DyslipidemiaPhase 3NCT01414166

Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)

A Phase 3 study testing ERN/LRPT in people with Dyslipidemia, run by Merck Sharp & Dohme LLC.

Terminated

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

Trial summary

The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination tablets in a primary prevention population currently not taking or eligible for lipid-modifying therapy (LMT); the population will comprise participants with low to moderate risk for coronary heart disease (CHD), low high… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dyslipidemia
What is being tested?: ERN/LRPT
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 244 participants
Where: No sites listed yet
Study dates: Sep 2011to 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

LMT ineligible
Participants must meet the lipid criteria of "low to moderate CHD risk" as defined by National Cholesterol Education Program Adult Treatment Panel III Framingham Point Scores (NCEP ATP III)
HDL-C <40 mg/dL (1.03 mmol/L) in males and <50 mg/dL (1.29 mmol/L) in females
Triglyceride (TG) level <300 mg/dL (3.39 mmol/L).
Fasting serum glucose (FSG) at Visit 1 AND Visit 2 <126 mg/dL (<7 mmol/L)
Hemoglobin A1c (HbA1c) level <6.5%
Participant willing to use acceptable method of contraception during the study, including the 14-day follow-up period

Who cannot join

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
Participation in a study with an investigational compound (non-lipid-modifying) within 30 days
Pregnant, breastfeeding, or expecting to conceive, or father a child during the study, including the 14-day follow-up period
Consumption of more than 3 alcoholic drinks on any given day or more than 14 drinks per week
Engages in or plans to engage in vigorous exercise or an aggressive diet regimen during the study
Diabetes mellitus, based on medical history, FSG ≥126 mg/dL (7 mmol/L), and HbA1c ≥6.5%

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Risk factors for coronary heart disease
Active or chronic hepatobiliary or hepatic disease
Active peptic ulcer disease within 3 months of Visit 1
History of hypersensitivity or allergic reaction to niacin or niacin-containing products
Episode of gout within 1 year of Visit 1, unless currently stable on allopurinol
Taking an LMT (including statins, bile acid sequestrants, fibrates and niacin >50 mg as monotherapy or coadministered with other LMTs)
Use of over-the- counter or traditional medicine (e.g. red yeast rice products) for lipid-lowering
Receiving treatment with systemic corticosteroids (unless on stable therapy for at lest 6 weeks for replacement for pituitary/adrenal/hypogonadal disease)
Uncontrolled illness or infection

About this study

Official title: A 16-Week, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Extended Release Niacin/Laropiprant in South and Southeast Asians Not on a Lipid Modulating Agent, With Decreased High-Density Lipoprotein Cholesterol and Low- Density Lipoprotein Cholesterol at or Below NCEP ATP III Goal

Conditions: Dyslipidemia
Being tested: ERN/LRPT, placebo
Medical subject headings: Dyslipidemias

What participants receive

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

ERN/LRPTDrug
Also called Tredaptive™
ERN/LRPT combination tablets (each containing 1 g of extended release niacin and 20 mg of laropiprant), orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks
placeboDrug
ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks

Study groups in NCT01414166
Study group	Role	What they receive
ERN/LRPT group	Experimental	All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive ERN/LRPT for 16 weeks. Receives: Drug: ERN/LRPT
Placebo group	Placebo comparator	All participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive placebo for 16 weeks. Receives: Drug: placebo

What is being measured

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

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16
The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.
Measured: Baseline and Weeks 12 to 16

Secondary outcomes (8)

Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16
The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16.
Measured: Baseline and Week 16
Percent Change From Baseline in HDL-C at Week 16
The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16.
Measured: Baseline and Week 16
Percent Change From Baseline in Triglycerides (TG) at Week 16
The percentage change from baseline in participants' TG level was to be evaluated at study Week 16.
Measured: Baseline and Week 16
Percent Change From Baseline in Non-HDL-C at Week 16
The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16.
Measured: Baseline and Week 16
Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16
The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16.
Measured: Baseline and Week 16
Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16
The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16.
Measured: Baseline and Week 16
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16
The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16.
Measured: Baseline and Week 16
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16
The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16.
Measured: Baseline and Week 16

Timeline

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

Sep 2011Feb 2013

First posted11 Aug 2011 (estimated)
Study startSep 2011
Primary completionFeb 2013
Study completionFeb 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

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DyslipidemiaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 244 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01414166
Sponsor's protocol ID: 0524A-108
Other IDs: CTRI/2012/08/002873
Status last verified: Apr 2015
First submitted: 9 Aug 2011
Last updated: 13 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease

All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 16-Week, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Extended Release Niacin/Laropiprant in South and Southeast Asians Not on a Lipid Modulating Agent, With Decreased High-Density Lipoprotein Cholesterol and Low- Density Lipoprotein Cholesterol at or Below NCEP ATP III Goal
ClinicalTrials.gov ID: NCT01414166
Acronym / sponsor ID: 0524A-108
Conditions: Dyslipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason 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
Enrolment: 244 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 11 Aug 2011 (estimated)
Results: Posted 14 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ERN/LRPT group	Experimental	Drug: ERN/LRPTAll participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive ERN/LRPT for 16 weeks.
Placebo group	Placebo comparator	Drug: placeboAll participants will begin with a screening period of 1 week, followed by a placebo run-in period of 2 weeks before being randomized to receive placebo for 16 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

LMT ineligible
Participants must meet the lipid criteria of "low to moderate CHD risk" as defined by National Cholesterol Education Program Adult Treatment Panel III Framingham Point Scores (NCEP ATP III)
HDL-C <40 mg/dL (1.03 mmol/L) in males and <50 mg/dL (1.29 mmol/L) in females
Triglyceride (TG) level <300 mg/dL (3.39 mmol/L).
Fasting serum glucose (FSG) at Visit 1 AND Visit 2 <126 mg/dL (<7 mmol/L)

Key exclusion criteria (15 listed)

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
Participation in a study with an investigational compound (non-lipid-modifying) within 30 days
Pregnant, breastfeeding, or expecting to conceive, or father a child during the study, including the 14-day follow-up period
Consumption of more than 3 alcoholic drinks on any given day or more than 14 drinks per week
Engages in or plans to engage in vigorous exercise or an aggressive diet regimen during the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ERN/LRPTAlso: Tredaptive™ERN/LRPT combination tablets (each containing 1 g of extended release niacin and 20 mg of laropiprant), orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks	Drug	ERN/LRPT group
placeboERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks	Drug	Placebo group

Primary outcome

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16
Time frame: Baseline and Weeks 12 to 16
The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.

8 secondary outcomes

Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in HDL-C at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in Triglycerides (TG) at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in Non-HDL-C at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16
Time frame: Baseline and Week 16
Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16
Time frame: Baseline and Week 16

Results and safety

Results posted to the registry on 14 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ERN/LPRT	122	31
Placebo	122	39

Primary outcome: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16

Time frame: Baseline and Weeks 12 to 16

Population analysed: Due to early study termination, this efficacy endpoint was not analyzed.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 20 for Serious Adverse Events; Up to Week 18 for Non-Serious Adverse Events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ERN/LPRT	1 of 120 (0.8%)	42 of 120 (35%)	Not reported
Placebo	0 of 121 (0%)	17 of 121 (14%)	Not reported

Limitations and caveats (from the sponsor): Due to the small number of participants completing the study (n=70), the resulting underpowered nature of any analyses that might be conducted, and the fact that data are not going to be used, no efficacy analyses were performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dyslipidemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ERN/LRPT in people with 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 7 inclusion and 15 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 13 May 2015. 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 in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16 (time frame: Baseline and Weeks 12 to 16). 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 NCT01414166.

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 13 May 2015.