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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01717300
First received: October 26, 2012
Last updated: February 13, 2014
Last verified: February 2014

October 26, 2012
February 13, 2014
November 2012
November 2014   (final data collection date for primary outcome measure)
  • Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in HDL-C [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3xULN (Upper Limit of Normal) [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <LLN (Lower Limit of Normal) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants with Significant Increase in Blood Pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01717300 on ClinicalTrials.gov Archive Site
  • Percent change from Baseline in non-HDL-C [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Apolipoprotein B (Apo-B) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in Lipoprotein(a) (lp[a]) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C goal [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy (MK-0859-021)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: Anacetrapib 100 mg
    100 mg tablet, oral, once daily for 24 weeks
    Other Name: MK-0859
  • Drug: Placebo for anacetrapib 100 mg
    Placebo tablet, orally, once daily for 24 weeks
  • Drug: Anacetrapib 25 mg
    25 mg tablet, oral, once daily for 24 weeks
    Other Name: MK-0859
  • Drug: Placebo for anacetrapib 25 mg
    Placebo tablet, orally, once daily for 24 weeks
  • Experimental: Anacetrapib 100 mg
    Interventions:
    • Drug: Anacetrapib 100 mg
    • Drug: Placebo for anacetrapib 25 mg
  • Experimental: Anacetrapib 25 mg
    Interventions:
    • Drug: Placebo for anacetrapib 100 mg
    • Drug: Anacetrapib 25 mg
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo for anacetrapib 100 mg
    • Drug: Placebo for anacetrapib 25 mg
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
450
February 2015
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01717300
0859-021, 2012-003110-14
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