A Phase 1 interventional study of Comparator: niacin + laropiprant and Comparator: niacin in Hypercholesterolemia, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-21.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
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.
1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.
This study's enrollment of 26 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ER niacin/laropiprant + Placebo to laropiprant
Drug: Comparator: niacin + laropiprant
ER niacin + Placebo to laropiprant
Drug: Comparator: niacin
laropiprant + Placebo to ER niacin/laropiprant
Drug: Comparator: laropiprant
Placebo
Drug: Comparator: placebo
ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days
ER niacin 2 g tablet once daily for 7 days
Also known as: Niaspan
laropiprant 40 mg once daily for 7 days
matching placebo tablets for each of the interventions once daily for 7 days
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.
Time frame: On Day 7 across the 24-hour urinary collection period.
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.
Time frame: On Day 7 across the 24-hour urinary collection period.
Phase I First Patient Entered 16 Aug 2007. Study conducted at Comprehensive Phase One, Miramar, FL. and Cedra Clinical Research LLC, San Antonio, TX.
| Milestone | Sequence 1: D/C/A/B | Sequence 2: C/B/D/A | Sequence 3: B/A/C/D | Sequence 4: A/D/B/C |
|---|---|---|---|---|
| Started | 7 | 6 | 6 | 7 |
| Completed | 6 | 6 | 6 | 6 |
| Not completed | 1 | 0 | 0 | 1 |
| Withdrew: Adverse event | 1 | 0 | 0 | 1 |
| Milestone | Sequence 1: D/C/A/B | Sequence 2: C/B/D/A | Sequence 3: B/A/C/D | Sequence 4: A/D/B/C |
|---|---|---|---|---|
| Started | 6 | 6 | 6 | 6 |
| Completed | 6 | 6 | 6 | 5 |
| Not completed | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 |
| Milestone | Sequence 1: D/C/A/B | Sequence 2: C/B/D/A | Sequence 3: B/A/C/D | Sequence 4: A/D/B/C |
|---|---|---|---|---|
| Started | 6 | 6 | 6 | 5 |
| Completed | 5 | 6 | 6 | 5 |
| Not completed | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 |
| Milestone | Sequence 1: D/C/A/B | Sequence 2: C/B/D/A | Sequence 3: B/A/C/D | Sequence 4: A/D/B/C |
|---|---|---|---|---|
| Started | 5 | 6 | 6 | 5 |
| Completed | 5 | 5 | 6 | 5 |
| Not completed | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
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.
| pg/mg creatinine | ER Niacin 2 g / Laropiprant 40 mg | ER Niacin 2 g | Laropiprant 40 mg | Placebo |
|---|---|---|---|---|
| Urinary 11-dehydrothromboxane B2 (11-dTxB2) | 414.6 (316.8 to 542.6) | 371.6 (283.8 to 486.5) | 407.3 (312.2 to 531.4) | 466.1 (358.4 to 606.3) |
The creatinine-normalized urine levels of PGI-M in the overall 24 hour collection interval following administration on Day 7.
| pg/mg creatinine | ER Niacin 2 g / Laropiprant 40 mg | ER Niacin 2 g | Laropiprant 40 mg | Placebo |
|---|---|---|---|---|
| Prostaglandin I Metabolite (PGI-M) | 73.5 (61.4 to 88.1) | 70.9 (59.2 to 85.0) | 114.5 (95.6 to 137.2) | 127.5 (106.6 to 152.4) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ER Niacin 2 g / Laropiprant 40 mg | — | 0/25 (0%) | 15/25 (60%) |
| ER Niacin 2 g | — | 0/24 (0%) | 21/24 (87.5%) |
| Laropiprant 40 mg | — | 0/25 (0%) | 4/25 (16%) |
| Placebo | — | 0/25 (0%) | 5/25 (20%) |
| Event | ER Niacin 2 g / Laropiprant 40 mg | ER Niacin 2 g | Laropiprant 40 mg | Placebo |
|---|---|---|---|---|
| Vascular DisordersVascular disorders | 8/25 | 20/24 | 2/25 | 1/25 |
| FlushingVascular disorders | 8/25 | 20/24 | 2/25 | 1/25 |
| Nervous System DisordersNervous system disorders | 8/25 | 5/24 | 2/25 | 3/25 |
| Gastrointestinal DisordersGastrointestinal disorders | 7/25 | 7/24 | 3/25 | 3/25 |
| HeadacheNervous system disorders | 7/25 | 4/24 | 1/25 | 3/25 |
| Skin And Subcutaneous Tissue DisordersSkin and subcutaneous tissue disorders | 2/25 | 5/24 | 1/25 | 0/25 |
| PruritusSkin and subcutaneous tissue disorders | 1/25 | 5/24 | 1/25 | 0/25 |
| NauseaGastrointestinal disorders | 5/25 | 3/24 | 1/25 | 1/25 |
| DiarrhoeaGastrointestinal disorders | 0/25 | 3/24 | 1/25 | 1/25 |
| VomitingGastrointestinal disorders | 3/25 | 3/24 | 2/25 | 0/25 |
| Age, Continuous(years) | Totals for Study |
|---|---|
| Mean | 48.1 ± 11.6 |
| Sex: Female, Male(Participants) | Totals for Study |
|---|---|
| Female | 14 |
| Male | 12 |
| Height(cm) | Totals for Study |
|---|---|
| Mean | 165.5 (147.0 to 185.0) |
| Weight(kg) | Totals for Study |
|---|---|
| Mean | 78.4 (58.0 to 102.9) |
| urinary 11-dTxB2(pg/mg creatinine) | Totals for Study |
|---|---|
| Median | 418.5 (142.0 to 783.1) |
| urinary PGI2-Metabolite(pg/mg creatinine) | Totals for Study |
|---|---|
| Median | 89.7 (45.2 to 242.9) |
No study locations are listed for this record.
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Merck Sharp & Dohme LLC