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

Information source: Hospital Italiano de Buenos Aires
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease; Dyslipidemias

Intervention: Extended release niacin/laropiprant (Drug); placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Daniel A. Siniawski

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

Clinical Details

Official title: Lipid Efficacy and Effects on HDL-C Metabolism of the Extended Release Niacin/Laropiprant Combination Added to Usual Therapy in Patients With Cardiovascular Disease and Low HDL-C That Did Not Achieve the Optional Very Low LDL-C Goal

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: 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)].

Detailed description: During the screening period, patients will be pre-selected from medical records of patients that met the inclusion criteria. Patients who fulfilled the eligibility criteria will be invited to participate in the study by signing the consent form. After consenting, a screening blood sample test will be taken to determine TC, HDL-C, TG, LDL-C, non-HDL-C (the difference between TC and HDL-C), ALT, AST, CK, hemoglobin A1c (HbA1c), uric acid and TSH in the local laboratory. Patients who have HDL-C, LDL-C and/or non-HDL-C within inclusion criteria and had none of the biochemical exclusion criteria will be randomized one week after the screening blood test. Further blood samples will be obtained at baseline, 4 weeks (± 2 days), 12 weeks (± 2 days), 16 weeks (± 2 days) and 24 weeks (± 2 days). The blood samples will be centrifuged a 2000 rpm and a tube with blood serum will be sent to the local laboratory for measuring plasma levels of TC, HDL-C, TG, LDL-C, ALT, AST, CK, fasting glucose, HbA1c, creatinine, uric acid, ApoB, ApoA, Lp(a), high sensibility-C Reactive Protein (hs-CRP) and HDL-C sub-fractions (baseline, weeks 12 and 24). ALT, AST, CK, fasting glucose, creatinine and uric acid will be measured at weeks 4 and 16. A second tube will be

frozen in - 70ºC refrigerator an will be sent to the Department of Clinical Biochemistry of

the Faculty of Pharmacy and Biochemistry from the University of Buenos Aires (Argentina) to determine: paraoxonase 1/arylesterase activity (PON1), soluble cell adhesion molecule level (ICAM-1), tumor necrosis factor-α (TNF-α), lipoprotein-associated phospholipase A2 (Lp-PLA2) and cholesterol ester transfer protein (CETP) activity. A third tube will be frozen in

- 70ºC refrigerator an will be sent to the Cardiovascular Research Center of the Faculty of

Medical Sciences from the University of La Plata (Argentina) to determine ex vivo cellular cholesterol efflux capacity. A unique patient number will be provided by the randomization coordinating centre from the Hospital Italiano de Buenos Aires. Randomized patient will received a bottle of 35 pills with 1g ERN/20mg LRPT or placebo. 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 four bottles of 35 pills with 1g ERN/20mg LRPT or placebo. At week 12 (± 2 days), patients will be assessed in the outpatient clinic patients and will be crossed over to placebo or active medication. Patients will receive a bottle of 35 pills with 1g ERN/20mg LRPT or placebo. At week 16 (± 2 days), patients with good tolerance to the study medication will receive four bottles of 35 pills with 1g ERN/20mg LRPT or placebo.

Eligibility

Minimum age: 21 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Locations and Contacts

Hospital Italiano de Buenos Aires, Buenos Aires C1181ACH, Argentina
Additional Information

Starting date: October 2011
Last updated: August 17, 2015

Page last updated: August 23, 2015

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