Condition category
Circulatory System
Date applied
11/04/2016
Date assigned
30/06/2016
Last edited
28/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Martinka

ORCID ID

Contact details

Servier Deutschland GmbH
Elsenheimerstr. 53
München
80687
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IC4-05153-179-DEU

Study information

Scientific title

TRIVERAM-PRACTICE: an open, multi-center, single-arm, non-interventional, observational study in hypertensive outpatients with concomitant primary hypercholesterolemia or mixed hyperlipidemia treated with Triveram in Germany

Acronym

TRIVERAM-PRACTICE

Study hypothesis

In previous clinical studies the free combination of Perindopril, Amlodipine and Atorvastatin showed good efficacy in treatment of patients with essential hypertension and concomitant hypercholesterolemia. Data are lacking on the practical use of a new fixed-dose combination of atorvastatin, perindopril and amlodipine - Triveram® - in daily practice in patients with hypertension and concomitant primary hypercholesterolemia or mixed hyperlipidemia.

Ethics approval

Freiburg Ethics Committee International, 29/02/2016, ref: 016/1161

Study design

Prospective open multicenter single-arm observational non-interventional study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Essential hypertension with concomitant primary hypercholesterolemia or mixed hyperlipidemia

Intervention

This is strictly a non-interventional observational study. Only interventions in line with and not exceeding the standard medical routine are allowed. All patients involved in the study will be treated with Viacoram® under the circumstance that the decision about the treatment was done prior to the study initiation. After the inclusion the patients will be asked to come to two follow-up visits after 1 and 4 months. During these visits a routine practice investigation will be carried out and a case report form regarding blood pressure, lipid parameters, concomitant diseases and co-medications will be filled out by the treating physician. The patients will be asked to fill out the patient questionnaire to therapy adherence, pill burden and therapy satisfaction at the first and the last visit.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Office blood pressure and lipid parameters measured within the daily medical routine at inclusion, after approx. 1 month and at study final examination after approx. 4 months.

Secondary outcome measures

1. Ambulatory blood pressure monitoring only in measured as part of the medical routine at inclusion, after approx. 1 month and at study final examination after approx. 4 months
2. Home blood pressure at inclusion, after approx. 1 month and at study final examination after approx. 4 months
3. Assessment of therapy adherence measured by means of the Hill-Bone-Scale at inclusion and at study final examination after approx. 4 months
4. Assessment of pill burden and therapy satisfaction at inclusion and at study final examination after approx. 4 months

Overall trial start date

04/04/2016

Overall trial end date

31/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients with essential hypertension and concomitant hypercholesterolemia or mixed hyperlipidemia eligible for the treatment with Triveram® in line with the marketing authorization for whom the treatment decision was done prior to study inclusion.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1350

Participant exclusion criteria

N/A

Recruitment start date

04/04/2016

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Germany

Trial participating centre

700 cardiologists and general practicioners
-
Germany

Sponsor information

Organisation

Servier Deutschland GmbH (Germany)

Sponsor details

Elsenheimerstr. 53
München
80687
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Servier Deutschland GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The whole study report including all results will be published according to the German drug act on the website of the German regulatory authority (BfArM) within one year after completion of the study. An abstract will be submitted to the Congress of the German Hypertension League in December 2017. This will contain the main results regarding the blood pressure, blood lipids as well as patient adherence, pill burden and treatment satisfaction data.

Intention to publish date

01/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes