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Primary HypercholesterolemiaPhase 3NCT01274559

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 Phase 3 study testing Extended-release niacin/laropiprant (ERN/LRPT) in people with Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Extended-release niacin/laropiprant (ERN/LRPT)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,173 participants
Where
No sites listed yet
Study dates
1 Mar 2011to 26 Feb 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • Not of reproductive potential is eligible without requiring the use of contraception. Definition of "not of reproductive potential": one who has either of the following:
  • reached natural menopause, defined as: 6 months of spontaneous amenorrhea with serum FSH levels (at Visit 1) in the postmenopausal range (per central lab) or 12 months of spontaneous amenorrhea.Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g., anorexia nervosa).
  • 6 weeks post surgical hysterectomy, or bilateral oophorectomy with or without hysterectomy.
  • Bilateral tubal ligation without subsequent restorative procedure.
  • Understands the study's procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.

Who cannot join

  • 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.
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  • 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.
  • intends to give or receive blood products during the study.
  • intends to donate more than 250 mL of blood products within 8 weeks following the last study visit.
  • Has the following exclusionary laboratory values at Visit 2
  • Creatinine clearance (eGFR) <30 mL/min (0.50 mL/s)
  • ALT (SGPT) >1.5 x ULN
  • AST (SGOT) >1.5 x ULN
  • CK >2 x ULN
  • Has used recreational or illicit drugs within 1 year of signing informed consent.
  • Was <80% compliant with LMT or placebo at Visit 2, AND in the opinion of the investigator, is believed to be unable to maintain at least 80% compliance with dosing during the active treatment period.
  • Has chronic heart failure defined by the New York Heart Association (NYHA) Classes III or IV, uncontrolled cardiac arrhythmias, or poorly controlled hypertension (systolic blood pressure >160 mm Hg or diastolic >100 mm Hg).
  • Has Type 1 or Type 2 diabetes mellitus and meets one or more of the following criteria:
  • Is poorly controlled (HbA1C >8.0% at Visit 1)
  • Is newly diagnosed (within 3 months of Visit 1)
  • Has recently experienced repeated hypoglycemia or unstable glycemic control (within 3 months of Visit 1).
  • Is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of ± ≤ 10 units of insulin) within 3 months of Visit 1.
  • Has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia such as hyper- or hypothyroidism.
  • Has nephrotic syndrome or other clinically significant renal disease.
  • Has active peptic ulcer disease within 3 months of Visit 1.
  • Has a history of hypersensitivity or allergic reaction to niacin or niacin containing products.
  • Has history of myocardial infarction, stroke, coronary artery bypass surgery or other revascularization procedure, unstable angina or angioplasty within 3 months of Visit 1.
  • Has arterial bleeding.
  • Has a history of ileal bypass, gastric bypass or other significant condition associated with malabsorption or rapid weight loss within 18 months of Visit 1.
  • Has active or chronic hepatobiliary or hepatic disease.
  • Is Chinese and is on simvastatin 80 mg or a product containing simvastatin 80 mg at Visit 1.
  • Is receiving treatment with systemic steroids (intravenous, injected, and oral steroids) OR systemic anabolic agents.
  • Consumes more than 3 alcoholic drinks on any given day or more than 14 drinks per week.
  • Is taking the following antioxidant vitamins each day:
  • Vitamin C in excess of 1500 mg
  • Vitamin E in excess of 45 IU for men, 36 IU for women
  • Beta Carotene 15000 IU for men, 12000 IU for women

About this study

Official title: 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

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.

Being tested
Extended-release niacin/laropiprant (ERN/LRPT), Placebo
Keywords
MK-0524A/ER, Hypercholesterolemia, Dyslipidemia, Niacin, Laropiprant
Medical subject headings
Hypercholesterolemia, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended-release niacin/laropiprant (ERN/LRPT)Drug

    1 oral 1 g tablet of ERN/LRPT to be taken with food in the evening or at bedtime for the first 4 weeks of treatment; then 2 oral 1g tablets of ERN/LRPT to be taken together in the evening or at bedtime with food for the next 8 weeks. Each 1g tablet contains 1g ERN and 20 mg LRPT

  • PlaceboDrug

    1 oral 1 g tablet of placebo to be taken with food in the evening or at bedtime for the first 4 weeks of treatment; then 2 oral 1g tablets of placebo to be taken together in the evening or at bedtime with food for the next 8 weeks.

Study groups in NCT01274559
Study groupRoleWhat they receive
Extended-release niacin/laropiprantExperimentalERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
Receives: Drug: Extended-release niacin/laropiprant (ERN/LRPT)
PlaceboPlacebo comparatorMatching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C)

    Measured: Baseline and Week 12

Secondary outcomes (22)

  1. Percent Change From Baseline in LDL-C:High-density Lipoprotein Cholesterol (HDL-C) at Week 12

    Measured: Baseline and Week 12

  2. Percent Change From Baseline in HDL-C at Week 12

    Measured: Baseline and Week 12

  3. Percent Change From Baseline in Triglyceride (TG) at Week 12

    Measured: Baseline and Week 12

  4. Percent Change From Baseline in Non-HDL-C at Week 12

    Measured: Baseline and Week 12

  5. Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 12

    Measured: Baseline and Week 12

  6. Percent Change From Baseline in Apo B:Apolipoprotein A-I (Apo A-I) at Week 12

    Measured: Baseline and Week 12

  7. Percent Change From Baseline in Total Cholesterol (TC):HDL-C at Week 12

    Measured: Baseline and Week 12

  8. Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 12

    Measured: Baseline and Week 12

  9. Percent Change From Baseline in Apo A-I at Week 12

    Measured: Baseline and Week 12

  10. Percent Change From Baseline in TC at Week 12

    Measured: Baseline and Week 12

  11. Percent Change From Baseline in LDL-C at Week 4

    Measured: Baseline and Week 4

  12. Percent Change From Baseline in LDL-C:HDL-C at Week 4

    Measured: Baseline and Week 4

  13. Percent Change From Baseline in HDL-C at Week 4

    Measured: Baseline and Week 4

  14. Percent Change From Baseline in TG at Week 4

    Measured: Baseline and Week 4

  15. Percent Change From Baseline in Non-HDL-C at Week 4

    Measured: Baseline and Week 4

  16. Percent Change From Baseline in Apo B at Week 4

    Measured: Baseline and Week 4

  17. Percent Change From Baseline in Apo B:Apo A-I at Week 4

    Measured: Baseline and Week 4

  18. Percent Change From Baseline in TC:HDL-C at Week 4

    Measured: Baseline and Week 4

  19. Percent Change From Baseline in Lp(a) at Week 4

    Measured: Baseline and Week 4

  20. Percent Change From Baseline in Apo A-I at Week 4

    Measured: Baseline and Week 4

  21. Percent Change From Baseline in TC at Week 4

    Measured: Baseline and Week 4

  22. Number of Participants Who Achieve LDL-C Target Levels at Week 12 of Treatment

    assessed as per National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) and European Society of Cardiology (ESC) treatment guidelines

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2011 (estimated)
  2. Study start1 Mar 2011
  3. Primary completion26 Feb 2013
  4. Study completion26 Feb 2013

Why it stopped: In HPS2-THRIVE, MK-0524A did not meet the primary efficacy objective and there was a significant increase in incidence of some types of non-fatal SAEs

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01274559
Sponsor's protocol ID
0524A-133
Other IDs
CTRI/2012/08/002857, 2010-021627-27
Status last verified
May 2024
First submitted
25 Oct 2010
Last updated
22 May 2024
Data monitoring committee
No
Individual data sharing
Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Extended-release niacin/laropiprant (ERN/LRPT) in people with Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline at Week 12 in Low Density Lipoprotein-Cholesterol (LDL-C) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01274559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.

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