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Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)

A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

NCT01274559•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study in participants with primary hypercholesterolemia or mixed dyslipidemia, and elevated low density lipoprotein-cholesterol (LDL-C) to assess the efficacy and safety of extended release (ER) niacin/laropiprant \[ERN/LRPT (MK-0524A)\] when added to the following ongoing lipid-modifying therapy (LMT): simvastatin, atorvastatin, rosuvastatin monotherapy, ezetimibe/simvastatin fixed dose combination (FDC), or any statin co-administered with ezetimibe. The study is based on the hypothesis that ERN/LRPT 2 g daily will be superior to placebo at lowering LDL-C at Week 12 of treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has a history of primary hypercholesterolemia or mixed dyslipidemia.
•Must meet one of the risk categories (very high, high or moderate and corresponding LDL-C criteria at Visit 2.
•Has TG levels \<500 mg/dL (\<5.65 mmol/L).
•Has been on a stable dose of one of the following lipid-modifying therapies (LMTs)for at least 6 weeks prior to Visit 1, and agrees to remain on the same type and dose of LMT for the duration of the study:
•* Monotherapy: any statin
•* Combination Therapy: ezetimibe/simvastatin in the same tablet
•* Co-administration Therapy: any statin co-administered with ezetimibe
•Is male or female and ≥18 years of age on day of signing informed consent.
•A female must meet ONE of the following:
•* Of reproductive potential and agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the study duration.
+5 more criteria

Exclusion Criteria

•\- Has taken a prohibited LMT within 6 weeks of Visit 1. Examples of
•prohibited LMT include bile acid sequestrants, fibrates (monotherapy, coadministration or combination with other LMT), niacin \>50 mg, and red yeast rice products.
•Has had a change to the type or dose of acceptable LMT regimen within 6 weeks of Visit 1.
•Is pregnant, breastfeeding, or expecting to conceive during the study including the 14-day poststudy follow-up.
•Has a history of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
•Female who is expecting to donate eggs during the study, including the 14-day follow-up.
•Is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
•Has participated in a study, including post-study follow-up, with an investigational compound (non-lipid-modifying) within 30 days of Visit 1 or a lipid-modifying compound (investigational or marketed), within 6 weeks of Visit 1.
•Has donated and/or received blood as follows:
•* donated blood products or has had phlebotomy of \>300 mL within 8 weeks prior to signing informed consent.
+30 more criteria

Key Dates

Start Date

March 1, 2011

Primary Completion Date

February 26, 2013

Completion Date

February 26, 2013

Last Updated

May 22, 2024

Enrollment

1,173

ACTUAL participants

Conditions

Primary HypercholesterolemiaMixed Dyslipidemia

Interventions

Extended-release niacin/laropiprant (ERN/LRPT)

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib

A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and PA-111A

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