Condition category
Circulatory System
Date applied
25/09/2019
Date assigned
18/11/2019
Last edited
18/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
In clinical practice, doctors may struggle to get their patients’ blood pressure controlled, and patients might not follow their recommended treatment.
The aim of this study is to assess if training of the physicians and patients with essential hypertension and use of the single-pill combination of the blood pressure controlling drugs perindopril/indapamide may improve hypertensive efficacy of treatment and treatment compliance.


Who can participate?
Patients with essential hypertension

What does the study involve?
This study collects data from patients treated with the drug perindopril arginine 10 mg/indapamide 2.5 mg (alone or in addition to other antihypertensive drugs), according to their doctor’s decision. Patients are assigned into one of the three groups. In group 1, patients are followed-up by the physician according to routine clinical practice; in group 2, physicians receive training; in group 3, physicians receive training and patients are trained in self-monitoring of BP. All patients received the treatment with single pill combination perindopril/indapamide.

What are the possible benefits and risks of participating?
In this study the decision about an administration of single pill combination perindopril/indapamide was made by the physician in accordance with clinical practice. Therefore, any potential drug-related benefit or risk is linked to label for this drug.

Where is the study run from?
Department of Preventive and Emergency Cardiology, Sechenov First Moscow State Medical University

When is the study starting and how long is it expected to run for?
November 2014 to April 2016

Who is funding the study?
Servier Pharmaceuticals

Who is the main contact?
Prof. Maria Glezer
287ast@mail.ru

Trial website

Contact information

Type

Scientific

Primary contact

Prof Maria Glezer

ORCID ID

http://orcid.org/0000-0002-0995-1924

Contact details

Department of Preventive and Emergency Cardiology
Sechenov First Moscow State Medical University. 2-4 Bolshaya Pirogovskaya st.
Moscow
119991
Russian Federation
+7(985)7630420
rektorat@sechenov.ru

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IC4-06597-011-RUS

Study information

Scientific title

Non-interventional educational multicenter open-label study to assess efficacy of training of the physicians and patients with essential hypertension receiving Perindopril/Indapamide single-pill combination to achieve the target levels of blood pressure and to increase the treatment compliance

Acronym

FORSAGE

Study hypothesis

Physician and patient training and use of single-pill combination of perindopril/indapamide may improve antihypertensive efficacy and treatment compliance

Ethics approval

Approved 20/06/2014, Interuniversity Ethical Committee (119002, 37, bld. 2, Gagarinsky Lane, Moscow, tel. +7 (916) 2607664), ref: 06-14

Study design

Non-interventional educational multicenter open-label study

Primary study design

Observational

Secondary study design

Cohort 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

Arterial hypertension

Intervention

This study collects data from patients treated with the drug perindopril arginine 10 mg/indapamide 2.5 mg (alone or in addition to other antihypertensive drugs), according to their doctor’s decision.

Patients are assigned into one of the three groups. In group 1, patients are followed-up by the physician according to routine clinical practice; in group 2, physicians receive training; in group 3, physicians receive training and patients are trained in self-monitoring of blood pressure.
Patient blood pressure, as well as safety, is evaluated at baseline, then 2 weeks, 1 and 3 months after starting treatment with perindopril/indapamide single pill combination. Questionnaires are administered at baseline and end of the study.

The physician training includes the detailed consulting of the patient in problems of arterial hypertension (AH), providing of printed matter regarding the problem of AH, blood pressure (BP) control, diet in patients with AH, physical load, quitting smoking.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Blood pressure (mmHg) at baseline and 3-months

Secondary outcome measures

1. Achievement of target levels of BP
2. Treatment compliance
3. Adverse Event/Adverse Reaction

Overall trial start date

12/04/2014

Overall trial end date

18/04/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult patients (≥18 years)
2. Essential hypertension
3. BP > 150 /90 mmHg at the background of the current therapy
4. Physician’s decision to administer Perindopril/Indapamide Single-Pill Combination due to inefficacy of the previous monotherapy or combination therapy and according to the indications
5. Patient’s consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Total final enrolment

1969

Participant exclusion criteria

1. Secondary hypertension
2. Pregnancy, breast-feeding
3. Severe cardiovascular disease (acute myocardial infarction or acute cerebrovascular accident within the last 6 months)
4. Diabetes mellitus in the stage of decompensation
5. Severe hepatic impairment
6. Renal transplantation
7. Nephrectomy or the presence of a single kidney
8. Hypokalemia or hyperkalemia
9. Chronic alcoholism, abuse of drugs
10. Contraindications for taking indapamide/perindopril arginine 2.5 mg/10mg or individual components
11. History of ACEi/indapamide/sulfonamide intolerance
12. Systemic connective tissue diseases
13. Aortic stenosis
14. Malignant neoplasm
15. Hypersensitivity reactions of any etiology
16. Presence of indapamide 1.25 mg/perindopril 5 mg or indapamide 2.5 mg/ perindopril 10 mg or free combination of its compounds (perindopril/indapamide) in a current therapy

Recruitment start date

01/11/2014

Recruitment end date

28/02/2015

Locations

Countries of recruitment

Russian Federation

Trial participating centre

Department of Preventive and Emergency Cardiology, Sechenov First Moscow State Medical University
2-4 Bolshaya Pirogovskaya str.
Moscow
119991
Russian Federation

Sponsor information

Organisation

JBC ‘Servier’

Sponsor details

bld.7
Lesnaja str.
Moscow
125196
Russian Federation
+7(495) 937-0700
natalya.logunova@servier.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Servier

Alternative name(s)

Servier Laboratories, Laboratoires Servier

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

France

Results and Publications

Publication and dissemination plan

We are planning the publication in the journal Cardiology and Therapy.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository

Intention to publish date

31/03/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/28294726 (added 26/09/2019)

Publication citations

Additional files

Editorial Notes

NHW 02/10/2019: Trial’s existence confirmed by Interuniversity Ethical Committee