CClinicalTrials.gg
CompletedNCT00769132Updated Nov 21, 2019Results posted

A Study to Evaluate the Effects of Extended Release (ER) Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With High Cholesterol (0524A-075)(COMPLETED)

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

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Aug 2007, registered Oct 2008).
Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypercholesterolemia
03

In context

Hypercholesterolemia

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female subjects may not be pregnant and/or will agree to use appropriate method of contraception beginning at least 2 weeks prior to administration of the first dose of study drug in the first treatment period, throughout the study and until at least 2 weeks after administration of the last dose of study drug in the last treatment period.
  • Subject is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug.
  • Subject has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug.
  • Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months; subjects who have discontinued smoking or the use of nicotine/nicotine containing products for at least approximately 3 months may be enrolled in the study at the discretion of the investigator

Exclusion criteria

Exclusion Criteria:

  • Subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 to 10 years. - Subjects who have had situational depression may be enrolled in the study at the discretion of the investigator.
  • Subject has a history of stroke, chronic seizures, or major neurological disorder.
  • Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
  • Subject has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment.
  • Subject has history of a thrombotic or platelet related disorder including prior deep venous thrombosis. Subject is being treated with coumadin, heparin, clopidogrel has used these agents within 2 weeks of screening. Subject is being treated with aspirin or has used this agent within 3 weeks prior to administration of screening.
  • Subject is unable to refrain from or anticipates the use of any medication, including prescription and non- prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the initial dose of study drug, throughout the study until the poststudy visit.
  • Subject consumes excessive amounts of alcohol, defined as greater than 3 glasses, of alcoholic beverages or distilled spirits per day.
  • Subject consumes excessive amounts, defined as greater than 6 servings, of coffee, tea, cola, or other caffeinated beverages per day.
  • Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit.
  • Subject has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.
  • Subject is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 6 months.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    A

    ER niacin/laropiprant + Placebo to laropiprant

    Drug: Comparator: niacin + laropiprant

  • Active comparator
    B

    ER niacin + Placebo to laropiprant

    Drug: Comparator: niacin

  • Experimental
    C

    laropiprant + Placebo to ER niacin/laropiprant

    Drug: Comparator: laropiprant

  • Placebo comparator
    D

    Placebo

    Drug: Comparator: placebo

Interventions

  • DrugComparator: niacin + laropiprant

    ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days

  • DrugComparator: niacin

    ER niacin 2 g tablet once daily for 7 days

    Also known as: Niaspan

  • DrugComparator: laropiprant

    laropiprant 40 mg once daily for 7 days

  • DrugComparator: placebo

    matching placebo tablets for each of the interventions once daily for 7 days

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

07

Results

Posted Nov 27, 2008

Participant flow

Phase I First Patient Entered 16 Aug 2007. Study conducted at Comprehensive Phase One, Miramar, FL. and Cedra Clinical Research LLC, San Antonio, TX.

Period 1
Participant flow — Period 1
MilestoneSequence 1: D/C/A/BSequence 2: C/B/D/ASequence 3: B/A/C/DSequence 4: A/D/B/C
Started7667
Completed6666
Not completed1001
Withdrew: Adverse event1001
Period 2
Participant flow — Period 2
MilestoneSequence 1: D/C/A/BSequence 2: C/B/D/ASequence 3: B/A/C/DSequence 4: A/D/B/C
Started6666
Completed6665
Not completed0001
Withdrew: Withdrawal by subject0001
Period 3
Participant flow — Period 3
MilestoneSequence 1: D/C/A/BSequence 2: C/B/D/ASequence 3: B/A/C/DSequence 4: A/D/B/C
Started6665
Completed5665
Not completed1000
Withdrew: Withdrawal by subject1000
Period 4
Participant flow — Period 4
MilestoneSequence 1: D/C/A/BSequence 2: C/B/D/ASequence 3: B/A/C/DSequence 4: A/D/B/C
Started5665
Completed5565
Not completed0100
Withdrew: Withdrawal by subject0100

Outcome measures

PrimaryUrinary 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.
Reported as:
Least squares mean · pg/mg creatinine
Urinary 11-dehydrothromboxane B2 (11-dTxB2)
pg/mg creatinineER Niacin 2 g / Laropiprant 40 mgER Niacin 2 gLaropiprant 40 mgPlacebo
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)
Statistical analysis
  • ER Niacin 2 g / Laropiprant 40 mg vs ER Niacin 2 g · Geometric least-squares mean ratio: 1.12 · 90% CI 0.9 to 1.38
  • Laropiprant 40 mg vs Placebo · Geometric least-squares mean ratio: 0.87 · 90% CI 0.71 to 1.07
  • ER Niacin 2 g vs Placebo · Geometric least-squares mean ratio: 0.8 · 90% CI 0.65 to 0.98
  • ER Niacin 2 g / Laropiprant 40 mg vs Placebo · Geometric least-squares mean ratio: 0.89 · 90% CI 0.72 to 1.09
  • ER Niacin 2 g vs Laropiprant 40 mg · Geometric least-squares mean ratio: 0.91 · 90% CI 0.74 to 1.12
  • ER Niacin 2 g / Laropiprant 40 mg vs Laropiprant 40 mg · Geometric least-squares mean ratio: 1.02 · 90% CI 0.83 to 1.25
SecondaryProstaglandin 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.
Reported as:
Least squares mean · pg/mg creatinine
Prostaglandin I Metabolite (PGI-M)
pg/mg creatinineER Niacin 2 g / Laropiprant 40 mgER Niacin 2 gLaropiprant 40 mgPlacebo
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)
Statistical analysis
  • ER Niacin 2 g / Laropiprant 40 mg vs ER Niacin 2 g · Geometric least-squares mean ratio: 1.04 · 90% CI 0.92 to 1.17
  • Laropiprant 40 mg vs Placebo · Geometric least-squares mean ratio: 0.9 · 90% CI 0.8 to 1.01
  • ER Niacin 2 g vs Placebo · Geometric least-squares mean ratio: 0.56 · 90% CI 0.49 to 0.63
  • ER Niacin 2 g / Laropiprant 40 mg vs Placebo · Geometric least-squares mean ratio: 0.58 · 90% CI 0.51 to 0.65
  • ER Niacin 2 g vs Laropiprant 40 mg · Geometric least-squares mean ratio: 0.62 · 90% CI 0.55 to 0.7
  • ER Niacin 2 g / Laropiprant 40 mg vs Laropiprant 40 mg · Geometric least-squares mean ratio: 0.64 · 90% CI 0.57 to 0.72

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
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%)
Most frequent other events
Showing 10 of 18
Most frequent other events
EventER Niacin 2 g / Laropiprant 40 mgER Niacin 2 gLaropiprant 40 mgPlacebo
Vascular DisordersVascular disorders8/2520/242/251/25
FlushingVascular disorders8/2520/242/251/25
Nervous System DisordersNervous system disorders8/255/242/253/25
Gastrointestinal DisordersGastrointestinal disorders7/257/243/253/25
HeadacheNervous system disorders7/254/241/253/25
Skin And Subcutaneous Tissue DisordersSkin and subcutaneous tissue disorders2/255/241/250/25
PruritusSkin and subcutaneous tissue disorders1/255/241/250/25
NauseaGastrointestinal disorders5/253/241/251/25
DiarrhoeaGastrointestinal disorders0/253/241/251/25
VomitingGastrointestinal disorders3/253/242/250/25

Baseline characteristics

Age, Continuous
Age, Continuous(years)Totals for Study
Mean48.1 ± 11.6
Sex: Female, Male
Sex: Female, Male(Participants)Totals for Study
Female14
Male12
Height
Height(cm)Totals for Study
Mean165.5 (147.0 to 185.0)
Weight
Weight(kg)Totals for Study
Mean78.4 (58.0 to 102.9)
urinary 11-dTxB2
urinary 11-dTxB2(pg/mg creatinine)Totals for Study
Median418.5 (142.0 to 783.1)
urinary PGI2-Metabolite
urinary PGI2-Metabolite(pg/mg creatinine)Totals for Study
Median89.7 (45.2 to 242.9)
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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. PubMed 19833861 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00769132
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Oct 8, 2008
Start date
Aug 3, 2007
Primary completion
Oct 13, 2007
Completion
Nov 6, 2007
Results posted
Nov 27, 2008
Last update
Nov 21, 2019

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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