A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102)
January 29, 2015 updated by: Merck Sharp & Dohme LLC
A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Long-term Efficacy, Safety and Tolerability of ERN/LRPT in Patients With Dyslipidemia
This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms beyond 6 months and will measure the impact of withdrawal of laropiprant in patients following 20 weeks of stable maintenance therapy.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
1152
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient is a male, or a female who is unlikely to conceive, as indicated by meeting at least one of the following conditions: (a) Patient is a male.(b) Patient is a female of reproductive potential and either agrees to remain abstinent (if this form of birth control is accepted by local regulatory agencies and review committees as the sole method of birth control) or use (or have their partner use) 2 acceptable methods of birth control within the projected duration of the study.(c) Patient is a female who is not of reproductive potential and therefore eligible to participate in this study without requiring the use of contraception.
- Lipid-modifying therapy (LMT) is appropriate for the patient
- Patient meets one of the following criteria based on the National Cholesterol Education Program Adult Treatment Panel III guidelines : 1) High risk and is on a statin with LDL-cholesterol (LDL-C) <100 mg/dL or intolerant to statins with LDL-C <120 mg/dL; 2) Multiple risk with LDL-C <130 mg/dL; 3) Low risk with LDL-C <190 mg/dL
- Patient has triglyceride levels <500 mg/dL
Exclusion Criteria:
- Patient is pregnant, breast-feeding, or expecting to conceive
- Patient has a history of cancer within 5 years of screening (except certain skin and cervical cancers)
- Female patient plans to donate eggs during the study
- Male patient plans to donate sperm during the study
- Patient has or has a history of any condition, therapy, or lab abnormality that might confound the study results, interfere with participation for the full duration of the study, or make participation in the study not in the patient's best interest
- Patient has donated or received blood within 8 weeks of screening or plans to donate/receive blood during and 8 weeks after the study
- Patient is experiencing menopausal hot flashes
- Patient has chronic heart failure, uncontrolled cardiac arrhythmias, or poorly controlled hypertension
- Patient has type 1 or 2 diabetes and is poorly-controlled, newly diagnosed, has recently had repeated hypoglycemia, or is taking new or recently adjusted antidiabetic medication
- Patient has uncontrolled metabolic or endocrine disease that influences serum lipids or lipoproteins
- Patient has kidney disease
- Patient had active peptic ulcers within 3 months of screening
- Patient has a history of heart attack, stroke, heart bypass surgery, angina, or angioplasty within 3 months of screening
- Patient is human immunodeficiency virus (HIV) positive
- Patient is taking or has taken niacin >50 mg daily within 6 weeks of screening
- Patient has had a change to type or dose of LMT regimen within 6 weeks of Visit 1
- Patient is taking a statin and a fibrate at screening
- Patient is taking a long acting non-steroidal anti-inflammatory drug (NSAID), such as naproxen or aspirin >100 mg per day at screening
- Patient has arterial bleeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ERN/LRPT
One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks |
One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks.
|
|
Experimental: ERN/LRPT then ERN
One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
|
One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks.
Two 1g tablets ERN (2g total) once daily for 12 weeks.
|
|
Placebo Comparator: Placebo
One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
|
One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period
Time Frame: Week 21 to Week 32
|
Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme).
The number of days/week was derived as: 7*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period).
The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, >0 to 0.5, >0.5 to 1, >1 to 2, >2 to 3, and >3 days per week.
|
Week 21 to Week 32
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period
Time Frame: Week 21 to Week 32
|
Flushing symptoms were recorded using participant's response to the Global Flushing Severity Score (GFSS), which assesses the overall severity of the flushing experience (including redness, warmth, tingling, or itching) using a scale with response categories of None, Mild, Moderate, Severe, and Extreme.
The categories were supplemented with numbers 0 to 10 to allow for greater precision within each category (None=0, Mild=1-3, Moderate=4-6, Severe=7-9, Extreme=10).
The daily response was recorded in the morning, and reflected the symptoms experienced during the previous 24 hours.
|
Week 21 to Week 32
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
August 17, 2009
First Submitted That Met QC Criteria
August 18, 2009
First Posted (Estimate)
August 19, 2009
Study Record Updates
Last Update Posted (Estimate)
February 16, 2015
Last Update Submitted That Met QC Criteria
January 29, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0524A-102
- 2009_634
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.