Drug | ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks |
|
| Comparator: Placebo to niacin (ER) | Drug | Niacin (ER) (Pbo) tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks |
|
| Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) |
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline |
| Baseline and 24 weeks |
| Percent Change From Baseline in Triglycerides (TG) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline | baseline and 24 Weeks |
| Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline | Baseline and 64 weeks |
| Percent Change From Baseline in Triglycerides (TG) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline | Baseline and 64 weeks |
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline | Baseline and 64 weeks |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline | Baseline and 64 weeks |
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline | Baseline and 24 weeks |
| Le NA, Jin R, Tomassini JE, Tershakovec AM, Neff DR, Wilson PW. Changes in lipoprotein particle number with ezetimibe/simvastatin coadministered with extended-release niacin in hyperlipidemic patients. J Am Heart Assoc. 2013 Aug 7;2(4):e000037. doi: 10.1161/JAHA.113.000037. |
| 22338103 | Derived | Guyton JR, Fazio S, Adewale AJ, Jensen E, Tomassini JE, Shah A, Tershakovec AM. Effect of extended-release niacin on new-onset diabetes among hyperlipidemic patients treated with ezetimibe/simvastatin in a randomized controlled trial. Diabetes Care. 2012 Apr;35(4):857-60. doi: 10.2337/dc11-1369. Epub 2012 Feb 14. |
| FG001 | Ezetimibe/Simvastatin | (Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. (Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks. |
| FG002 | Ezetimibe/Simvastatin + Niacin | (Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks. (Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 2 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Niacin | (Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg. |
| BG001 | Ezetimibe/Simvastatin | (Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. (Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks. |
| BG002 | Ezetimibe/Simvastatin + Niacin | (Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks. (Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks. |
| BG003 | 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 | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Body Mass Index | 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-Cholesterol (LDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline | The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol. | Posted | Mean | Standard Error | Percent change | Baseline and 24 Weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline | The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol. | Posted | Mean | Standard Error | Percent change | Baseline and 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline | The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol. | Posted | Mean | Standard Error | Percent change | Baseline and 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Triglycerides (TG) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline | The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol. | Posted | Median | Standard Deviation | Percent change | baseline and 24 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline | The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24. | Posted | Mean | Standard Error | Percent change | Baseline and 64 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Triglycerides (TG) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline | The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24. | Posted | Median | Standard Deviation | Percent change | Baseline and 64 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline | The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24. | Posted | Mean | Standard Error | Percent change | Baseline and 64 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline | The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24. | Posted | Mean | Standard Error | Percent change | Baseline and 64 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline | The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol. | Posted | Mean | Standard Error | Percent change | Baseline and 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline | The analysis population is the modified intention-to-treat population, which includes patients that were randomized to ezetimibe/simvastatin + niacin or ezetimibe/simvastatin treatment groups and have a baseline measurement and at least on measurement beyond Week 24. | Posted | Mean | Standard Error | Percent change | Baseline and 24 weeks |
|
|
Not provided
Not provided
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 | Niacin | Niacin group from Part 1 | 8 | 121 | ||||
| EG001 | Ezetimibe/Simvastatin | Ezetimibe/Simvastatin group from Part 1 | 13 | 428 | ||||
| EG002 | Ezetimibe/Simvastatin + Niacin | Ezetimibe/Simvastatin + Niacin group from Part 1 | 16 | 185 | ||||
| EG003 | Ezetimibe/Simvastatin - Part 2 | EZ/Simva group from Part 2 All-Treated Patient as Treated Population | 29 | 175 | ||||
| EG004 | Ezetimibe/Simvastatin + Niacin - Part 2 | Ezetimibe/Simvastatin + Niacin group from Part 2 All-Treated Patient as Treated Population | 59 | 505 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Aplastic Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Acute Coronary Syndrome | Cardiac disorders | Non-systematic Assessment |
| ||
| Acute Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Angina Pectoris | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac Failure Congestive | Cardiac disorders | Non-systematic Assessment |
| ||
| Coronary Artery Disease | Cardiac disorders | Non-systematic Assessment |
| ||
| Coronary Artery Stenosis | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Spondylolisthesis | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pancreatic Mass | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Chest Pain | General disorders | Non-systematic Assessment |
| ||
| Non-Cardiac Chest Pain | General disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Anaphylactic Reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Abdominal Abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Diverticulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Herpes Zoster Oticus | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Non-systematic Assessment |
| ||
| Perirectal Abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Rocky Mountain Spotted Fever | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Staphylococcal Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Viral Labyrinthitis | Infections and infestations | Non-systematic Assessment |
| ||
| Muscle Strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Ankle Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Cervical Vertebral Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fibula Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Ligament Injury | Infections and infestations | Non-systematic Assessment |
| ||
| Tibia Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Transaminases Abnormal | Investigations | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypovolaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Breast Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Lip Neoplasm Malignant Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Metastases To Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Metastases To Lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Cerebral Infarction | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebrovascular Accident | Nervous system disorders | Non-systematic Assessment |
| ||
| Cervical Cord Compression | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Renal Failure Acute | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Uterine Prolapse | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Deep Vein Thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Thrombosis | Vascular 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 |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis Viral | Infections and infestations | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | 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 |
| ||
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain In Extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Flushing | Vascular disorders | Non-systematic Assessment |
| ||
| Hot Flush | Vascular disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
Part 1 population is all patients enrolled in Part 1 of the study. Part 2 is those patients who received either niacin, ezetimibe/simvastatin, or ezetimibe/simvastatin + niacin during Part 1 until they finished the study at week 64 or discontinued.
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 |
|---|---|
| D019821 | Simvastatin |
| D009525 | Niacin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Lost to Follow-up |
|
| Protocol Violation |
|
| Patient Moved |
|
| Withdrawal by Subject |
|
| LDL < 50 mg/dL |
|
| Male |
|
| Black |
|
| Hispanic |
|
| Other |
|
| White |
|
| 25 to <30 kg/m2 |
|
| 30 to <40 kg/m2 |
|
| ≥ 40 kg/m2 |
|
| No BMI Data |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|