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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_508 |
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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 specific metabolite (which is a marker of in vivo platelet reactivity).
Subjects will receive 1 of 4 treatments per period and will eventually receive all 4 treatments:
Treatment A: ER niacin 2g/laropiprant 40 mg daily + Placebo to laropiprant for 7 days
Treatment B: ER niacin 2 g daily + Placebo to laropiprant for 7
days
Treatment C: laropiprant 40 mg daily + Placebo to ER niacin/laropiprant for 7 days
Treatment D: placebo daily for 7 days. There will be at least a 7-day interval between dosing on Day 7 of a period and dosing on Day 1 of the subsequent period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Arm A: ER niacin/laropiprant + Placebo to laropiprant |
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| B | Experimental | Arm B: ER niacin + Placebo to laropiprant |
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| C | Experimental | Arm C: laropiprant + Placebo to ER Niacin/laropiprant |
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| D | Placebo Comparator | Arm D: Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: ER niacin (+) laropiprant | Drug | ER niacin 2 g/ laropiprant 40 mg 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) | 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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Subjects were treated either w/diet and exercise alone, or with metformin, or a sulfonylurea, and had to be on stable meds for >= 8 wks pre-study.
Phase I
First Patient Enrolled 21 Aug 2007, First Patient Treated 7 Sept 2007.
Study conducted at 3 centers: Arkansas Research Medical Testing, LLC, Little Rock, AR; Healthcare Discoveries Inc., San Antonio, TX; and Comprehensive Phase One, Fort Myers, FL. Merck's ER Niacin was used.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: D/C/A/B | 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 |
| FG001 | Sequence 2: C/B/D/A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Comparator: ER niacin |
| Drug |
ER niacin 2 g daily for 7 days. |
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| Comparator: laropiprant | Drug | laropiprant 40 mg daily for 7 days. |
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| Comparator: placebo | Drug | matching placebo tablets for each of the interventions once daily for 7 days |
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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 |
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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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Height | Mean | Full Range | cm |
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| Weight | Mean | Full Range | kg |
| |||||||||||||||||
| urinary 11-dTxB2 | urinary levels of 11-dehydrothromboxane B2 (24-hour collection) | Median | Full Range | pg/mg creatinine |
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| urinary PGI2-Metabolite | urinary levels of 2,3-dinor 6-keto-PGF1a (Prostaglandin I-M) 24 hour collection | Median | Full Range | pg/mg creatinine |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 2 that were excluded due to suspected NSAID/Aspirin use) who complied with the protocol and had partial data were included in the subsequent 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) | 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 2 that were excluded due to suspected NSAID/Aspirin use) who complied with the protocol and had partial data were included in the subsequent 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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| 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/Laropiprant | Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days | 0 | 23 | 17 | 23 | ||
| EG001 | ER Niacin | ER Niacin 2 g once daily for 7 days | 1 | 25 | 23 | 25 | ||
| EG002 | Laropiprant | Laropiprant 40 mg once daily for 7 days | 0 | 23 | 12 | 23 | ||
| EG003 | Placebo | Placebo once daily for 7 days | 0 | 22 | 11 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) |
| ||
| Acidosis | Metabolism and nutrition disorders | MedDRA (10.1) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (10.1) |
| ||
| Abdominal Distension | Gastrointestinal disorders | MedDRA (10.1) |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.1) |
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| Abdominal Pain Upper | 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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| Dyspepsia | 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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| Asthenia | General disorders | MedDRA (10.1) |
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| Feeling Hot | General disorders | MedDRA (10.1) |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.1) |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) |
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| Burning Sensation | Nervous system disorders | MedDRA (10.1) |
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| Dizziness | Nervous system disorders | MedDRA (10.1) |
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| Headache | Nervous system disorders | MedDRA (10.1) |
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| Paraesthesia | Nervous system disorders | MedDRA (10.1) |
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| Erythema | 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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| 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 |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C518174 | MK-0524 |
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| Geometric least-squares mean ratio | 0.94 | 90 | 0.77 | 1.14 | No | Superiority or Other |
| Geometric least-squares mean ratio | 0.87 | 90 | 0.71 | 1.05 | No | Superiority or Other |
| Geometric least-squares mean ratio | 0.84 | 90 | 0.69 | 1.02 | No | Superiority or Other |
| Geometric least-squares mean ratio | 0.92 | 90 | 0.76 | 1.13 | No | Superiority or Other |
| Geometric least-squares mean ratio | 0.9 | 90 | 0.74 | 1.09 | No | Superiority or Other |
| Units | Counts |
|---|---|
| Participants |
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