Lipid Efficacy of the Extended Release Niacin/Laropiprant Combination in Patients With Cardiovascular Disease

NCT01308203 | Terminated Phase 4

• 1 other identifier: 1608
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

• Clinical studies with statins have shown that patients that suffered a cardiovascular event have a high residual risk. Residual risk decreases with the attaining of progressive lower LDL-C levels.
• In patients treated with statins, HDL-C level is an independent inverse predictor of subsequent CV and coronary plaque progression, even when LDL-C levels are less than 70 mg/dL.
• Therefore the purpose on this study is to assess the lipid efficacy on lipid profile and effects on HDL-C metabolism and function of the extended release niacin/laropiprant combination added to usual therapy in very high risk patients with cardiovascular disease and low HDL-C that did not achieve the optional very low LDL-C or non-HDL-C goals

Conditions

Coronary Artery Disease; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Nominal change from baseline in low density lipoprotein- cholesterol (LDL-C) at 12 weeks of treatment with the extended release niacin /laropiprant combination added to usual therapy.

  Will be calculated by the Friedewald equation. With plasma triglycerides levels \>400 mg/dL, LDL-C will be measured by an homogeneous method.

  Week -1, baseline (week 0), week (12 ± 2 days) and week 24 (± 2days).

Secondary Outcomes (1)

• Efficacy on other lipid variables: high density lipoprotein-cholesterol (HDL-C), triglycerides, total cholesterol (TC), TC/HDL-C ratio, apolipoprotein B (ApoB), apolipoprotein A1 (ApoA), ApoB/ApoA ratio and lipoprotein (a) [Lp(a)].

  Baseline (week 0), week 12 (± 2 days) and week (24 ± 2 days).

Study Arms (2)

Extended release niacin /laropiprant

EXPERIMENTAL

The patients will be randomized to one of two arms. The intervention is with the extended release niacin laropiprant combination, that is an add on of the usual medication that the primary care physician gave them to treat their lipid disorder (statin, ezetimibe or the combination of both).

Drug: Extended release niacin/laropiprant

placebo

PLACEBO COMPARATOR

The patients will received placebo added to the usual therapy their primary care physician gave them to treat their lipid disorder (statin, ezetimibe or the combination of both).

Drug: placebo

Interventions

Extended release niacin/laropiprant DRUG

Randomized patient will received 1 tablet of 1g ERN/20 mg LRPT for the first 4 weeks of treatment. At week 4 (± 2 days)the patient will be assessed in the outpatient clinic. Patients with good tolerance to the study medication will receive 2 tablets of 1 g ERN/20 mg LRPT that should be taken together for the next 8 weeks. At week 12 (± 2 days), patients will be assessed in the outpatient clinic patients and will be crossed over to placebo.

Extended release niacin /laropiprant

placebo DRUG

Randomized patient will received 1 oral 1 g tablet of placebo for the first 4 weeks of treatment. At week 4 (± 2 days), after randomization the patient will be assessed in the outpatient clinic. Patients with good tolerance to the study medication will receive 2 oral 1 g tablets of placebo that should be taken together for the next 8 weeks. At week 12 (± 2 days), patients will be assessed in the outpatient clinic patients and will be crossed over to active medication.

placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men between 21 and 75 years old.
• Very high risk patients (according NCEP-ATP III definition) with coronary heart disease (CHD) or peripheral arterial disease (PAD), documented by an angiographic study.
• Clinical stability.
• Low HDL-C plasma levels: \< 40 mg/dL in men or \<50 mg/dL in women in the screening and lead-in blood sample tests.
• LDL-C plasma levels between 70-100 mg/dL or non-HDL-C between 100-130 mg/dL if TG were \> 200 mg/dL in the screening and lead-in blood sample tests.
• Statin based-treatment with or without ezetimibe in a stable dose in last 8 weeks.
• Women must be postmenopausal for at least 2 years and ≤ 75 years old.

You may not qualify if:

• Coronary event o arterial revascularization in the past 6 months.
• Uncontrolled diabetes mellitus (HbA1C \> 8%).
• Acute crisis, history of gout or uric acid \> 9 mg/dL.
• Thyroid stimulating hormone (TSH) outside the central laboratory's normal reference range.
• Renal insufficiency (creatinine \> 1.5 mg/dL).
• Baseline alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \> 1.5 UNL.
• Baseline creatine kinase (CK) \> 2 UNL.
• Triglycerides plasma level ≥ 500 mg/dL.
• Active fibrate therapy.
• Age \> 75 years old.

Sponsors & Collaborators

• Daniel A. Siniawski: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

MeSH Terms

Conditions

Coronary Artery Disease; Dyslipidemias

Interventions

MK-0524

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Medical Doctor

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 4, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

AR (1)