Source: isrctn - Le promoteur: Servier Deutschland GmbH (Germany)

Triveram in patients with hypertension and concomitant primary hypercholesterolemia or mixed hyperlipidemia Background and study aims Cardiovascular (heart) diseases present are the most frequent reason for premature death, accounting for almost 4 million deaths in Europe per year. High blood pressure (hypertension) and high levels of blood lipids (fats) are two of the most commonly co-occurring cardiovascular risk factors. More than 64% of patients with high blood pressure also have high blood fat levels, and conversely, almost 47% of patients with high blood fat also have high blood pressure. These two factors together cause an accelerated damage to blood vessels. Treatment with a combination of the blood pressure lowering drugs perindopril and amlodipine with a lipid-lowering agent atorvastatin has been found to better protect against cardiovascular events such as heart attacks compared to a similar combination of betablocker, diuretic and atorvastatin. Triveram® is a combination of the above mentioned agents, atorvastatin, perindopril and amlodipine, in a single tablet. It is used to treat high blood pressure and/or stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) in adults who also suffer from elevated cholesterol levels (primary hypercholesterolemia) or elevated cholesterol and fat (triglyceride) levels at the same time (combined or mixed hyperlipidemia). Triveram® is intended for patients already on treatment with atorvastatin, perindopril and amlodipine as single tablets. The aim of this study is to gather information on the use of Triveram® in adult outpatients suffering the above mentioned diseases in daily practice, with a focus on changes in blood pressure, lipid parameters and other treatments, as well as treatment adherence, pill burden and treatment satisfaction. Who can participate? Adult outpatients with arterial hypertension and elevated cholesterol levels or elevated cholesterol and fat levels at the same time. What does the study involve? All patients involved in the study are treated with Triveram® under the circumstance that the decision about the treatment was made before the start of the study. The patients are asked to come to two follow-up visits after 1 and 4 months. During these visits a routine practice investigation is carried out and a form will be filled out by the treating physician regarding blood pressure, blood lipids (fats), and other diseases and medications. The patients are asked to fill out the patient questionnaire about treatment adherence, pill burden and treatment satisfaction at the first and the last visit. What are the possible benefits and risks of participating? There are no particular benefits or risks of participating in this study. The treatment given to the patient is the standard medical routine treatment and is completely independent of the study. Patients are free to withdraw from the study at any time without giving a particular reason. Where is the study run from? It is planned that the study will be carried out by about 700 general practitioners and cardiologists across Germany. There is no lead center. When is the study starting and how long is it expected to run for? April 2016 to May 2017 Who is funding the study? Servier Deutschland GmbH (Germany) Who is the main contact? Dr Peter Martinka

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