Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Hypertension (high blood pressure) is a long term medical condition in which the pressure in the arteries is higher than it should be. This puts increased strain on the heart which, if left untreated, can lead to increased risk of heart attack or stroke. Antihypertensive treatments, such as medications to reduce blood pressure, are effective at lowering blood pressure and therefore stroke risk. This study aims to look at the blood pressure of middle-aged and older patients with high blood pressure and to see if there is a link with stroke risk and whether they are taking blood-pressure controlling medication.

Who can participate?
Adults aged 50 and over (60 and over in Columbia) who have high blood pressure.

What does the study involve?
Participants are reviewed as part of their usual clinical care, and once selected to participate in the study, are asked to sign an informed consent form. They then attend a single clinic visit at which their medical history, personal information, information about any medication they are taking to lower blood pressure and their blood pressure is taken. This information is then used to calculate the 5-year and 10-year risk of stroke for each patient using the Stroke Riskometer™ application.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
The study is run from Serdia Pharmaceuticals Pvt. Ltd. (India) and takes place in 176 health centres in India, 10 in Malaysia and 32 in Columbia.

When is the study starting and how long is it expected to run for?
October 2015 to December 2016

Who is funding the study?
Servier International (France)

Who is the main contact?
Stéphane DUBOIS, Pharm.D.
(updated 07/08/2020, previously: Dr Harpreet Lhoste)

Trial website

Contact information



Primary contact

Miss Nathalie Barbet


Contact details

Global Medical Affairs - GMA Cardiology
35 rue Verdun
Suresnes Cedex

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

SYSTUP: Study evaluating uncontrolled SYSTolic blood pressUre in middle-aged and older Patients with hypertension, in relation to stroke risk and current antihypertensive treatment



Study hypothesis

The aim of this study is to assess the level of raised systolic blood pressure in an older population, and to correlate this with stroke risk and antihypertensive treatment.

Ethics approval

1. India: Lancelot Independent Ethics Committee, 23/12/2015
2. Malaysia: Medical Research Ethics Committee, 02/08/2017
3. Colombia: no Ethics approval required

Study design

Multi-centre multi-country cross-sectional study

Primary study design


Secondary study design

Cross sectional study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Hypertension (particularly a raised systolic blood pressure) and stroke risk


If a potential participant fulfills the inclusion criteria, the investigator will present the main objectives of this study to them and will provide them with an information sheet. If the patient agrees to the recording of completely anonymous medical data concerning themselves, they will sign the participant consent form and be included into the study. Participants attend a single study visit at which the following data will be recorded using the case report form:
1. Demographic data (age)
2. Blood pressure reading during the visit with confirmation that systolic blood pressure is raised (blood pressure should be measured via the ESH guidelines using an auscultatory or oscillometric semiautomatic sphygmomanometer; allow the patient to sit for 3-5 minutes before taking measurements, take blood pressure from each arm and use the arm with the higher value as the reference, document the highest of at least two BP measurements taken from the reference arm at least 1-2 mins apart whilst in the sitting position)
3. Stroke risk factors (ethnicity, waist and hip circumference, diabetes, smoking, previous cardiovascular disease, diet, alcohol, stress, family history of cardiovascular disease);
4. Stroke risk score using Stroke Riskometer™ , where possible (this can be downloaded from Google Play [Android] or App Store [Apple], further details on
5. Antihypertensive treatment taken at the time of visit

Intervention type



Drug names

Primary outcome measure

1. Systolic blood pressure is measured using an auscultatory or oscillometric semiautomatic sphygmomanometer at the study visit
2. Stroke risk is determined using Stroke Riskometer™ at the study visit
3. Antihypertensive use is determined through qualitative interviews at the study visit

Secondary outcome measures

No secondary outcomes

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Age ≥50 years* (*≥60 years in Columbia)
2. Confirmed (in medical records) diagnosis of hypertension
3. Elevated systolic blood pressure (≥ 140 mm Hg)

Participant type


Age group




Target number of participants

Participants = approx. 4242 total (3945 india, 208 Colombia, 89 Malaysia)

Participant exclusion criteria

Conditions that prevent participation in the study, such as the inability to complete the participant consent form.

Recruitment start date


Recruitment end date



Countries of recruitment

Colombia, India, Malaysia

Trial participating centre

Serdia Pharmaceuticals (India) Pvt. Ltd.
Serdia House off Dr. S. S. Rao Road, Parel
400 012

Trial participating centre

Laboratorios Servier de Colombia SAS
Edificio 98-28 Transversal 19A# 98-28 Bogotá

Trial participating centre

Servier Malaysia SDN. BHD.
Suite 1005, 10th Floor Wisma Hamzah-Kwong Hing
Kuala Lumpur

Sponsor information


Servier International

Sponsor details

50 rue Carnot
Ile de France

Sponsor type




Funder type


Funder name

Servier International

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration.

Intention to publish date


Participant level data

Not expected to be available

Basic results (scientific)

See additional files (ISRCTN95532888_BasicResults_06Aug2020) (added 06/08/2020)

Publication list

Publication citations

Additional files

Editorial Notes

07/08/2020: The main contact was changed in the plain English summary. 06/08/2020: The following changes were made to the trial record: 1. The target number of participants was changed from "Participants = approx. 4350 total (4000 india, 200 Colombia, 150 Malaysia)" to "Participants = approx. 4242 total (3945 india, 208 Colombia, 89 Malaysia)". 2. A public contact was removed. 3. The trial participating centres Laboratorios Servier de Colombia SAS and Servier Malaysia SDN. BHD. were added. 4. The basic results of this trial have been uploaded as an additional file. 13/12/2017: Dr Harpreet Lhoste ( has been removed as a study contact. Nathalie Barbet ( and Romualda Villatte ( have been added. Ethics approval information has been updated. The overall trial end date has been updated from 31/12/2016 to 30/06/2018. 19/09/2016: Internal review.