Condition category
Circulatory System
Date applied
26/09/2019
Date assigned
14/10/2019
Last edited
07/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
High blood pressure, or hypertension, rarely has noticeable symptoms. But if untreated, it increases the risk of serious problems such as heart attacks and strokes. The aim of this study is to assess the efficacy and tolerability of a fixed-dose combination of amlodipine and indapamide for the treatment of high blood pressure

Who can participate?
Patients with primary hypertension aged 55 years or older

What does the study involve?
Participants will be treated as usual for hypertension. In order to gather detailed information about the effects of the medication, participants will be required to attend three follow-up visits with their doctor over three months, as well as taking measurements of their blood pressure and heart rate twice per day

What are the possible benefits and risks of participating?
Care will be provided as usual and there are no additional benefits or risks to the participants from taking part in the study

Where is the study run from?
Federal State Autonomous Educational Institution of Higher Education Peoples' Friendship University of Russia (RUDN)

When is the study starting and how long is it expected to run for?
August 2017 to August 2018

Who is funding the study?
Servier, Russia

Who is the main contact?
Zhana Kobalava,
tolkachevav@mail.ru

Trial website

Contact information

Type

Scientific

Primary contact

Ms Zhana Kobalava

ORCID ID

http://orcid.org/0000-0002-5873-1768

Contact details

Peoples' Friendship University of Russia
Mikuho-Mallaya
6
Moscow
117198
Russian Federation
+7 (499) 134-65-91
tolkachevav@mail.ru

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IC4-05520-047-RUS

Study information

Scientific title

Evaluation of the efficacy and tolerability of a fixed-dose combination of amlodipine and indapamide in patients older than 55 years

Acronym

ARBALET

Study hypothesis

To evaluate the efficacy and tolerability of a fixed-dose combination of amlodipine and indapamide in patients older than 55 years with grade 1-2 HT, not achieving BP control on the previous therapy or not receiving antihypertensive therapy.

Ethics approval

Ethics approval was not required (under Russian law) for this observational study

Study design

Multicenter observational open-label uncontrolled program

Primary study design

Observational

Secondary study design

RWE

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

Arterial hypertension

Intervention

The aim of the study is to observe the efficacy and safety of treatment with amlodipine/indapamide fixed-dose combination (FDC) ARIFAM in outpatients with hypertension (HT) aged over 55 years.

The ARIFAM dose was chosen by the doctor from two available dosages of amlodipine/indapamide FDC: 5/1.5 mg and 10/1.5 mg. During the 3-month follow-up period starting from the inclusion visit, the patient visited the doctor three times: after 2 weeks, 1 month and 3 months.

At all visits, blood pressure (BP) and heart rate (HR) were measured in the sitting and standing positions, and well being was assessed using a VAS. At the follow-up visits patients were also asked about adverse events. In addition, at each visit, the diary of BP self-monitoring, which the patient had to complete throughout 7 days prior to visiting the doctor, was analyzed.

ARIFAM was prescribed in accordance with the instruction for use of the drug after the patient had signed the informed consent form. The drug could be prescribed not only to patients with a failure of hypertension control on the previous therapy, but also to those in whom the doctor decided to replace the effective free combination of these drugs with a FDC.

Intervention type

Drug

Phase

Not Applicable

Drug names

Amlodipine and indapamide

Primary outcome measure

Blood pressure and heart rate assessed in the seated and standing positions during consultations with the doctor will be measured in addition to self measurements of BP and HR taken twice daily by participants throughout the three months.

Secondary outcome measures

Subjective evaluation of the effectiveness of therapy by the doctor and patient assessed by interview during follow-up visits (after 2 weeks, 1 month and 3 months)

Overall trial start date

01/05/2017

Overall trial end date

22/08/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 55 years or older
2. Diagnosis of essential (primary) hypertension
3. Suboptimal efficacy of the previous antihypertensive therapy, with clinical SBP 140-179 mm Hg, OR untreated grade 1-2 HT with clinical SBP 140-179 mm Hg, in patients requiring therapy with amlodipine and indapamide.
4. Pulse pressure 60 mm Hg or higher
5. Doctor's decision to prescribe ARIFAM in line with indications.
6. Patient’s informed consent to participate in the program
7. Absence of contraindications to the prescription of ARIFAM, stated in the instruction for medical use of the medicinal product.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

2217

Total final enrolment

2217

Participant exclusion criteria

1. Office BP ≥180/110 mm Hg on the top of treatment (at V1 visit) or ≥200/110 mm Hg if untreated
2. Resistant HT (use of at least 3 antihypertensive drug classes, one of which is diuretics, at maximal doses)
3. Known or suspected symptomatic orthostatic hypotension
4. History of myocardial infarction or cerebrovascular accident within the past 6 months
5. Unstable angina within the past 6 months
6. CHF of class III-IV NYHA
7. Type 1 diabetes mellitus or decompensated type 2 diabetes mellitus
8. Any serious decompensated concomitant diseases requiring regular medical therapy
9. Inability to understand the nature of the program and follow the recommendations
10. Contraindications or known intolerance to diuretics or calcium channel blockers (indapamide and amlodipine)
11. Patient who could/would not stop drinking grapefruit juice during the study (interaction with amlodipine)
12. Current participation in another study or within the preceding 30 days (or a longer period in accordance with local regulations)

Recruitment start date

26/08/2017

Recruitment end date

22/08/2018

Locations

Countries of recruitment

Russian Federation

Trial participating centre

Federal State Autonomous Educational Institution of Higher Education Peoples' Friendship University of Russia (RUDN)
Mikuha-Maklaya, 6
Moscow
117198
Russian Federation

Sponsor information

Organisation

Servier

Sponsor details

Lesnaya st.
7
Moscow
125196
Russian Federation
+7(495)9370700
Yuriy.Burtsev.part@servier.com

Sponsor type

Other

Website

Funders

Funder type

Industry

Funder name

Servier Russia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results published at local Russian Journal of Cardiology. 2018;23(12):64–74
Abstract at ESH congress 2019
Planning publication in international journal

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

Publication citations

Additional files

Editorial Notes

07/10/2019: Trial’s existence confirmed by Servier