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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_514 | Other Identifier | Sponsor Registry Number | |
| 2007-003684-41 | EudraCT Number | ||
| MK-6314-006 | Other Identifier | Merck Study Number |
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The purpose of this study is to test the safety and effectiveness of MK-6213 as compared to MK-6213/Atorvastatin in participants 18 to 75 years) with high cholesterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-6213 160 mg + Atorvastatin 20 mg | Experimental | 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks |
|
| Atorvastatin 20 mg | Active Comparator | 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks |
|
| MK-6213 160 mg | Experimental | 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks |
|
| Placebo | Placebo Comparator | 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-6213 | Drug | MK-6213 160 mg for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Blood collected at baseline (predose) and after 4 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by reflex beta-quantitation method. The percentage change from baseline at Week 4 was summarized. | Baseline (predose) and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience at Least 1 Adverse Event (AE) | An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized | Up to 14 days post last dose of study drug (up to 6 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-6213 160 mg + Atorvastatin 20 mg | 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks |
| FG001 | Atorvastatin 20 mg | 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks |
| FG002 | MK-6213 160 mg | 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks |
| FG003 | Placebo | 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-6213 160 mg + Atorvastatin 20 mg | 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks |
| BG001 | Atorvastatin 20 mg | 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks |
| 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 Low-density Lipoprotein Cholesterol (LDL-C) | Blood collected at baseline (predose) and after 4 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by reflex beta-quantitation method. The percentage change from baseline at Week 4 was summarized. | All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline (predose) and Week 4 |
|
up to 2 weeks post last dose (up to 6 weeks total)
Population included all participants that received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-6213 160 mg + Atorvastatin 20 mg | 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 11.1 | 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 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Atorvastatin calcium | Drug | atorvastatin calcium 20mg for 4 weeks. |
|
|
| Placebo for MK-6312 160 mg | Drug |
|
| Placebo for Atorvastatin 20 mg | Drug |
|
| Percentage of Participants That Had Study Drug Discontinued Due to an AE | An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized. | up to 4 weeks |
| Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Blood collected at baseline (predose) and after 4 weeks of treatment to determine non-HDL-C levels. The percentage change from baseline at Week 4 was summarized. | Baseline (predose) and Week 4 |
| Percentage Change From Baseline in Apolipoprotein B (ApoB) | Blood collected at baseline (predose) and after 4 weeks of treatment to determine ApoB levels. The percentage change from baseline at Week 4 was summarized. | Baseline (predose) and Week 4 |
| Percentage Change From Baseline in Total Cholesterol (TC) | Blood collected at baseline (predose) and after 4 weeks of treatment to determine TC levels. The percentage change from baseline at Week 4 was summarized. | Baseline (predose) and Week 4 |
| Percentage Change From Baseline in HDL-C | Blood collected at baseline (predose) and after 4 weeks of treatment to determine HDL-C levels. The percentage change from baseline at Week 4 was summarized. | Baseline (predose) and Week 4 |
| Percentage Change From Baseline in TG | Blood collected at baseline (predose) and after 4 weeks of treatment to determine TG levels. The percentage change from baseline at Week 4 was summarized. | Baseline (predose) and Week 4 |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG002 | MK-6213 160 mg | 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks |
| BG003 | Placebo | 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Atorvastatin 20 mg |
1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks |
| OG002 | MK-6213 160 mg | 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks |
| OG003 | Placebo | 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks |
|
|
|
| Secondary | Percentage of Participants Who Experience at Least 1 Adverse Event (AE) | An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized | All participants that received at least 1 dose for study drug. | Posted | Number | Percentage of Participants | Up to 14 days post last dose of study drug (up to 6 weeks) |
|
|
|
| Secondary | Percentage of Participants That Had Study Drug Discontinued Due to an AE | An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized. | All participants that received at least 1 dose for study drug. | Posted | Number | Percentage of Participants | up to 4 weeks |
|
|
|
| Secondary | Percentage Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Blood collected at baseline (predose) and after 4 weeks of treatment to determine non-HDL-C levels. The percentage change from baseline at Week 4 was summarized. | All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline (predose) and Week 4 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Apolipoprotein B (ApoB) | Blood collected at baseline (predose) and after 4 weeks of treatment to determine ApoB levels. The percentage change from baseline at Week 4 was summarized. | All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline (predose) and Week 4 |
|
|
|
|
| Secondary | Percentage Change From Baseline in Total Cholesterol (TC) | Blood collected at baseline (predose) and after 4 weeks of treatment to determine TC levels. The percentage change from baseline at Week 4 was summarized. | All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline (predose) and Week 4 |
|
|
|
|
| Secondary | Percentage Change From Baseline in HDL-C | Blood collected at baseline (predose) and after 4 weeks of treatment to determine HDL-C levels. The percentage change from baseline at Week 4 was summarized. | All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Change | Baseline (predose) and Week 4 |
|
|
|
|
| Secondary | Percentage Change From Baseline in TG | Blood collected at baseline (predose) and after 4 weeks of treatment to determine TG levels. The percentage change from baseline at Week 4 was summarized. | All participants that received at least 1 dose of study drug, had baseline value for parameter and had data available for timepoint. | Posted | Median | 95% Confidence Interval | Percentage of Participants | Baseline (predose) and Week 4 |
|
|
|
|
| 0 |
| 94 |
| 0 |
| 94 |
| 3 |
| 94 |
| EG001 | Atorvastatin 20 mg | 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks | 0 | 95 | 0 | 95 | 5 | 95 |
| EG002 | MK-6213 160 mg | 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks | 0 | 96 | 0 | 96 | 5 | 96 |
| EG003 | Placebo | 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks | 0 | 48 | 0 | 48 | 2 | 48 |
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
| D009750 |
| Nutritional and Metabolic Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions. |
| Diffence in Percentage Change |
| -13.9 |
| 2-Sided |
| 95 |
| -18.9 |
| -8.9 |
| Other |
LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions. |
| Difference in Percentage Change |
| -12.2 |
| 2-Sided |
| 95 |
| -16.8 |
| -7.6 |
| Other |
LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions. |
| Difference in Percentage Change |
| -11.0 |
| 2-Sided |
| 95 |
| -15.1 |
| -7.0 |
| Other |
LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions. |
| Difference in Percentage Change |
| -0.7 |
| 2-Sided |
| 95 |
| -5.8 |
| 4.4 |
| Other |
LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions. |
| Difference in Percentage Change |
| 5.5 |
| 2-Sided |
| 95 |
| -4.6 |
| 16.9 |
| Other |