Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)

NCT00289900 | Completed Phase 3 Results

• 3 other identifiers: 0524B-024MK-0524B-0242005_103
• Study Type: interventional
• Target: 2,340
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to atorvastatin on decreasing the low denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg MK-0524B versus 80 mg atorvastatin.

Conditions

Mixed Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in the LDL-C/HDL-C Ratio

  Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.

  Baseline and Week 12

Secondary Outcomes (24)

• Percentage Change From Baseline in HDL-C

  Baseline and Week 12

• Percentage Change From Baseline in Triglycerides (TG)

  Baseline and Week 12

• Percentage Change From Baseline in Non-HDL-C

  Baseline and Week 12

• Percentage Change From Baseline in LDL-C

  Baseline and Week 12

• Percentage Change From Baseline in Apolipoprotein (Apo) B

  Baseline and Week 12

Study Arms (6)

MK-0524B 2g/20 mg

EXPERIMENTAL

Co-administration of one tablet of MK-0524A (Extended Release \[ER\] niacin/laropiprant \[LRPT\] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks

Drug: MK-0524A; Drug: Simvastatin

MK-0524B 2g/40mg

EXPERIMENTAL

Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks

Drug: MK-0524A; Drug: Simvastatin

Atorvastatin 10 mg

ACTIVE COMPARATOR

Atorvastatin 10 mg, orally, once daily for 12 weeks

Drug: Atorvastatin

Atorvastatin 20 mg

ACTIVE COMPARATOR

Atorvastatin 20 mg, orally, once daily for 12 weeks

Drug: Atorvastatin

Atorvastatin 40 mg

ACTIVE COMPARATOR

Atorvastatin 40 mg, orally, once daily for 12 weeks

Drug: Atorvastatin

Atorvastatin 80 mg

ACTIVE COMPARATOR

Atorvastatin 80 mg, orally, once daily for 12 weeks

Drug: Atorvastatin

Interventions

MK-0524A DRUG

MK-0524B 2g/20 mg; MK-0524B 2g/40mg

Atorvastatin DRUG

Also known as: Lipitor

Atorvastatin 10 mg; Atorvastatin 20 mg; Atorvastatin 40 mg; Atorvastatin 80 mg

Simvastatin DRUG

Also known as: Zocor

MK-0524B 2g/20 mg; MK-0524B 2g/40mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant 18 to 80 years of age with Mixed Hyperlipidemia with LDL-C between 130 and 190 mg/dL and Triglycerides between 150 and 500 mg/dL

You may not qualify if:

• Pregnant or lactating women, or women intending to become pregnant
• Diabetes mellitus that is poorly controlled, newly diagnosed, or taking new or recently adjusted antidiabetic therapy (with the exception of ± 10 units of insulin)
• Human immunodeficiency virus (HIV) positive
• Any of the following within the past 3 months: heart attack, stoke, heart bypass surgery, unstable angina, angioplasty
• Active or chronic liver disease

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Chen F, Maccubbin D, Yan L, Sirah W, Chen E, Sisk CM, Davidson M, Blomqvist P, McKenney JM. Lipid-altering efficacy and safety profile of co-administered extended release niacin/laropiprant and simvastatin versus atorvastatin in patients with mixed hyperlipidemia. Int J Cardiol. 2013 Jul 15;167(1):225-31. doi: 10.1016/j.ijcard.2011.12.103. Epub 2012 Feb 4.

  PMID: 22305632 RESULT

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Atorvastatin; Simvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 10, 2006
• Study Start: January 24, 2006
• Primary Completion: August 6, 2010
• Study Completion: August 6, 2010
• Last Updated: August 31, 2018
• Results First Posted: January 26, 2016

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share