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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023939-42 | EudraCT Number |
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This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets (ERN/LRPT + SIM) for lowering high cholesterol and high lipid levels in the blood. The primary hypothesis is that ERN/LRPT/SIM 2 g/40 mg is equivalent to ERN/LRPT 2 g co-administered with simvastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg | Experimental | After a 2-week placebo run-in, participants received extended release (ER) niacin/laropiprant (N/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. |
|
| Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g | Experimental | After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded. Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated. | Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded. Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated. |
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Inclusion criteria
Exclusion Criteria
Participant is pregnant or breast-feeding, or expecting to conceive during the study.
Participant has a history of malignancy.
Participant consumes more than 3 alcoholic drinks per day (14 per week).
Participant is high risk CHD patient on statin therapy or any patient on statin therapy equivalent to 80 mg simvastatin.
Participant with Type 1 or Type 2 diabetes mellitus that is poorly controlled, or on statin therapy.
Participant currently engages in vigorous exercise or is on an aggressive diet regimen.
Participant uncontrolled endocrine or metabolic disease, uncontrolled gout, kidney or hepatic disease, heart failure, recent peptic ulcer disease, hypersensitivity or allergic reaction to niacin or simvastatin, recent heart attack, stroke or heart surgery.
Participant is human immunodeficiency virus (HIV) positive.
Participant has taken niacin >50 mg/day, bile-acid sequestrants, hydroxymethyl glutaryl coenzyme A (HMG-CoA) reductase inhibitors, ezetimibe, Cholestinâ„¢ [red yeast rice] and other red yeast products within 6 weeks, or fibrates within 8 weeks of randomization visit (Visit 3).
Participant is currently receiving cyclical hormonal contraceptives or intermittent use of hormone replacement therapies (HRTs) (e.g., estradiol, medroxyprogesterone, progesterone).
Participant is taking prohibited medications such as systemic corticosteroids, itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, HIV protease inhibitors, verapamil, amiodarone, cyclosporine, danazol, diltiazem or fusidic acid.
Participant consumes >1 quart of grapefruit juice/day.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis Link | View IPD |
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Participants completed a 6-8 week washout then completed a 2-week placebo run-in prior to the start of active treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg | After a 2-week placebo run-in, participants received extended release niacin/laropiprant (ERN/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Precrossover (Periods I/II) |
|
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| Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM) | Drug |
|
|
| Extended Release (ER) niacin/laropiprant (N/LRPT) | Drug |
|
|
| Placebo | Drug |
|
| Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III) |
| Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN) | Participants had AST and ALT levels assessed during Period I (4 weeks ) and throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively. | Up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN | Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively. | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN | Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively. | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| Percentage of Participants With Creatine Kinase (CK) >=10 x ULN | Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was >=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively. | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related | Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively. | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| Percentage of Participants Who Experienced at Least 1 Hepatitis-related Adverse Event (AE) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, 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 product, was also an AE. Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury. | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| Percentage of Participants With New Onset of Diabetes | Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an AE related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults. | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event | Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee a cardiovascular events were recorded. | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| Percentage of Participants Who Experienced at Least 1 AE | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, 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 product, was also an AE. | up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III) |
| Percentage of Participants Who Were Discontinued From the Study Due to an AE | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, 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 product, was also an AE. Participants who were discontinued from the study due to an AE were recorded. | up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III) |
| FG001 | Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g | After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks. |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Post Crossover (Period III) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg | After a 2-week placebo run-in, participants received extended release niacin/laropiprant (ERN/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. |
| BG001 | Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g | After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks. |
| BG002 | 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 |
|
| 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 | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded. Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated. | Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed. | Posted | Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) |
|
| ||||||||||||||||||||||
| Secondary | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) | Blood samples were taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment (Week 12 for Period II and Week 20 for Period III) to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded. Results from recent studies indicated that the combination tablet formulations used in the study did not meet the pre-specified pharmacokinetic bounds used to establish the equivalence of the combination tablet (MK-0524B; ERN/LRPT/SIM) to the coadministration of MK-0524A (ERN/LRPT) and SIM. Therefore, efficacy data were not analyzed, as the study was stopped early. Only safety data were evaluated. | Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed. | Posted | Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III) |
| |||||||||||||||||||||||
| Secondary | Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN) | Participants had AST and ALT levels assessed during Period I (4 weeks ) and throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively. | All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III. | Posted | Number | Percentage of Participants | Up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| |||||||||||||||||||||
| Secondary | Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN | Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively. | All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III. | Posted | Number | Percentage of Participants | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| |||||||||||||||||||||
| Secondary | Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN | Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively. | All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III. | Posted | Number | Percentage of Participants | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| |||||||||||||||||||||
| Secondary | Percentage of Participants With Creatine Kinase (CK) >=10 x ULN | Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was >=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively. | All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III. | Posted | Number | Percentage of Participants | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| |||||||||||||||||||||
| Secondary | Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related | Participants had CK levels assessed throughout the treatment periods. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively. | All randomized participants who received at least 1 dose of study drug and had at least 1 postbaseline measurement within 14 days of the last dose of study drug. Analysis was based on the experiences accumulated during Periods I/II combined, where the study followed a parallel design. A separate safety analysis was performed for Period III. | Posted | Number | Percentage of Participants | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| |||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced at Least 1 Hepatitis-related Adverse Event (AE) | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, 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 product, was also an AE. Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury. | All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Posted | Number | Percentage of Participants | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| |||||||||||||||||||||
| Secondary | Percentage of Participants With New Onset of Diabetes | Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an AE related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults. | All participants without diabetes at baseline and who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Posted | Number | Percentage of Participants | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| |||||||||||||||||||||
| Secondary | Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event | Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee a cardiovascular events were recorded. | All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Posted | Number | Percentage of Participants | up 20 weeks (12 weeks in Periods I/II and 8 weeks in Period III) |
| |||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced at Least 1 AE | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, 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 product, was also an AE. | All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Posted | Number | Percentage of Participants | up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III) |
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| Secondary | Percentage of Participants Who Were Discontinued From the Study Due to an AE | An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, 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 product, was also an AE. Participants who were discontinued from the study due to an AE were recorded. | All participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study followed a parallel design. A separate safety analysis was performed for Period III (post-crossover). | Posted | Number | Percentage of Participants | up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III) |
|
up 22 weeks (12 weeks in Periods I/II and 10 weeks in Period III)
Population included all participants who received at least 1 dose of study drug. Safety analysis was based on the experiences accumulated during Periods I/II combined (pre-crossover), where the study follows a parallel design. A separate safety analysis was performed for Period III (post-crossover).
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 | Sequence 1: MK-0524B 2g/40g | Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II | 6 | 486 | 110 | 486 | ||
| EG001 | Sequence 2: MK-0524A 2g + Simvastatin 40 mg | Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II | 9 | 486 | 98 | 486 | ||
| EG002 | Sequence 1: MK-0524A 2g + Simvastatin 40 mg | Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III | 1 | 230 | 0 | 230 | ||
| EG003 | Sequence 2: MK-0524B 2g/40g | Participants who received MK-0524B 2g/40mg during Period III | 5 | 220 | 0 | 220 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
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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. Sponsor review can be expedited to meet publication timelines.
| 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 |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
Not provided
Not provided
| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D009525 | Niacin |
| C518174 | MK-0524 |
| 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 |
Not provided
Not provided
| Study Terminated by Sponsor |
|
| Withdrawal by Subject |
|
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
| Sequence 1: MK-0524A 2g + Simvastatin 40 mg |
Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III. |
| OG003 | Sequence 2: MK-0524B 2g/40g | Participants who received MK-0524B 2g/40mg during Period III |
|
|
|
Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III. |
| OG003 | Sequence 2: MK-0524B 2g/40g | Participants who received MK-0524B 2g/40mg during Period III |
|
|
|
Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III. |
| OG003 | Sequence 2: MK-0524B 2g/40g | Participants who received MK-0524B 2g/40mg during Period III |
|
|
| OG003 | Sequence 2: MK-0524B 2g/40g | Participants who received MK-0524B 2g/40mg during Period III |
|
|
|
Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
| OG003 | Sequence 2: MK-0524B 2g/40g | Participants who received MK-0524B 2g/40mg during Period III |
|
|
| Sequence 2: MK-0524A 2g + Simvastatin 40 mg |
Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II. |
| OG002 | Sequence 1: MK-0524A 2g + Simvastatin 40 mg | Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III. |
| OG003 | Sequence 2: MK-0524B 2g/40g | Participants who received MK-0524B 2g/40mg during Period III |
|
|
| OG002 | Sequence 1: MK-0524A 2g + Simvastatin 40 mg | Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III. |
| OG003 | Sequence 2: MK-0524B 2g/40g | Participants who received MK-0524B 2g/40mg during Period III |
|
|
|
| OG003 | Sequence 2: MK-0524B 2g/40g | Participants who received MK-0524B 2g/40mg during Period III |
|
|
|
Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
| OG003 | Sequence 2: MK-0524B 2g/40g | Participants who received MK-0524B 2g/40mg during Period III |
|
|
|
Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III. |
| OG003 | Sequence 2: MK-0524B 2g/40g | Participants who received MK-0524B 2g/40mg during Period III |
|
|
|