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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_561 |
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The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a metabolite of thromboxane A2 (TxA2), as a marker of in vivo platelet reactivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | ER niacin/laropiprant + Placebo to laropiprant |
|
| B | Active Comparator | ER niacin + Placebo to laropiprant |
|
| C | Experimental | laropiprant + Placebo to ER niacin/laropiprant |
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| D | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: niacin + laropiprant | Drug | ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary 11-dehydrothromboxane B2 (11-dTxB2) | The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. | On Day 7 across the 24-hour urinary collection period. |
| Measure | Description | Time Frame |
|---|---|---|
| Prostaglandin I Metabolite (PGI-M) | The creatinine-normalized urine levels of PGI-M in the overall 24 hour collection interval following administration on Day 7. | On Day 7 across the 24-hour urinary collection period. |
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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 |
|---|---|---|---|
| 19833861 | Result | Lauring B, Dishy V, Luo WL, Laterza O, Patterson J, Cote J, Chao A, Larson P, Gutierrez M, Wagner JA, Lai E. Laropiprant in combination with extended-release niacin does not alter urine 11-dehydrothromboxane B2, a marker of in vivo platelet function, in healthy, hypercholesterolemic, and diabetic subjects. J Clin Pharmacol. 2009 Dec;49(12):1426-35. doi: 10.1177/0091270009339593. Epub 2009 Oct 15. |
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Phase I
First Patient Entered 16 Aug 2007.
Study conducted at Comprehensive Phase One, Miramar, FL. and Cedra Clinical Research LLC, San Antonio, TX.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: D/C/A/B | A = Extended Release (ER) niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days C = laropiprant 40 mg once daily for 7 days D = placebo once daily for 7 days |
| FG001 | Sequence 2: C/B/D/A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Comparator: niacin |
| Drug |
ER niacin 2 g tablet once daily for 7 days |
|
|
| Comparator: laropiprant | Drug | laropiprant 40 mg once daily for 7 days |
|
| Comparator: placebo | Drug | matching placebo tablets for each of the interventions once daily for 7 days |
|
A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days C = laropiprant 40 mg once daily for 7 days D = placebo once daily for 7 days |
| FG002 | Sequence 3: B/A/C/D | A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days C = laropiprant 40 mg once daily for 7 days D = placebo once daily for 7 days |
| FG003 | Sequence 4: A/D/B/C | A = ER niacin 2 g/laropiprant 40 mg once daily for 7 days B = ER niacin 2 g once daily for 7 days C = laropiprant 40 mg once daily for 7 days D = placebo once daily for 7 days |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Totals for Study | All participants in the study. |
| 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 |
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| Height | Mean | Full Range | cm |
| |||||||||||||||||
| Weight | Mean | Full Range | kg |
| |||||||||||||||||
| urinary 11-dTxB2 | urinary levels of 11-dehydrothromboxane B2 (24 hour collection) | Median | Full Range | pg/mg creatinine |
| ||||||||||||||||
| urinary PGI2-Metabolite | urinary levels of 2,3-dinor 6-keto-PGF1a (Prostaglandin I-M) 24-hour collection | Median | Full Range | pg/mg creatinine |
|
| 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 | Urinary 11-dehydrothromboxane B2 (11-dTxB2) | The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. | Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons. | Posted | Least Squares Mean | 95% Confidence Interval | pg/mg creatinine | On Day 7 across the 24-hour urinary collection period. |
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| Secondary | Prostaglandin I Metabolite (PGI-M) | The creatinine-normalized urine levels of PGI-M in the overall 24 hour collection interval following administration on Day 7. | Twenty-six (26) subjects (including replacements) were enrolled in this study. All available subjects (besides the 4 that were excluded due suspected NSAID/Aspirin use) and had partial data (at least one available period) were included in the statistical analysis models/comparisons. | Posted | Least Squares Mean | 95% Confidence Interval | pg/mg creatinine | On Day 7 across the 24-hour urinary collection period. |
|
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Although 26 participants were included in the assessment of safety, not all participants received all treatments.
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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 | ER Niacin 2 g / Laropiprant 40 mg | ER niacin 2 g/laropiprant 40 mg once daily for 7 days | 0 | 25 | 15 | 25 | ||
| EG001 | ER Niacin 2 g | ER niacin 2 g once daily for 7 days | 0 | 24 | 21 | 24 | ||
| EG002 | Laropiprant 40 mg | Laropiprant 40 mg once daily for 7 days | 0 | 25 | 4 | 25 | ||
| EG003 | Placebo | Placebo once daily for 7 days | 0 | 25 | 5 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA (10.1) |
| ||
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.1) |
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| Constipation | Gastrointestinal disorders | MedDRA (10.1) |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) |
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| Dry Mouth | Gastrointestinal disorders | MedDRA (10.1) |
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| Nausea | Gastrointestinal disorders | MedDRA (10.1) |
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| Vomiting | Gastrointestinal disorders | MedDRA (10.1) |
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| General Disorders And Administration Site Conditions | Gastrointestinal disorders | MedDRA (10.1) |
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| Musculoskeletal And Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | MedDRA (10.1) |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) |
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| Nervous System Disorders | Nervous system disorders | MedDRA (10.1) |
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| Headache | Nervous system disorders | MedDRA (10.1) |
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| Renal And Urinary Disorders | Renal and urinary disorders | MedDRA (10.1) |
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| Skin And Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | MedDRA (10.1) |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.1) |
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| Pruritus Generalised | Skin and subcutaneous tissue disorders | MedDRA (10.1) |
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| Vascular Disorders | Vascular disorders | MedDRA (10.1) |
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| Flushing | Vascular disorders | MedDRA (10.1) |
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Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| 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 |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C518174 | MK-0524 |
| D009525 | Niacin |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Geometric least-squares mean ratio | 0.87 | 90 | 0.71 | 1.07 | Superiority or Other (legacy) |
| Geometric least-squares mean ratio | 0.8 | 90 | 0.65 | 0.98 | Superiority or Other (legacy) |
| Geometric least-squares mean ratio | 0.89 | 90 | 0.72 | 1.09 | Superiority or Other (legacy) |
| Geometric least-squares mean ratio | 0.91 | 90 | 0.74 | 1.12 | Superiority or Other (legacy) |
| Geometric least-squares mean ratio | 1.02 | 90 | 0.83 | 1.25 | Superiority or Other (legacy) |
| Units | Counts |
|---|---|
| Participants |
|
|
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