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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)

NCT00769132 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-11-21

Study results available
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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.

Conditions

Interventions

DRUG

Comparator: niacin + laropiprant

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

DRUG

Comparator: niacin

ER niacin 2 g tablet once daily for 7 days

DRUG

Comparator: laropiprant

laropiprant 40 mg once daily for 7 days

DRUG

Comparator: placebo

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-03
Primary Completion
2007-10-13
Completion
2007-11-06

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00769132 on ClinicalTrials.gov