Clinical trial NCT00479882: MK-0524B Lipid Study (MK-0524B-063)
Official title: A Multicenter, Randomized, Double-Blind, "Crossover" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet Compared to MK-0524A + Simvastatin Coadministration in Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Mixed Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 2414
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on lipid values.


Eligibility criteria: Inclusion Criteria:

* has primary hypercholesterolemia or mixed dyslipidemia based on medical history (previous diagnosis), historic lipid values, or as otherwise determined through optional lipid measurements at screening visit
* meets one of the following triglyceride (TG) criteria:

  1. is on niacin, statin, or fibrate and has TG \<500 mg/dL at or within 6 months of washout
  2. is not on any lipid altering therapy or is on lipid altering therapy other than niacin, statin, or fibrate and has TG \<600 mg/dL at or within 6 months of screening

Exclusion Criteria:

* is high risk (coronary heart disease \[CHD\] or CHD risk equivalent) AND is on a statin
* is pregnant or breast-feeding, or expecting to conceive during the study including the 14-day post study follow-up
* has Type 1 or Type 2 diabetes mellitus and is on statin therapy, is poorly controlled, is newly diagnosed (within 3 months of Visit 1), has recently experienced repeated hypoglycemia or unstable glycemic control or is taking new or recently adjusted anti-diabetic medications (with the exception of +/- 10 units of insulin) within 3 months of Visit 1
* has the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, human immunodeficiency virus (HIV) positive, gout (within 1 year)

Primary outcomes:
measure: Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)
Secondary outcomes:
measure: Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)
measure: Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage of Participants With Creatine Kinase (CK) >=10 x ULN
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage of Participants With CK >=10 x ULN With Muscle Symptoms
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage of Participants With New Diagnosis of Diabetes
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage of Participants Who Experience at Least 1 Laboratory AE
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage of Participants Who Experience at Least 1 Hepatitis-related Non-serious Clinical AE
timeFrame: up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
measure: Percentage Change From Baseline in LDL-C at Week 4
timeFrame: Baseline (Day1 of Period I) and Week 4
measure: Percentage Change From Baseline in HDL-C at Week 4
timeFrame: Baseline (Day1 of Period I) and Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: