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Heterozygous Familial Hypercholesterolemia (HeFH)Phase 3NCT01824238

A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050)

A Phase 3 study testing Anacetrapib in people with Heterozygous Familial Hypercholesterolemia (HeFH), run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying therapy. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Anacetrapib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
No sites listed yet
Study dates
May 2013to May 2014
Phase
Phase 3
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • If female, cannot be of reproductive potential
  • Diagnosed with heterozygous familial hypercholesterolemia
  • Have been treated with an appropriate and
  • stable dose of statin± other lipid-lowering medication(s) for at least 6 weeks

Who cannot join

  • Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
  • Homozygous familial hypercholesterolemia
  • Severe chronic heart failure
  • Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months

About this study

Official title: A 12-Week, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Safety of MK-0859 When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Therapies in Japanese Patients With Heterozygous Familial Hypercholesterolemia

This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with heterozygous familial hypercholesterolemia when added to an existing statin lipid-modifying therapy.

Being tested
Anacetrapib, Placebo for anacetrapib

What participants receive

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

  • AnacetrapibDrug

    Also called MK-0859

  • Placebo for anacetrapibDrug

Study groups in NCT01824238
Study groupRoleWhat they receive
AnacetrapibExperimentalParticipants will receive 100-mg anacetrapib tablet, orally, once-daily for 12 weeks.
Receives: Drug: Anacetrapib
PlaceboPlacebo comparatorParticipants will receive placebo tablet, orally, once daily for 12 weeks.
Receives: Drug: Placebo for anacetrapib

What is being measured

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

  1. Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)

    Measured: Baseline and Week 12

  2. Percentage of Participants who Experience at Least One Adverse Event (AE)

    Measured: 12 weeks

Secondary outcomes (5)

  1. Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C)

    Measured: Baseline and Week 12

  2. Percent Change from Baseline in Non-HDL-C

    Measured: Baseline and Week 12

  3. Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)

    Measured: Baseline and Week 12

  4. Percent Change from Baseline in Apolipoprotein B (Apo-B)

    Measured: Baseline and Week 12

  5. Percent Change from Baseline in Lipoprotein(a) (Lp[a])

    Measured: Baseline and Week 12

Timeline

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

  1. First posted4 Apr 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionMay 2014
  4. Study completionMay 2014

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
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01824238
Sponsor's protocol ID
0859-050
Other IDs
132234
Status last verified
Apr 2016
First submitted
1 Apr 2013
Last updated
25 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Arai H, Teramoto T, Daida H, Ikewaki K, Maeda Y, Nakagomi M, Shirakawa M, Kakikawa T, Numaguchi H, Johnson-Levonas AO, Vaidya S, Blaustein RO. Efficacy and safety of the cholesteryl ester transfer protein inhibitor anacetrapib in Japanese patients with heterozygous familial hypercholesterolemia. Atherosclerosis. 2016 Jun;249:215-23. doi: 10.1016/j.atherosclerosis.2016.03.017. Epub 2016 Mar 25.

    PubMed 27131642

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anacetrapib in people with Heterozygous Familial Hypercholesterolemia (HeFH), 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 25 Apr 2016. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 LDL-C (beta-quantification [BQ] method) (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. 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 NCT01824238, which also lists 1 linked publication.

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 25 Apr 2016.

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