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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0524B-024 | Other Identifier | Merck Study Number | |
| 2005_103 |
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This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to atorvastatin on decreasing the low denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg MK-0524B versus 80 mg atorvastatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-0524B 2g/20 mg | Experimental | Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks |
|
| MK-0524B 2g/40mg | Experimental | Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks |
|
| Atorvastatin 10 mg | Active Comparator | Atorvastatin 10 mg, orally, once daily for 12 weeks |
|
| Atorvastatin 20 mg | Active Comparator | Atorvastatin 20 mg, orally, once daily for 12 weeks |
|
| Atorvastatin 40 mg | Active Comparator | Atorvastatin 40 mg, orally, once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0524A | Drug |
| ||
| Atorvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in the LDL-C/HDL-C Ratio | Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in HDL-C | Blood samples taken at baseline and after 12 weeks of treatment to determine the HDL-C levels. The change from baseline at Week 12 was recorded. | Baseline and Week 12 |
| Percentage Change From Baseline in Triglycerides (TG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22305632 | Result | Chen F, Maccubbin D, Yan L, Sirah W, Chen E, Sisk CM, Davidson M, Blomqvist P, McKenney JM. Lipid-altering efficacy and safety profile of co-administered extended release niacin/laropiprant and simvastatin versus atorvastatin in patients with mixed hyperlipidemia. Int J Cardiol. 2013 Jul 15;167(1):225-31. doi: 10.1016/j.ijcard.2011.12.103. Epub 2012 Feb 4. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis Link | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-0524B 2g/20 mg | Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks |
| FG001 | MK-0524B 2g/40mg | Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks |
| FG002 | Atorvastatin 10 mg | Atorvastatin 10 mg, orally, once daily for 12 weeks |
| FG003 | Atorvastatin 20 mg | Atorvastatin 20 mg, orally, once daily for 12 weeks |
| FG004 | Atorvastatin 40 mg | Atorvastatin 40 mg, orally, once daily for 12 weeks |
| FG005 | Atorvastatin 80 mg | Atorvastatin 80 mg, orally, once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-0524B 2g/20 mg | Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks |
| BG001 | MK-0524B 2g/40mg |
| 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 Change From Baseline in the LDL-C/HDL-C Ratio | Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded. | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline and Week 12 |
|
up to 14 weeks
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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 | MK-0524B 2g/20 mg | Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | 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 |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Atorvastatin 80 mg |
| Active Comparator |
Atorvastatin 80 mg, orally, once daily for 12 weeks |
|
| Drug |
|
|
| Simvastatin | Drug |
|
|
Blood samples taken at baseline and after 12 weeks of treatment to determine the TG levels. The change from baseline at Week 12 was recorded. |
| Baseline and Week 12 |
| Percentage Change From Baseline in Non-HDL-C | Blood samples taken at baseline and after 12 weeks of treatment to determine the non-HDL-C levels. The change from baseline at Week 12 was recorded. | Baseline and Week 12 |
| Percentage Change From Baseline in LDL-C | Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C levels. The change from baseline at Week 12 was recorded. | Baseline and Week 12 |
| Percentage Change From Baseline in Apolipoprotein (Apo) B | Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo B levels. The change from baseline at Week 12 was recorded. | Baseline and Week 12 |
| Percentage Change From Baseline in Apo A-I | Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo A-I levels. The change from baseline at Week 12 was recorded. | Baseline and Week 12 |
| Percentage Change From Baseline in Total Cholesterol (TC) | Blood samples taken at baseline and after 12 weeks of treatment to determine the TC levels. The change from baseline at Week 12 was recorded. | Baseline and Week 12 |
| Percentage Change From Baseline in Lipoprotein (a) (Lp[a]) | Blood samples taken at baseline and after 12 weeks of treatment to determine the Lp(a) levels. The change from baseline at Week 12 was recorded. | Baseline and Week 12 |
| Percentage Change From Baseline in C-reactive Protein (CRP) | Blood samples taken at baseline and after 12 weeks of treatment to determine the CRP levels. The change from baseline at Week 12 was recorded. | Baseline and Week 12 |
| Percentage Change From Baseline in TC/HDL-C Ratio | Blood samples taken at baseline and after 12 weeks of treatment to determine the TC and HDL-C levels. The TC/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded. | Baseline and Week 12 |
| 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 throughout the 12 week treatment period. Participants who had 2 consecutive assessments of either AST or ALT that were 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 to 12 weeks |
| Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN | Participants had AST and ALT levels assessed throughout the 12 week treatment period. 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 to 12 weeks |
| Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN | Participants had AST and ALT levels assessed throughout the 12 week treatment period. 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 to 12 weeks |
| Percentage of Participants With Creatine Kinase (CK) >=10 x ULN | Participants had CK assessed throughout the 12 week treatment period. 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 to 12 weeks |
| Percentage of Participants With CK >=10 x ULN With Muscle Symptoms | Participants had CK assessed throughout the 24 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively. | up to 12 weeks |
| Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related | Participants had CK assessed throughout the 12 week treatment period. 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 to 12 weeks |
| Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose | Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became 'impaired' during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome. | up to 12 weeks |
| Percentage of Participants With New Diagnosis of Diabetes | Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (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 to 12 weeks |
| 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 to 14 weeks |
| Percentage of Participants Who Experience at Least 1 Clinical 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. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. | up to 14 weeks |
| Percentage of Participants Who Experience at Least 1 Laboratory 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. A laboratory AE was an AE reported as a result of a laboratory assessment or test. | up to 14 weeks |
| Percentage of Participants Who Were Discontinued From the Study Due to a Clinical 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. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded. | up to 14 weeks |
| Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory 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. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded. | up to 14 weeks |
| Percentage of Participants Who Experience at Least 1 Hepatitis-related Clinical 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 to 14 weeks |
| Lost to Follow-up |
|
| Participant had flushing |
|
| Other |
|
| Participant moved |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| site terminated |
|
| Not treated |
|
Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks |
| BG002 | Atorvastatin 10 mg | Atorvastatin 10 mg, orally, once daily for 12 weeks |
| BG003 | Atorvastatin 20 mg | Atorvastatin 20 mg, orally, once daily for 12 weeks |
| BG004 | Atorvastatin 40 mg | Atorvastatin 40 mg, orally, once daily for 12 weeks |
| BG005 | Atorvastatin 80 mg | Atorvastatin 80 mg, orally, once daily for 12 weeks |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | MK-0524B 2g/40mg | Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks |
| OG002 | Atorvastatin 10 mg | Atorvastatin 10 mg, orally, once daily for 12 weeks |
| OG003 | Atorvastatin 20 mg | Atorvastatin 20 mg, orally, once daily for 12 weeks |
| OG004 | Atorvastatin 40 mg | Atorvastatin 40 mg, orally, once daily for 12 weeks |
| OG005 | Atorvastatin 80 mg | Atorvastatin 80 mg, orally, once daily for 12 weeks |
|
|
|
| Secondary | Percentage Change From Baseline in HDL-C | Blood samples taken at baseline and after 12 weeks of treatment to determine the HDL-C levels. The change from baseline at Week 12 was recorded. | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Week 12 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Triglycerides (TG) | Blood samples taken at baseline and after 12 weeks of treatment to determine the TG levels. The change from baseline at Week 12 was recorded. | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Posted | Median | 95% Confidence Interval | Percentage change | Baseline and Week 12 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Non-HDL-C | Blood samples taken at baseline and after 12 weeks of treatment to determine the non-HDL-C levels. The change from baseline at Week 12 was recorded. | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Week 12 |
|
|
|
|
| Secondary | Percentage Change From Baseline in LDL-C | Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C levels. The change from baseline at Week 12 was recorded. | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Week 12 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Apolipoprotein (Apo) B | Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo B levels. The change from baseline at Week 12 was recorded. | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Week 12 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Apo A-I | Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo A-I levels. The change from baseline at Week 12 was recorded. | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Week 12 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Total Cholesterol (TC) | Blood samples taken at baseline and after 12 weeks of treatment to determine the TC levels. The change from baseline at Week 12 was recorded. | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Week 12 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Lipoprotein (a) (Lp[a]) | Blood samples taken at baseline and after 12 weeks of treatment to determine the Lp(a) levels. The change from baseline at Week 12 was recorded. | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Posted | Median | 95% Confidence Interval | Percentage change | Baseline and Week 12 |
|
|
|
|
| Secondary | Percentage Change From Baseline in C-reactive Protein (CRP) | Blood samples taken at baseline and after 12 weeks of treatment to determine the CRP levels. The change from baseline at Week 12 was recorded. | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Posted | Median | 95% Confidence Interval | Percentage change | Baseline and Week 12 |
|
|
|
|
| Secondary | Percentage Change From Baseline in TC/HDL-C Ratio | Blood samples taken at baseline and after 12 weeks of treatment to determine the TC and HDL-C levels. The TC/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded. | All randomized participants who had taken at least 1 dose of post-randomization study medication and had a baseline value and at least one post-titration measurement for the endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change | Baseline and Week 12 |
|
|
|
|
| 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 throughout the 12 week treatment period. Participants who had 2 consecutive assessments of either AST or ALT that were 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 participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
|
| Secondary | Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN | Participants had AST and ALT levels assessed throughout the 12 week treatment period. 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 participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
|
| Secondary | Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN | Participants had AST and ALT levels assessed throughout the 12 week treatment period. 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 participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
|
| Secondary | Percentage of Participants With Creatine Kinase (CK) >=10 x ULN | Participants had CK assessed throughout the 12 week treatment period. 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 participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
|
| Secondary | Percentage of Participants With CK >=10 x ULN With Muscle Symptoms | Participants had CK assessed throughout the 24 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively. | All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
|
| Secondary | Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related | Participants had CK assessed throughout the 12 week treatment period. 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 participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
|
| Secondary | Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose | Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became 'impaired' during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome. | All participants who had taken at least 1 dose of study medication and normal glycemic status at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
|
| Secondary | Percentage of Participants With New Diagnosis of Diabetes | Participants had blood glucose levels assessed throughout the 12 week treatment period. Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (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 who had taken at least 1 dose of study medication and did not have diabetes at baseline. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 12 weeks |
|
|
|
|
| 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 had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 14 weeks |
|
|
|
|
| Secondary | Percentage of Participants Who Experience at Least 1 Clinical 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. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. | All participants who had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 14 weeks |
|
|
|
|
| Secondary | Percentage of Participants Who Experience at Least 1 Laboratory 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. A laboratory AE was an AE reported as a result of a laboratory assessment or test. | All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 14 weeks |
|
|
|
|
| Secondary | Percentage of Participants Who Were Discontinued From the Study Due to a Clinical 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. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded. | All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 14 weeks |
|
|
|
|
| Secondary | Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory 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. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded. | All participants who had taken at least 1 dose of study medication and had data available for endpoint. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 14 weeks |
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|
|
| Secondary | Percentage of Participants Who Experience at Least 1 Hepatitis-related Clinical 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 had taken at least 1 dose of study medication. Results for participants who received either MK-0524B 2g/20mg or 2g/40 mg were pooled. Results for participants who received atorvastatin 10, 20, 40, or 80 mg were pooled. | Posted | Number | Percentage of Participants | up to 14 weeks |
|
|
|
|
| 3 |
| 297 |
| 71 |
| 297 |
| EG001 | MK-0524B 2g/40 mg | Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks | 8 | 435 | 136 | 435 |
| EG002 | Atorvastatin 10 mg | Atorvastatin 10 mg, orally, once daily for 12 weeks | 3 | 298 | 25 | 298 |
| EG003 | Atorvastatin 20 mg | Atorvastatin 20 mg, orally, once daily for 12 weeks | 5 | 439 | 27 | 439 |
| EG004 | Atorvastatin 40 mg | Atorvastatin 40 mg, orally, once daily for 12 weeks | 3 | 437 | 31 | 437 |
| EG005 | Atorvastatin 80 mg | Atorvastatin 80 mg, orally, once daily for 12 weeks | 7 | 433 | 35 | 433 |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Angle closure glaucoma | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Device malfunction | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abscess oral | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
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 guidelines.
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate |
| <0.001 |
| Difference in Least Squares Mean |
| 21.3 |
| 2-Sided |
| 95 |
| 19.0 |
| 23.6 |
| Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Difference in Least Squares Mean | 22.1 | 2-Sided | 95 | 19.8 | 24.4 | Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Difference in Least Squares Mean | 23.0 | 2-Sided | 95 | 20.7 | 25.3 | Superiority or Other |
|
| Non-parametric ANOVA |
Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate |
| <0.001 |
| Median Difference (Final Values) |
| -15.5 |
| 2-Sided |
| 95 |
| -19.1 |
| -11.9 |
Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test |
| Superiority or Other |
| Non-parametric ANOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Median Difference (Final Values) | -10.3 | 2-Sided | 95 | -13.7 | -7.0 | Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test | Superiority or Other |
| Non-parametric ANOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Median Difference (Final Values) | -6.8 | 2-Sided | 95 | -10.2 | -3.4 | Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test | Superiority or Other |
| ANCOVA |
Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate |
| <0.001 |
| Difference in Least Squares Mean |
| -5.4 |
| 2-Sided |
| 95 |
| -8.0 |
| -2.9 |
| Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | 0.771 | Difference in Least Squares Mean | 0.4 | 2-Sided | 95 | -2.2 | 2.9 | Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | 0.065 | Difference in Least Squares Mean | 2.4 | 2-Sided | 95 | -0.2 | 5.0 | Superiority or Other |
| ANCOVA |
Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate |
| 0.037 |
| Difference in Least Squares Mean |
| -3.0 |
| 2-Sided |
| 95 |
| -5.8 |
| -0.2 |
| Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | 0.047 | Difference in Least Squares Mean | 2.8 | 2-Sided | 95 | 0.0 | 5.6 | Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Difference in Least Sqaures Mean | 4.7 | 2-Sided | 95 | 2.0 | 7.5 | Superiority or Other |
| ANCOVA |
Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate |
| <0.001 |
| Difference in Least Squares Mean |
| -5.2 |
| 2-Sided |
| 95 |
| -7.7 |
| -2.8 |
| Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | 0.476 | Difference in Least Squares Mean | -0.9 | 2-Sided | 95 | -3.3 | 1.5 | Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | 0.845 | Difference in Least Squares Mean | 0.2 | 2-Sided | 95 | -2.2 | 2.7 | Superiority or Other |
Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate |
| <0.001 |
| Difference in Least Squares Mean |
| 7.7 |
| 2-Sided |
| 95 |
| 5.8 |
| 9.7 |
| Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Difference in Least Squares Mean | 9.0 | 2-Sided | 95 | 7.0 | 10.9 | Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Difference in Least Squares Mean | 10.7 | 2-Sided | 95 | 8.7 | 12.7 | Superiority or Other |
Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate |
| 0.595 |
| Difference in Least Squares Mean |
| -0.5 |
| 2-Sided |
| 95 |
| -2.5 |
| 1.5 |
| Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Difference in Least Squares Mean | 4.2 | 2-Sided | 95 | 2.2 | 6.2 | Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Difference in Least Squares Mean | 6.1 | 2-Sided | 95 | 4.1 | 8.1 | Superiority or Other |
|
| Non-parametric ANOVA |
Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate |
| <0.001 |
| Median Difference (Final Values) |
| -20.5 |
| 2-Sided |
| 95 |
| -25.0 |
| -16.6 |
Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test |
| Superiority or Other |
| Non-parametric ANOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Median Difference (Final Values) | -23.9 | 2-Sided | 95 | -27.8 | -19.4 | Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test | Superiority or Other |
| Non-parametric ANOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Median Difference (Final Values) | -24.6 | 2-Sided | 95 | -28.6 | -20.0 | Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test | Superiority or Other |
|
| Non-parametric ANOVA |
Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate |
| 0.083 |
| Median Difference (Final Values) |
| 6.9 |
| 2-Sided |
| 95 |
| 0.0 |
| 13.8 |
Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test |
| Superiority or Other |
| Non-parametric ANOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | 0.005 | Median Difference (Final Values) | 11.9 | 2-Sided | 95 | 5.2 | 18.8 | Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test | Superiority or Other |
| Non-parametric ANOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Median Difference (Final Values) | 16.4 | 2-Sided | 95 | 9.8 | 22.8 | Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test | Superiority or Other |
| ANCOVA |
Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate |
| <0.001 |
| Difference in Least Squares Mean |
| -10.8 |
| 2-Sided |
| 95 |
| -13.2 |
| -8.4 |
| Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | 0.001 | Difference in Least Squares Mean | -6.4 | 2-Sided | 95 | -8.8 | -4.0 | Superiority or Other |
| ANCOVA | Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate | <0.001 | Difference in Least Squares Mean | -5.6 | 2-Sided | 95 | -8.0 | -3.2 | Superiority or Other |