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)
Sponsor:
Daniel A. Siniawski
Collaborator:
Merck
Information provided by (Responsible Party):
Daniel A. Siniawski, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01308203
First received: March 3, 2011
Last updated: January 24, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
- 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
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease Dyslipidemias |
Drug: Extended release niacin/laropiprant Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| 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:
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).
| Enrollment: | 32 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
Drug: placebo
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.
|
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Daniel A. Siniawski, Associated Medical Doctor, Hospital Italiano de Buenos Aires |
| ClinicalTrials.gov Identifier: | NCT01308203 History of Changes |
| Other Study ID Numbers: | 1608 |
| Study First Received: | March 3, 2011 |
| Last Updated: | January 24, 2013 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Dyslipidemias Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Lipid Metabolism Disorders Metabolic Diseases Niacin Nicotinic Acids Niacinamide |
Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013