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

NCT00479882 | Completed Phase 3 Results

• 3 other identifiers: 0524B-063MK-0524B-0632007_504
• Study Type: interventional
• Target: 2,414
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Hypercholesterolemia; Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

  Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.

  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 (16)

• Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)

  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)

• Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)

  up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

• Percentage of Participants With Creatine Kinase (CK) >=10 x ULN

  up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

• Percentage of Participants With CK >=10 x ULN With Muscle Symptoms

  up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

• Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related

  up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)

Study Arms (4)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

Comparator: simvastatin DRUG

Also known as: Zocor®, MK0733

Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg; Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg; Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg; Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg

MK-0524A DRUG

Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet

Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg; Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg; Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg; Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg

Placebo DRUG

Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg; Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg; Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg; Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg

MK-0524B DRUG

Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg; Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg; Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg; Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• is on niacin, statin, or fibrate and has TG \<500 mg/dL at or within 6 months of washout
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Interventions

Simvastatin

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 28, 2007
• Study Start: June 15, 2007
• Primary Completion: June 16, 2008
• Study Completion: June 16, 2008
• Last Updated: February 6, 2019
• Results First Posted: April 1, 2016

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share