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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2012/08/002873 | Registry Identifier | CTRI |
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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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The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination tablets in a primary prevention population currently not taking or eligible for lipid-modifying therapy (LMT); the population will comprise participants with low to moderate risk for coronary heart disease (CHD), low high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C) at or below goal level, and normal or mildly elevated triglyceride (TG) levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERN/LRPT group | Experimental | All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive ERN/LRPT for 16 weeks. |
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| Placebo group | Placebo Comparator | All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive placebo for 16 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERN/LRPT | Drug | ERN/LRPT combination tablets (each containing 1 g of extended release niacin and 20 mg of laropiprant), orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16 | The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16. | Baseline and Weeks 12 to 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16 | The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16. | Baseline and Week 16 |
| Percent Change From Baseline in HDL-C at Week 16 |
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Inclusion criteria:
Exclusion criteria:
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This study took place at 37 centers in 2 countries (29 sites in India and 8 sites in Philippines).
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| ID | Title | Description |
|---|---|---|
| FG000 | ERN/LPRT | Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| placebo | Drug | ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks |
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The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16. |
| Baseline and Week 16 |
| Percent Change From Baseline in Triglycerides (TG) at Week 16 | The percentage change from baseline in participants' TG level was to be evaluated at study Week 16. | Baseline and Week 16 |
| Percent Change From Baseline in Non-HDL-C at Week 16 | The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16. | Baseline and Week 16 |
| Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16 | The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16. | Baseline and Week 16 |
| Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16 | The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16. | Baseline and Week 16 |
| Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 | The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16. | Baseline and Week 16 |
| Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16 | The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16. | Baseline and Week 16 |
| Placebo |
Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ERN/LPRT | Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk. |
| BG001 | Placebo | Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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) Averaged Across Week 12 and Week 16 | The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16. | Due to early study termination, this efficacy endpoint was not analyzed. | Posted | Baseline and Weeks 12 to 16 |
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| Secondary | Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16 | The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16. | Due to early study termination, this efficacy endpoint was not analyzed | Posted | Baseline and Week 16 |
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| ||||||||||||||||||||||
| Secondary | Percent Change From Baseline in HDL-C at Week 16 | The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16. | Due to early study termination, this efficacy endpoint was not analyzed. | Posted | Baseline and Week 16 |
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| Secondary | Percent Change From Baseline in Triglycerides (TG) at Week 16 | The percentage change from baseline in participants' TG level was to be evaluated at study Week 16. | Due to early study termination, this efficacy endpoint was not analyzed. | Posted | Baseline and Week 16 |
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| Secondary | Percent Change From Baseline in Non-HDL-C at Week 16 | The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16. | Due to early study termination, this efficacy endpoint was not analyzed. | Posted | Baseline and Week 16 |
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| Secondary | Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16 | The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16. | Due to early study termination, this efficacy endpoint was not analyzed. | Posted | Baseline and Week 16 |
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| Secondary | Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16 | The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16. | Due to early study termination, this efficacy endpoint was not analyzed. | Posted | Baseline and Week 16 |
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| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 | The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16. | Due to early study termination, this efficacy endpoint was not analyzed. | Posted | Baseline and Week 16 |
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| Secondary | Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16 | The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16. | Due to early study termination, this efficacy endpoint was not analyzed. | Posted | Baseline and Week 16 |
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Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.
The safety population consisted of all participants that received at least one dose of study drug.
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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 | ERN/LPRT | Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk. | 1 | 120 | 42 | 120 | ||
| EG001 | Placebo | Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk. | 0 | 121 | 17 | 121 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Impaired Fasting Glucose | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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Due to the small number of participants completing the study (n=70), the resulting underpowered nature of any analyses that might be conducted, and the fact that data are not going to be used, no efficacy analyses were performed.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Male |
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