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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_011 | Other Identifier | Merck Study Number |
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The aim of this observational program is to generate data on the use of Tredaptive (nicotinic acid/laropiprant) for lipid management under routine medical practice conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated within a disease management program | Participant prescribed Tredaptive® for dyslipidemia and also participated in a disease management program for treatment of diabetes mellitus, coronary heart disease or both. | ||
| Patients treated outside a disease management program | Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Lipid Panel Control | Lipid Panel Control was defined as achieving target for one or more of the following parameters: low-density lipoprotein cholesterol (LDL-C) at goal (<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL). | From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Reported Adverse Events | Up to 22 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in routine medical care either statutorily health insured or privately insured
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Evaluable Participants | Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intent-to-Treat Population | Baseline characteristics were reported for the 2359 participants in the Intent-to-Treat (ITT) Population, which included all participants from the Evaluable Population who began therapy at or after Visit 1. The ITT Population excluded 31 of the 2390 evaluable participants who began treatment prior to Visit 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data was missing 13 of the 2359 participants in the ITT Population. |
| 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 | Number of Participants With Lipid Panel Control | Lipid Panel Control was defined as achieving target for one or more of the following parameters: low-density lipoprotein cholesterol (LDL-C) at goal (<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL). | Results are for the Intent-to-Treat (ITT) Population. Information regarding the participation in a disease management program was not reported for 63 participants in the ITT Population. | Posted | Number | participants | From Visit 1 entrance evaluation (Week 0) to Visit 2 (between Weeks 8-22) |
|
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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 | All Evaluable Participants | Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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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 |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Mean |
| Full Range |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Patients Treated Outside a Disease Management Program | Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both. |
|
|
| Secondary | Number of Participants Who Reported Adverse Events | Posted | Number | participants | Up to 22 weeks |
|
|
|
| 20 |
| 2,390 |
| 0 |
| 2,390 |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Coronary Artery Insufficiency | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lip Swelling | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pancreatic Cyst | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pancreatitis Chronic | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Feeling Hot | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Splenic Abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Blood Cholesterol Abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood Triglycerides Abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood Triglycerides Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Lipoprotein (A) Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lipid Metabolism Disorder | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Multiple Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pruritus Generalised | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Swelling Face | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Appendicectomy | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| Pain Management | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
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| Skin Swelling | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
MSD SHARP & DOHME GmbH and its comarketing companies have exclusive rights to the use and evaluation of the data collected in this study.
| Cardiovascular Disorder |
|
| Coronary Artery Insufficiency |
|
| Tachycardia |
|
| Eyelid Oedema |
|
| Visual Impairment |
|
| Abdominal Discomfort |
|
| Abdominal Distension |
|
| Abdominal Pain |
|
| Abdominal Pain Upper |
|
| Constipation |
|
| Diarrhoea |
|
| Dyspepsia |
|
| Eructation |
|
| Flatulence |
|
| Gastrointestinal Disorder |
|
| Irritable Bowel Syndrome |
|
| Lip Swelling |
|
| Nausea |
|
| Pancreatic Cyst |
|
| Pancreatitis Chronic |
|
| Vomiting |
|
| Adverse Event |
|
| Asthenia |
|
| Chills |
|
| Condition Aggravated |
|
| Drug Ineffective |
|
| Drug Intolerance |
|
| Face Oedema |
|
| Fatigue |
|
| Feeling Abnormal |
|
| Feeling Hot |
|
| Hyperthermia |
|
| Malaise |
|
| Oedema |
|
| Oedema Peripheral |
|
| Pain |
|
| Swelling |
|
| Cholelithiasis |
|
| Hypersensitivity |
|
| Diverticulitis |
|
| Gastroenteritis |
|
| Rash Pustular |
|
| Splenic Abscess |
|
| Accident |
|
| Alanine Aminotransferase Increased |
|
| Blood Cholesterol Abnormal |
|
| Blood Cholesterol Increased |
|
| Blood Creatine Phosphokinase Increased |
|
| Blood Creatinine Increased |
|
| Blood Glucose Abnormal |
|
| Blood Glucose Fluctuation |
|
| Blood Glucose Increased |
|
| Blood Pressure Decreased |
|
| Blood Triglycerides Abnormal |
|
| Blood Triglycerides Increased |
|
| Blood Uric Acid Increased |
|
| Gamma-Glutamyltransferase Increased |
|
| Lipids Abnormal |
|
| Lipids Increased |
|
| Lipoprotein (A) Increased |
|
| Weight Increased |
|
| Diabetes Mellitus |
|
| Diabetes Mellitus Inadequate Control |
|
| Gout |
|
| Hyperglycaemia |
|
| Lactose Intolerance |
|
| Lipid Metabolism Disorder |
|
| Arthralgia |
|
| Muscular Weakness |
|
| Musculoskeletal Discomfort |
|
| Musculoskeletal Stiffness |
|
| Myalgia |
|
| Pain In Extremity |
|
| Spondylitis |
|
| Multiple Myeloma |
|
| Burning Sensation |
|
| Dizziness |
|
| Dysaesthesia |
|
| Headache |
|
| Hypotonia |
|
| Paraesthesia |
|
| Anxiety |
|
| Depressed Mood |
|
| Depression |
|
| Fear |
|
| Insomnia |
|
| Loss of Libido |
|
| Restlessness |
|
| Sleep Disorder |
|
| Asthma |
|
| Dyspnoea |
|
| Increased Upper Airway Secretion |
|
| Cold Sweat |
|
| Dermatitis Allergic |
|
| Eczema |
|
| Erythema |
|
| Hyperhidrosis |
|
| Petechiae |
|
| Pruritus |
|
| Pruritus Generalised |
|
| Rash |
|
| Skin Burning Sensation |
|
| Skin Disorder |
|
| Skin Reaction |
|
| Skin Swelling |
|
| Swelling Face |
|
| Urticaria |
|
| Appendicectomy |
|
| Pain Management |
|
| Vascular Graft |
|
| Flushing |
|
| Hot Flush |
|
| Hypertension |
|