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. Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, de 12 semanas para evaluar la eficacia y la seguridad de niacina de liberación prolongada (LP)/laropiprant añadidos a una estatina en comparación con la duplicación de la dosis de la estatina en pacientes con hipercolesterolemia primaria o dislipidemia mixta - Extended Release Niacin/Laropiprant – Lipids

Phase 1

• Conditions: Hypercholesterolemia or Mixed Dyslipidemia Hipercolesterolemia o dislipidemia mixta; MedDRA version: 9.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia

• Registration Number: EUCTR2007-002017-39-ES
• Lead Sponsor: Merck Sharp & Dohme de España, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-10-10
• Study Start: 2010-03-09
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary end point is the percent change from baseline in LDL-C at Week 12. The baseline is defined as Day 1 (randomization visit) measurement.;Main Objective: To evaluate the LDL-C lowering efficacy of the addition of ER niacin/laropiprant to simvastatin or atorvastatin (pooled) compared with doubling the dose of simvastatin or atorvastatin (pooled) in patients with primary hypercholesterolemia or mixed dyslipidemia who are not at their NCEP ATP III LDL-C goal.;Secondary Objective: To evaluate other lipid efficacy of the addition of ER niacin/laropiprant to simvastatin or atorvastatin (pooled) compared with doubling the dose of simvastatin or atorvastatin (pooled) in patients with primary hypercholesterolemia or mixed dyslipidemia who are not at their NCEP ATP III LDL-C goal.