Lipid Efficacy of the Extended Release Niacin/Laropiprant Combination in Patients With Cardiovasc… (NCT01308203) | Clinical Trial Compass
TerminatedPhase 4
Lipid Efficacy of the Extended Release Niacin/Laropiprant Combination in Patients With Cardiovascular Disease
Stopped: Merck has decided to discontinue all studies with extended-release niacin/laropiprant.because the HPS2-THRIVE did not meet its primary endpoint
Argentina32 participantsStarted 2011-10
Plain-language 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
Who can participate
Age range
21 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.