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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_621 |
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The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | laropiprant/niacin (MK0524A) |
|
| 2 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laropiprant/niacin (MK0524A) | Drug | Treatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks | Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks | Percent change from baseline in High Density Lipoprotein Cholesterol (HDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100 | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21291812 | Result | Kush D, Kim HS, Hu DY, Liu J, Sirah W, Sapre A, McCrary Sisk C, Paolini JF, Maccubbin D. Lipid-modifying efficacy of extended release niacin/laropiprant in Asian patients with primary hypercholesterolemia or mixed hyperlipidemia. J Clin Lipidol. 2009 May-Jun;3(3):179-86. doi: 10.1016/j.jacl.2009.04.048. Epub 2009 May 3. |
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Asia-regional lipid study with patients 18-70 yrs, including diabetic patients +/- statin, without ischemic vascular disease and LDL-C<130 mg/dL (3.37 mmol/L), patients on a statin with ≥2 risk factors with LDL-C ≥130 and ≤160 mg/dL (3.37 and 4.14 mmol/L), and patients +/- statin with ≤1 risk factor with ≥130 and ≤190 mg/dL (3.37 and 4.92 mmol/L).
Phase III
First Patient In: 10-May-2007
Last Patient Last Visit: 11-Mar-2008
42 Outpatient centers in China (21), Hong Kong (2), India (11), and Korea (8)
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| ID | Title | Description |
|---|---|---|
| FG000 | MK0524A 2 g | All patients received placebo for a 4 week run-in period before randomization. Drug: laropiprant/niacin (MK0524A) Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks. Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks. |
| FG001 | Placebo | All patients received placebo for a 4 week run-in period before randomization. Drug: Comparator: placebo Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK0524A 2 g | All patients received placebo for a 4 week run-in period before randomization. Drug: laropiprant/niacin (MK0524A) Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks. Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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) After 12 Weeks | Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100 | Full Analysis Set: consisted of all randomized patients who (i) took at least one dose of the treatment period study medication and (ii) had a baseline measurement and at least one measurement during Weeks 5 to 12. The last available lipid values during Weeks 5 to 12 were used for patients who had no lipid data collected at Week 12. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | 12 weeks |
|
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The number of participants at risk for laboratory adverse events represents participants for whom laboratory test results were recorded postbaseline.
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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 | MK0524A 2 g | All patients received placebo for a 4 week run-in period before randomization. Drug: laropiprant/niacin (MK0524A) Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks. Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | 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 |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C518174 | MK-0524 |
| D009525 | Niacin |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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|
|
| Comparator: placebo | Drug | Treatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization. |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Flushing with Product |
|
| Laboratory Adverse Event |
|
| Patient Discontinued for Other Reasons |
|
| Placebo |
All patients received placebo for a 4 week run-in period before randomization. Drug: Comparator: placebo Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Concomitant Statin Use | Number | Participants |
|
| Country | Number | Participants |
|
| Glycemic Status | Fasting Plasma Glucose (FPG) *Glycemic Status (Source: American Diabetes Association Guidelines)
| Number | Participants |
|
| High Density Lipoprotein Cholesterol (HDL-C) | Mean | Standard Deviation | mg/dL |
|
| Low Density Lipoprotein Cholesterol (LDL-C) | Mean | Standard Deviation | mg/dL |
|
| OG001 | Placebo | All patients received placebo for a 4 week run-in period before randomization. Drug: Comparator: placebo Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks. |
|
|
|
| Secondary | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks | Percent change from baseline in High Density Lipoprotein Cholesterol (HDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100 | Full Analysis Set: consisted of all randomized patients who (i) took at least one dose of the treatment period study medication and (ii) had a baseline measurement and at least one measurement during Weeks 5 to 12. The last available lipid values during Weeks 5 to 12 were used for patients who had no lipid data collected at Week 12. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | 12 weeks |
|
|
|
|
| 3 |
| 321 |
| 123 |
| 321 |
| EG001 | Placebo | All patients received placebo for a 4 week run-in period before randomization. Drug: Comparator: placebo Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks. | 2 | 323 | 54 | 323 |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Gastritis Haemorrhagic | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Endocrine disorders | MedDRA 9.1 | Systematic Assessment |
|
| Creatine Phosphokinase Increased | Endocrine disorders | MedDRA 9.1 | Systematic Assessment |
|
| Fasting Blood Glucose Increased | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Protein Urine Present | Renal and urinary disorders | MedDRA 9.1 | 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.
| D006573 |
| Heterocyclic Compounds, 1-Ring |