Condition category
Circulatory System
Date applied
11/09/2015
Date assigned
28/10/2015
Last edited
02/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Arterial hypertension (high blood pressure) can cause premature death. In Germany, about 30% of women and 33% of men aged between 18-79 have hypertension. In adults aged between 70-79, some 75% of people of both sexes have the condition. Based on the public importance of the disease, a timely return to a normal blood pressure should always be the aim. If the recommended initial non-pharmacological (drug) measures (for example, lifestyle changes) are not successful, a drug treatment should be started. Viacoram® is a single-pill combination of two drugs, amlodipine and perindopril, both used for treatment of arterial hypertension. It is used for the treatment of adult patients with arterial hypertension. The aim of this observational study is to gain information on the use of Viacoram® in outpatients with hypertension. This study will focus on the change of the blood pressure, time to achieve normal blood pressure, change in other treatments the patients may be taking as well as whether they keep taking the drug (therapy adherence) and an assessment of general tolerability.

Who can participate?
Adult outpatients with arterial hypertension that have been recommended treatment with Viacoram®.

What does the study involve?
All patients in the trial involved in the study are treated with Viacoram®. They are asked to come to three follow up visits after 1, 2 and 3 months. During these visits a routine practice investigation is carried out and a case report form regarding blood pressure, other diseases the patient is suffering from and what other medications they are taking is filled out by the treating physician. The patients are asked to fill out the patient questionnaire to therapy adherence at the first and the last visit.

What are the possible benefits and risks of participating?
The patients have no particular benefits or risks of participating in this observational study. The treatment given to the patient corresponds to the standard medical routine and is completely independent of the study as the study is strictly non-interventional. Patients are free to withdraw from the study at any time without giving a particular reason.

Where is the study run from?
Study will be carried out by approximately 1000 general practitioners across Germany.

When is study starting and how long is it expected to run for?
September 2015 to April 2016

Who is funding the study?
Servier Deutschland, GmbH (Germany)

Trial website

Contact information

Type

Public

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

IC4-05985-161-DEU

Study information

Scientific title

Viacoram® - focus on blood pressure target. An open single-arm non-interventional observational study in hypertensive outpatients treated with Viacoram® in Germany.

Acronym

VIACORAM-BPT

Study hypothesis

Aim of this non-interventional study is to gain information on the use of Viacoram® in hypertensive outpatients in line with the marketing authorization under the conditions of daily practice in Germany. Special focus of the study is the change in the blood pressure (office, ABPM, central BP parameters), time to achieve the BP target, change in the concomitant treatments and therapy adherence as well as assessment of general tolerability.

Ethics approval

Freiburg Ethics Committee International ("Freiburger Ethik Komission Internation), 27/07/2015, ref: 015/1441

Study design

Prospective, open, multicentre, 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 contact details to request a participant information sheet

Condition

Essential hypertension

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 three follow up visits after 1, 2 and 3 months. During these visits a routine practice investigation will be carried out and a case report form regarding blood pressure, 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 at the first and the last visit.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Office blood pressure measured within the daily medical routine at inclusion, after approx. 1 month, 2 months and at study final examination after approx. 3 months.

Secondary outcome measures

1. Ambulatory BP monitoring only in measured as part of the medical routine at inclusion, after approx. 1 month, 2 months and at study final examination after approx. 3 months
2. Central BP parameters only in measured as part of the medical routine at inclusion, after approx. 1 month, 2 months and at study final examination after approx. 3 months
3. Assessment of therapy adherence measured by means of the Hill-Bone-Scale

Overall trial start date

21/09/2015

Overall trial end date

30/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients with essential hypertension with currently not controlled blood pressure eligible for the treatment with Viacoram® for whom the treatment decision was done prior to study inclusion.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3000

Participant exclusion criteria

N/A

Recruitment start date

21/09/2015

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Germany

Trial participating centre

General practitioners
-
Germany

Sponsor information

Organisation

Servier Deutschland GmbH

Sponsor details

Elsenheimerstr. 53
München
80687
Germany

Sponsor type

Industry

Website

www.servier.de

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 2016. This will contain the main results regarding the BP decrease and time to achieve BP goal as well as patient compliance data.

Intention to publish date

30/04/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes