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

• Status: Terminated
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel A. Siniawski
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Niacin; Niacinamide; Nicotinic Acids

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.