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)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00769132
First received: October 7, 2008
Last updated: November 23, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: Comparator: niacin + laropiprant Drug: Comparator: niacin Drug: Comparator: laropiprant Drug: Comparator: placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Urinary 11-dehydrothromboxane B2 (11-dTxB2) [ Time Frame: On Day 7 across the 24-hour urinary collection period. ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Prostaglandin I Metabolite (PGI-M) [ Time Frame: On Day 7 across the 24-hour urinary collection period. ] [ Designated as safety issue: No ]The creatinine-normalized urine levels of PGI-M in the overall 24 hour collection interval following administration on Day 7.
| Enrollment: | 26 |
| Study Start Date: | August 2007 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
ER niacin/laropiprant + Placebo to laropiprant
|
Drug: Comparator: niacin + laropiprant
ER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days
|
|
Active Comparator: B
ER niacin + Placebo to laropiprant
|
Drug: Comparator: niacin
ER niacin 2 g tablet once daily for 7 days
Other Name: Niaspan
|
|
Experimental: C
laropiprant + Placebo to ER niacin/laropiprant
|
Drug: Comparator: laropiprant
laropiprant 40 mg once daily for 7 days
|
|
Placebo Comparator: D
Placebo
|
Drug: Comparator: placebo
matching placebo tablets for each of the interventions once daily for 7 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00769132 History of Changes |
| Other Study ID Numbers: | MK-0524A-075, 2008_561 |
| Study First Received: | October 7, 2008 |
| Results First Received: | October 30, 2008 |
| Last Updated: | November 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Niacin Nicotinic Acids Niacinamide Vasodilator Agents Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013