Hypercholesterolemia, FamilialPhase 3ACHIEVENCT00384293

Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)

A Phase 3 study testing Comparator: niacin (+) laropiprant (MK0524A) in people with Hypercholesterolemia, Familial, 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

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Hypercholesterolemia, Familial
What is being tested?: Comparator: niacin (+) laropiprant (MK0524A)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 937 participants
Where: No sites listed yet
Study dates: Sep 2006to Aug 2008
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 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients who are 18 to 70 years of age with Heterozygous Familial Hypercholesterolemia and a LDL-C greater than or equal to 100mg/dL and triglycerides less than or equal to 400mg/dL at Visit 1 while on a stable dose of intensive LDL-C lowering therapy

Who cannot join

A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
Patients with less than 80% drug study compliance
Patients with chronic medical conditions known to influence serum lipids or lipoproteins or significantly affect the ultrasound acoustic window
Patients with unstable dose of medications
Pregnant or lactating women, or women intending to become pregnant are excluded
Patient with diabetes mellitus that is poorly controlled, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
Patients with the following conditions: high grade stenosis (greater than 75%) of the carotid artery, chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, episode of gout (within 1 year)

About this study

Official title: A Worldwide, Double-Blind, Randomized, Placebo-Controlled Study of MK0524A 2g Coadministered With Intensive LDL-C Lowering Therapy Compared to Intensive LDL-C Lowering Therapy Alone on Carotid Artery Intima Media Thickening (cIMT) in Patients With Heterozygous Familial Hypercholesterolemia (heFH)

This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima media thickening using ultrasound compared to patients taking placebo. There will be 12 scheduled clinic visits involving review of medical history, physical exam, vital signs, laboratory testing, ultrasound imaging, and electrocardiograms.

Conditions: Hypercholesterolemia, Familial
Being tested: Comparator: niacin (+) laropiprant (MK0524A), Comparator: placebo
Medical subject headings: Hyperlipoproteinemia Type II

What participants receive

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

Comparator: niacin (+) laropiprant (MK0524A)Drug
Also called MK0524A
niacin (+) laropiprant (2 g) po qd.
Comparator: placeboDrug
niacin (+) laropiprant (2 g) placebo po qd.

Study groups in NCT00384293
Study group	Role	What they receive
1	Experimental	MK0524A Receives: Drug: Comparator: niacin (+) laropiprant (MK0524A)
2	Placebo comparator	placebo Receives: Drug: Comparator: placebo

What is being measured

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

Change in Mean Carotid Intima Media Thickness
change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.
Measured: after 96 weeks of postrandomization treatment

Secondary outcomes (1)

Change in Lipid Profile
Measured: after 96 weeks of postrandomization treatment

Timeline

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

Sep 2006Aug 2008

First posted6 Oct 2006 (estimated)
Study startSep 2006
Primary completionAug 2008
Study completionAug 2008

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 Hypercholesterolemia, FamilialStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 937 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00384293
Sponsor's protocol ID: 0524A-041
Other IDs: 2006_506
Acronym: ACHIEVE
Status last verified: Sep 2015
First submitted: 3 Oct 2006
Last updated: 30 Sep 2015
Results posted: Yes, on ClinicalTrials.gov

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
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Not yet recruitingObservational study
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
Hypercholesterolaemia, Familial Hypercholesterolaemia
Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia

All Hypercholesterolemia, Familial trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Worldwide, Double-Blind, Randomized, Placebo-Controlled Study of MK0524A 2g Coadministered With Intensive LDL-C Lowering Therapy Compared to Intensive LDL-C Lowering Therapy Alone on Carotid Artery Intima Media Thickening (cIMT) in Patients With Heterozygous Familial Hypercholesterolemia (heFH)
ClinicalTrials.gov ID: NCT00384293
Acronym / sponsor ID: ACHIEVE / 0524A-041
Conditions: Hypercholesterolemia, Familial
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 937 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 6 Oct 2006 (estimated)
Results: Posted 2 Sep 2009

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Comparator: niacin (+) laropiprant (MK0524A)MK0524A
2	Placebo comparator	Drug: Comparator: placeboplacebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients who are 18 to 70 years of age with Heterozygous Familial Hypercholesterolemia and a LDL-C greater than or equal to 100mg/dL and triglycerides less than or equal to 400mg/dL at Visit 1 while on a stable dose of intensive LDL-C lowering therapy

Key exclusion criteria (7 listed)

A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
Patients with less than 80% drug study compliance
Patients with chronic medical conditions known to influence serum lipids or lipoproteins or significantly affect the ultrasound acoustic window
Patients with unstable dose of medications
Pregnant or lactating women, or women intending to become pregnant are excluded

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
Comparator: niacin (+) laropiprant (MK0524A)Also: MK0524Aniacin (+) laropiprant (2 g) po qd.	Drug	1
Comparator: placeboniacin (+) laropiprant (2 g) placebo po qd.	Drug	2

Primary outcome

Change in Mean Carotid Intima Media Thickness
Time frame: after 96 weeks of postrandomization treatment
change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.

1 secondary outcome

Change in Lipid Profile
Time frame: after 96 weeks of postrandomization treatment

Results and safety

Results posted to the registry on 2 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK0524A Active Run-In Period	937	433
MK0524A, 2 g (Postrandomization Period)	0	0
Placebo (Postrandomization Period)	0	0

Primary outcome: Change in Mean Carotid Intima Media Thickness

Time frame: after 96 weeks of postrandomization treatment

Population analysed: study prematurely terminated, no efficacy analyses were performed

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK0524A Active Run-In Period	10 of ?	395 of ?	Not reported
MK0524A, 2 g (Postrandomization Period)	5 of ?	74 of ?	Not reported
Placebo (Postrandomization Period)	8 of ?	54 of ?	Not reported

Limitations and caveats (from the sponsor): After a detailed review of pooled carotid IMT data from contemporary studies, the Steering Committee recommended that Merck prematurely stop the study; as designed, the study was significantly underpowered. Efficacy analyses were not performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypercholesterolemia, Familial

Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Not yet recruitingObservational study
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
Hypercholesterolaemia, Familial Hypercholesterolaemia
Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Comparator: niacin (+) laropiprant (MK0524A) in people with Hypercholesterolemia, Familial, 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 1 inclusion and 7 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 30 Sep 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 2 Sep 2009). 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?

Change in Mean Carotid Intima Media Thickness (time frame: after 96 weeks of postrandomization treatment). 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 NCT00384293.

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 30 Sep 2015.