Lipid Efficacy/Tolerability Study (0524A-020)

NCT00269204 | Completed Phase 3

• 3 other identifiers: 0524A-020MK0524A-0202005_095
• Study Type: interventional
• Target: 1,620
• Locations: 0 countries
• Sites: N/A

Brief Summary

A 28-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9 scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of the 3 treatment groups.

Conditions

Primary Hypercholesterolaemia; Mixed Hyperlipidaemia

Outcome Measures

Primary Outcomes (1)

• Reductions of LDL-C concentrations at 24 weeks and better tolerability

  at 24 weeks

Secondary Outcomes (1)

• Elevations in HDL-C concentrations at 24 weeks

  at 24 weeks

Interventions

niacin (+) laropiprant DRUG

Duration of Treatment - 24 weeks

Also known as: MK0524A

ER-niacin DRUG

Duration of Treatment - 24 weeks

Eligibility Criteria

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

You may qualify if:

• Patients 18 to 85 years of age with Primary Hypercholesterolemia or Mixed Hyperlipidemia with LDL-C below 100 mg/dL for high risk patients (patients with Coronary Artery Disease (CHD).
• Have medical conditions considered to be CHD equivalent).
• LDL-C below 130 mg/dL for patients with multiple risk factors.
• LDL-C between 130 and 190 mg/dL for patients with low risk and Triglycerides \</= to 350 mg/dL.

You may not qualify if:

• A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study, patients \< 20% compliance, patients with chronic medical conditions, patients with unstable doses of medications.
• Pregnant or lactating women, or women intending to become pregnant are excluded.
• Patient with diabetes mellitus that is poorly controlled, newly diagnosed, has recently experienced repeated hypoglycemia or unstable glycemic control, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin).
• Patients with the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, gout (within 1 year).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (6)

• Baron JA, Sandler RS, Bresalier RS, Quan H, Riddell R, Lanas A, Bolognese JA, Oxenius B, Horgan K, Loftus S, Morton DG; APPROVe Trial Investigators. A randomized trial of rofecoxib for the chemoprevention of colorectal adenomas. Gastroenterology. 2006 Dec;131(6):1674-82. doi: 10.1053/j.gastro.2006.08.079. Epub 2006 Sep 1.

  PMID: 17087947 BACKGROUND

• Maccubbin D, Bays HE, Olsson AG, Elinoff V, Elis A, Mitchel Y, Sirah W, Betteridge A, Reyes R, Yu Q, Kuznetsova O, Sisk CM, Pasternak RC, Paolini JF. Lipid-modifying efficacy and tolerability of extended-release niacin/laropiprant in patients with primary hypercholesterolaemia or mixed dyslipidaemia. Int J Clin Pract. 2008 Dec;62(12):1959-70. doi: 10.1111/j.1742-1241.2008.01938.x.

  PMID: 19166443 BACKGROUND

• Bays HE, Maccubbin D, Meehan AG, Kuznetsova O, Mitchel YB, Paolini JF. Blood pressure-lowering effects of extended-release niacin alone and extended-release niacin/laropiprant combination: a post hoc analysis of a 24-week, placebo-controlled trial in dyslipidemic patients. Clin Ther. 2009 Jan;31(1):115-22. doi: 10.1016/j.clinthera.2009.01.010.

  PMID: 19243712 BACKGROUND

• Rao M, Steffes M, Bostom A, Ix JH. Effect of niacin on FGF23 concentration in chronic kidney disease. Am J Nephrol. 2014;39(6):484-90. doi: 10.1159/000362424. Epub 2014 May 20.

  PMID: 24854458 DERIVED

• Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000.

  PMID: 22500948 DERIVED

• Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45. doi: 10.1111/j.1742-1241.2010.02620.x.

  PMID: 21401833 DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

Niacin; MK-0524

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)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

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: December 21, 2005
• First Posted: December 23, 2005
• Study Start: December 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 27, 2015

Record last verified: 2015-07