A Multicenter, Randomized, Double-Blind, Parallel Group, 12-Week Study to Evaluate the Efficacy and Safety of Extended-Release (ER) Niacin/Laropiprant Added to Statin Versus Doubling the Dose of Statin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia. - Extended Release Niacin/Laropiprant – Lipids

• Conditions: Hypercholesterolemia or Mixed Dyslipidemia; MedDRA version: 9.1Level: LLTClassification code 10020604Term: Hypercholesterolemia

• Registration Number: EUCTR2007-002017-39-CZ
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

1. All patients must have their LDL-C value above their goal (based on NCEP ATP III Guidelines) when on a stable dose of statin defined by the protocol:
•Patient is high risk (CHD/CHD risk equivalent including diabetes) with an LDL-C >100 mg/dL and =130 mg/dL (2.7 mmol/L and 3.4 mmol/L).
•Patient has multiple risk factors (=2 RF) with an LDL-C >130 mg/dL and =160 mg/dL (3.4 mmol/L and 4.1 mmol/L).
•Patient is low risk (0 to 1 RF) with an LDL-C >160 mg/dL and =190 mg/dL (4.1 mmol/L and 5.0 mmol/L).
2. Patient with diabetes mellitus must have a confirmed diagnosis and been on a stable dose of antidiabetic pharmacotherapy for 3 months prior to the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient has a history of hypersensitivity or allergic reaction to niacin or niacin-containing products, simvastatin, or atorvastatin.
2. Patient has uncontrolled/unstable cardiac arrhythmias, or unstable hypertension
3. Patient has taken torcetrapib alone or in combination and the last dose was within 1 year of Visit 1.
4. Patient has the following exclusionary laboratory values at Visit 1.
•Creatinine >2.0 mg/dL (177 micromol/L)
•ALT (SGPT) >1.5 x ULN
•AST (SGOT) >1.5 x ULN
•CK >2 x ULN

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified