MK-0524B Lipid Study (MK-0524B-063)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Mixed Dyslipidemia; Primary Hypercholesterolemia

Treatments: Drug: MK-0524B; Drug: Placebo; Drug: MK-0524A; Drug: Comparator: simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479882

MK-0524B-063 (Other Identifier)

0524B-063

2007_504

Details and patient eligibility

About

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.

Enrollment: 2,414 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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2,414 participants in 4 patient groups

Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg

Experimental group

Description:

After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.

Treatment:

Drug: MK-0524B

Drug: Comparator: simvastatin

Drug: Placebo

Drug: MK-0524A

Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg

Experimental group

Description:

After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.

Treatment:

Drug: MK-0524B

Drug: Comparator: simvastatin

Drug: Placebo

Drug: MK-0524A

Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg

Experimental group

Description:

After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.

Treatment:

Drug: MK-0524B

Drug: Comparator: simvastatin

Drug: Placebo

Drug: MK-0524A

Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg

Experimental group

Description:

After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.

Treatment:

Drug: MK-0524B

Drug: Comparator: simvastatin

Drug: Placebo

Drug: MK-0524A