Lipid Efficacy of the Extended Release Niacin/Laropiprant Combination in Patients With Cardiovascular Disease
This study has been terminated.
(Merck has decided to discontinue all studies with extended-release niacin/laropiprant)
Daniel A. Siniawski
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Daniel A. Siniawski, Hospital Italiano de Buenos Aires
First received: March 3, 2011
Last updated: January 24, 2013
Last verified: January 2013
- 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
Coronary Artery Disease
Drug: Extended release niacin/laropiprant
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Hospital Italiano de Buenos Aires:
Primary Outcome Measures:
- 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. [ Time Frame: Week -1, baseline (week 0), week (12 ± 2 days) and week 24 (± 2days). ] [ Designated as safety issue: No ]Will be calculated by the Friedewald equation. With plasma triglycerides levels >400 mg/dL, LDL-C will be measured by an homogeneous method.
Secondary Outcome Measures:
- 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)]. [ Time Frame: Baseline (week 0), week 12 (± 2 days) and week (24 ± 2 days). ] [ Designated as safety issue: No ]TC: enzymatic method. HDL-C: homogeneous direct method. Lp(a),ApoA and ApoB: nephelometric method, using an Immage immunochemistry system (Beckman Coulter).
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Extended release niacin /laropiprant
The patients will be randomized to one of two arms. The intervention is with the extended release niacin laropiprant combination, that is an add on of the usual medication that the primary care physician gave them to treat their lipid disorder (statin, ezetimibe or the combination of both).
Drug: Extended release niacin/laropiprant
Randomized patient will received 1 tablet of 1g ERN/20 mg LRPT for the first 4 weeks of treatment. At week 4 (± 2 days)the patient will be assessed in the outpatient clinic. Patients with good tolerance to the study medication will receive 2 tablets of 1 g ERN/20 mg LRPT that should be taken together for the next 8 weeks. At week 12 (± 2 days), patients will be assessed in the outpatient clinic patients and will be crossed over to placebo.
Placebo Comparator: placebo
The patients will received placebo added to the usual therapy their primary care physician gave them to treat their lipid disorder (statin, ezetimibe or the combination of both).
Randomized patient will received 1 oral 1 g tablet of placebo for the first 4 weeks of treatment. 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 2 oral 1 g tablets of placebo that should be taken together for the next 8 weeks. At week 12 (± 2 days), patients will be assessed in the outpatient clinic patients and will be crossed over to active medication.
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