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
Abstract at ESH congress 2019
Planning publication in an 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
2018 results in https://doi.org/10.15829/1560-4071-2018-12-64-74 (added 12/11/2020)