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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)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypercholesterolemia

Intervention: Comparator: niacin + laropiprant (Drug); Comparator: niacin (Drug); Comparator: laropiprant (Drug); Comparator: placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, 4-Period, Crossover Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With Hypercholesterolemia

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Urinary 11-dehydrothromboxane B2 (11-dTxB2)

Secondary outcome: Prostaglandin I Metabolite (PGI-M)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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:

- 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.

Locations and Contacts

Additional Information

Starting date: August 2007
Last updated: July 31, 2015

Page last updated: August 23, 2015

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