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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_689 |
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This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 will be open-label and will evaluate single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 | Experimental | In Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days). |
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| Period 2 | Experimental | In Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days). |
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| Period 3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| niacin (+) laropiprant | Drug | open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous Bleeding Time (BT) | Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days. The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable. Period 3 was not analyzed as bleeding time was not an objective for this part of the study. | Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24206527 | Result | De Kam PJ, Luo WL, Wenning L, Ratcliffe L, Sisk CM, Royalty J, Radziszewski W, Wagner JA, Lai E. The effects of laropiprant on the antiplatelet activity of co-administered clopidogrel and aspirin. Platelets. 2014;25(7):480-7. doi: 10.3109/09537104.2013.836747. Epub 2013 Nov 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Periods 1 and 2 evaluated the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Comparator: aspirin | Drug | 81 mg oral tablet once daily for 7 days |
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| Comparator: clopidogrel | Drug | 75 mg oral tablet once daily for 7 days |
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| Comparator: laropiprant | Drug | 40 mg oral tablet once daily for 7 days |
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| Comparator: placebo | Drug | placebo oral tablet once daily for 7 days |
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| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Periods 1 and 2 evaluated the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Cutaneous Bleeding Time (BT) | Cutaneous bleeding Time (BT) on Day 8 after daily administration of laropiprant with aspirin and clopidogrel for 7 days versus BT on Day 8 after daily administration of placebo with aspirin and clopidogrel for 7 days. The model used included treatment, period and sequence as fixed effect variables and subjects as the random effect variable. Period 3 was not analyzed as bleeding time was not an objective for this part of the study. | Due to technical reasons, bleeding time was zero for some participants; they were considered to be missing data. Therefore, these observations were excluded from the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Seconds | Day 8 |
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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 | Laropiprant + Clopidrogel + Aspirin | Participants from Periods 1 and 2 | 0 | 36 | 24 | 36 | ||
| EG001 | Clopidogrel + Aspirin | Participants from Periods 1 and 2 | 0 | 36 | 23 | 36 | ||
| EG002 | Laropiprant + Niacin | Participants from Period 3 | 0 | 20 | 20 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Vessel puncture site haemorrhage | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
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| Vasodilation | Vascular disorders | MedDRA 13.0 | 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 |
|---|---|
| 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 |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| C518174 | MK-0524 |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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