TerminatedPhase 4

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

Stopped: Merck has decided to discontinue all studies with extended-release niacin/laropiprant.because the HPS2-THRIVE did not meet its primary endpoint

Argentina32 participantsStarted 2011-10

Plain-language 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

Who can participate

Age range21 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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.

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

Trial details

NCT IDNCT01308203

SponsorDaniel A. Siniawski

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-01