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A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy (MK-0859-021)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01717300
First received: October 26, 2012
Last updated: April 13, 2017
Last verified: April 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Hypercholesterolemia | Drug: Anacetrapib 100 mg Drug: Placebo for anacetrapib 100 mg Drug: Anacetrapib 25 mg Drug: Placebo for anacetrapib 25 mg | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) [ Time Frame: Baseline and Week 24 ]
- Percent Change from Baseline in HDL-C [ Time Frame: Baseline and Week 24 ]
- Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3xULN (Upper Limit of Normal) [ Time Frame: 24 Weeks ]
- Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms [ Time Frame: 24 weeks ]
- Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <LLN (Lower Limit of Normal) [ Time Frame: 24 weeks ]
- Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause [ Time Frame: 24 weeks ]
- Number of Participants with Significant Increase in Blood Pressure [ Time Frame: 24 weeks ]
Secondary Outcome Measures:
- Percent change from Baseline in non-HDL-C [ Time Frame: Baseline and Week 24 ]
- Percent Change from Baseline in Apolipoprotein B (Apo-B) [ Time Frame: Baseline and Week 24 ]
- Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) [ Time Frame: Baseline and Week 24 ]
- Percent Change from Baseline in Lipoprotein(a) (lp[a]) [ Time Frame: Baseline and Week 24 ]
- Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C goal [ Time Frame: Baseline and Week 24 ]
| Enrollment: | 459 |
| Actual Study Start Date: | November 6, 2012 |
| Study Completion Date: | October 29, 2014 |
| Primary Completion Date: | October 29, 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Anacetrapib 100 mg |
Drug: Anacetrapib 100 mg
100 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 25 mg |
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
|
| Placebo Comparator: Placebo |
Drug: Placebo for anacetrapib 100 mg
Placebo tablet, orally, once daily for 24 weeks
Drug: Placebo for anacetrapib 25 mg
Placebo tablet, orally, once daily for 24 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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More Information
Publications:
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT01717300 History of Changes |
| Other Study ID Numbers: |
0859-021 2012-003110-14 ( EudraCT Number ) |
| Study First Received: | October 26, 2012 |
| Last Updated: | April 13, 2017 |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Anacetrapib Oxazolidinones Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on July 21, 2017