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In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs
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This survey is being conducted to assess the safety and efficacy of niacin (+) laropiprant (TREDAPTIVE) in usual practice in Korea according to the new product re-examination regulations of the Korean Food and Drug Administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niacin (+) laropiprant | Drug | Niacin (+) laropiprant (TREDAPTIVE) prescribed according to the current local label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Any Adverse Experience | An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event. | From start of treatment through 14 days after the last dose (Up to 26 weeks) |
| Percentage of Participants With Adverse Drug Reactions | An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event. | From start of treatment through 14 days after the last dose (Up to 26 weeks) |
| Change From Baseline in Total Cholesterol at Week 12 | Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE | Baseline and Week 12 |
| Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE | Baseline and Week 12 |
| Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Korean participants with hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) for the first time
A completer was considered a participant eligible for safety population. Efficacy population was a sub-population of the safety population
1,166 participants who were currently using niacin (+) laropiprant (TREDAPTIVE) for treatment of primary hypercholesterolemia or mixed dyslipidemia were enrolled and their case report forms were collected. Enrollment was stopped early due to termination of all studies involving TREDAPTIVE.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics presented for participants in the Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Any Adverse Experience | An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event. | Safety population: all enrolled participants who met entry criteria regarding safety data | Posted | Number | Percentage of participants | From start of treatment through 14 days after the last dose (Up to 26 weeks) |
|
From start of treatment through 14 days after the last dose (Up to 26 weeks)
Safety population: all enrolled participants who met entry criteria regarding safety data
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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 PARTICIPANTS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
Study enrollment stopped early due to termination of all TREDAPTIVE studies. Data obtained for participants enrolled prior to termination was analyzed and reported.
| 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 |
|---|---|
| D009525 | Niacin |
| C518174 | MK-0524 |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE
| Baseline and Week 12 |
| Change From Baseline in Triglycerides at Week 12 | Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE | Baseline and Week 12 |
| Change From Baseline in Total Cholesterol at Week 24 | Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE | Baseline and Week 24 |
| Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 | Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE | Baseline and Week 24 |
| Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 | Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE | Baseline and Week 24 |
| Change From Baseline in Triglycerides at Week 24 | Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE | Baseline and Week 24 |
| Investigator's Overall Efficacy Evaluation at Week 12 | The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of "Improved", "Unchanged" or "Worsened" when compared to baseline. | Baseline and Week 12 |
| Investigator's Overall Efficacy Evaluation at Week 24 | The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of "Improved", "Unchanged" or "Worsened" when compared to baseline. | Baseline and Week 24 |
| Triglyceride Entry Criteria Not Met |
|
| Violation of Entry Criterion |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Participants With Adverse Drug Reactions | An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the study drug, was also an adverse event. | Safety population: all enrolled participants who met entry criteria regarding safety data | Posted | Number | Percentage of Participants | From start of treatment through 14 days after the last dose (Up to 26 weeks) |
|
|
|
| Primary | Change From Baseline in Total Cholesterol at Week 12 | Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE | Participants in safety population whose case report form contained baseline and Week 12 data for total cholesterol levels. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12 |
|
|
|
| Primary | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE | Participants in safety population whose case report form contained baseline and Week 12 data for LDL-C levels. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12 |
|
|
|
| Primary | Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE | Participants in safety population whose case report form contained baseline and Week 12 data for HDL-C levels. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12 |
|
|
|
| Primary | Change From Baseline in Triglycerides at Week 12 | Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE | Participants in safety population whose case report form contained baseline and Week 12 data for triglyceride levels. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 12 |
|
|
|
| Primary | Change From Baseline in Total Cholesterol at Week 24 | Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE | Participants in safety population whose case report form contained baseline and Week 24 data for total cholesterol levels and had received TREDAPTIVE for 24 weeks | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
|
|
|
| Primary | Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 | Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE | Participants in safety population whose case report form contained baseline and Week 24 data for LDL-C levels and had received TREDAPTIVE for 24 weeks | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
|
|
|
| Primary | Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 | Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE | Participants in safety population whose case report form contained baseline and Week 24 data for HDL-C levels and had received TREDAPTIVE for 24 weeks | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
|
|
|
| Primary | Change From Baseline in Triglycerides at Week 24 | Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE | Participants in safety population whose case report form contained baseline and Week 24 data for triglyceride levels and had received TREDAPTIVE for 24 weeks | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
|
|
|
| Primary | Investigator's Overall Efficacy Evaluation at Week 12 | The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of "Improved", "Unchanged" or "Worsened" when compared to baseline. | Participants in safety population whose case report form contained the investigator's overall assessment after 12 weeks of treatment with TREDAPTIVE | Posted | Number | Percentage of Participants | Baseline and Week 12 |
|
|
|
| Primary | Investigator's Overall Efficacy Evaluation at Week 24 | The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of "Improved", "Unchanged" or "Worsened" when compared to baseline. | Participants in safety population whose case report form contained the investigator's overall assessment after 24 weeks of treatment with TREDAPTIVE | Posted | Number | Percentage of Participants | Baseline and Week 24 |
|
|
|
| 7 |
| 862 |
| 65 |
| 862 |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA 16.0 | Systematic Assessment |
|
| UPPER EXTREMITY MASS | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| COMMUNICATION DISORDER | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
|
Any publication must be approved by the Sponsor.
| D009750 |
| Nutritional and Metabolic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|