Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01841684
First received: April 24, 2013
Last updated: February 17, 2014
Last verified: February 2014

April 24, 2013
February 17, 2014
June 2013
June 2014   (final data collection date for primary outcome measure)
  • Percent change from Baseline in Low-density Lipoprotein-Cholesterol (LDL-C) using beta-quantification method [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3x Upper Limit of Normal (ULN) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <Lower Limit of Normal (LLN) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants with Significant Increase in Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01841684 on ClinicalTrials.gov Archive Site
  • Percent Change from Baseline in High-density Lipoprotein-cholesterol (HDL-C) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Apolipoprotein A-I (apoA-I) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)
A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Lipid-Lowering Therapy in Adult Patients With Homozygous Familial Hypercholesterolemia (HoFH)

This study will evaluate the safety and effect of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) when added to ongoing lipid-lowering therapy. The primary hypothesis is that treatment with anacetrapib 100 mg for 12 weeks will lower LDL-C to a greater extent than treatment with placebo.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Hyperlipoproteinemia Type II
  • Homozygous Familial Hypercholesterolemia
  • Drug: Anacetrapib
    100 mg tablet orally, once daily for 12 weeks
    Other Name: MK-0859
  • Drug: Placebo
    Placebo for anacetrapib orally, once daily for 12 weeks
  • Experimental: Anacetrapib
    Participants receive anacetrapib 100 mg orally once daily for 12 weeks.
    Intervention: Drug: Anacetrapib
  • Placebo Comparator: Placebo
    Participants receive placebo orally once daily for 12 weeks.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with HoFH by genotyping
  • If female, cannot be of reproductive potential
  • Have been stabilized on statin monotherapy or statin therapy coadministered

with other lipid medications for at least 6 weeks

Exclusion Criteria:

  • Severe chronic heart failure defined by New York Heart Association

(NYHA) Classes III or IV

  • Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary arterial by-pass graft (CABG), unstable angina or stroke within 3 months prior to Visit 1 or has planned procedures scheduled within first 12 weeks of study
  • Uncontrolled endocrine or metabolic disease known to influence serum

lipids or lipoproteins

  • Active or chronic hepatobiliary or gall bladder disease
  • History of ileal bypass, gastric bypass, or other significant condition

associated with malabsorption

  • Human immunodeficiency virus (HIV) positive
  • 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
  • Taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A4), 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. Consumption of >1 liter of grapefruit juice per day is also prohibited.
  • Currently participating or has participated in a study with an investigational compound or device within 3 months
  • Consume more than 2 alcoholic drinks per day
  • Receiving treatment with systemic corticosteroids or systemic anabolic agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01841684
0859-042, 2012-002434-37
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP