AzTrials
AzTrials

HypercholesterolemiaPhase 3NCT01717300

A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy (MK-0859-021)

A Phase 3 study testing Anacetrapib 100 mg and Anacetrapib 25 mg in people with Hypercholesterolemia, 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
Search all trials

Trial summary

This study will evaluate the effects of 2 different dose levels of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with hypercholesterolemia when added to an existing statin-modifying therapy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypercholesterolemia
What is being tested?
Anacetrapib 100 mg and Anacetrapib 25 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
459 participants
Where
No sites listed yet
Study dates
6 Nov 2012to 29 Oct 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
  • Have been treated with an optimal dose of statin for at least 6 weeks
  • Coronary heart disease (CHD) or other atherosclerotic vascular disease with multiple risk factors (including diabetes, metabolic syndrome) and/or high LDL-C/low HDL-C, or needing to meet a specific LDL-C/HDL-C goal

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
  • Uncontrolled hypertension
  • Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
Show all 16Show fewer
  • Active or chronic hepatobiliary, hepatic, or gall bladder disease
  • History of mental instability, drug/alcohol abuse within the past five years or major psychiatric illness inadequately controlled and unstable
  • History of ileal bypass, gastric bypass, or other significant condition associated with malabsorption
  • Human immunodeficiency virus (HIV) positive
  • History of malignancy ≤5 years
  • Donated blood products or has had phlebotomy of >300 mL within 8 weeks or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study
  • Currently taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A) (including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John's wort) or has discontinued treatment <3 weeks prior
  • Consumes more than 2 alcoholic drinks per day
  • Currently participating or has participated in a study with an investigational compound or device within 3 months
  • Receiving treatment with systemic corticosteroids or taking systemic anabolic agents

About this study

Official title: A 24-Week, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients With Hypercholesterolemia or Low HDL-C

This study will evaluate the effects of 2 different dose levels of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with hypercholesterolemia when added to an existing statin-modifying therapy.

Being tested
Anacetrapib 100 mg, Placebo for anacetrapib 100 mg, Anacetrapib 25 mg, Placebo for anacetrapib 25 mg
Medical subject headings
Hypercholesterolemia

What participants receive

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

  • Anacetrapib 100 mgDrug

    Also called MK-0859

    100 mg tablet, oral, once daily for 24 weeks

  • Placebo for anacetrapib 100 mgDrug

    Placebo tablet, orally, once daily for 24 weeks

  • Anacetrapib 25 mgDrug

    Also called MK-0859

    25 mg tablet, oral, once daily for 24 weeks

  • Placebo for anacetrapib 25 mgDrug

    Placebo tablet, orally, once daily for 24 weeks

Study groups in NCT01717300
Study groupRoleWhat they receive
Anacetrapib 100 mgExperimentalNot described
Receives: Drug: Anacetrapib 100 mg; Drug: Placebo for anacetrapib 25 mg
Anacetrapib 25 mgExperimentalNot described
Receives: Drug: Placebo for anacetrapib 100 mg; Drug: Anacetrapib 25 mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo for anacetrapib 100 mg; Drug: Placebo for anacetrapib 25 mg

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 24

  2. Percent Change from Baseline in HDL-C

    Measured: Baseline and Week 24

  3. Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3xULN (Upper Limit of Normal)

    Measured: 24 Weeks

  4. Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms

    Measured: 24 weeks

  5. Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <LLN (Lower Limit of Normal)

    Measured: 24 weeks

  6. Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause

    Measured: 24 weeks

  7. Number of Participants with Significant Increase in Blood Pressure

    Measured: 24 weeks

Secondary outcomes (5)

  1. Percent change from Baseline in non-HDL-C

    Measured: Baseline and Week 24

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

    Measured: Baseline and Week 24

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

    Measured: Baseline and Week 24

  4. Percent Change from Baseline in Lipoprotein(a) (lp[a])

    Measured: Baseline and Week 24

  5. Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C goal

    Measured: Baseline and Week 24

Timeline

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

  1. First posted30 Oct 2012 (estimated)
  2. Study start6 Nov 2012
  3. Primary completion29 Oct 2014
  4. Study completion29 Oct 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
459 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01717300
Sponsor's protocol ID
0859-021
Other IDs
2012-003110-14
Status last verified
Apr 2017
First submitted
26 Oct 2012
Last updated
17 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Ballantyne CM, Shah S, Kher U, Hunter JA, Gill GG, Cressman MD, Ashraf TB, Johnson-Levonas AO, Mitchel YB. Lipid-Modifying Efficacy and Tolerability of Anacetrapib Added to Ongoing Statin Therapy in Patients with Hypercholesterolemia or Low High-Density Lipoprotein Cholesterol. Am J Cardiol. 2017 Feb 1;119(3):388-396. doi: 10.1016/j.amjcard.2016.10.032. Epub 2016 Nov 1.

    PubMed 27956003

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anacetrapib 100 mg and Anacetrapib 25 mg in people with Hypercholesterolemia, 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 3 inclusion and 16 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 17 Apr 2017. 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 24). The study lists 7 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 NCT01717300, 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 17 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in