A fixed combination of amlodipine and indapamide retard in the treatment of uncontrolled arterial hypertension in people over 55
| ISRCTN | ISRCTN40812831 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40812831 |
| Secondary identifying numbers | IC4-05520-047-RUS |
- Submission date
- 26/09/2019
- Registration date
- 14/10/2019
- Last edited
- 07/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Peoples' Friendship University of Russia
Mikuho-Mallaya, 6
Moscow
117198
Russian Federation
 ORCID ID |
0000-0002-5873-1768 |
|---|---|
| Phone | +7 (499) 134-65-91 |
| tolkachevav@mail.ru |
Study information
| Study design | Multicenter observational open-label uncontrolled program |
|---|---|
| Primary study design | Observational |
| Secondary study design | RWE |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of the efficacy and tolerability of a fixed-dose combination of amlodipine and indapamide in patients older than 55 years |
| Study acronym | ARBALET |
| Study objectives | 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(s) | Ethics approval was not required (under Russian law) for this observational study |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/05/2017 |
| Completion date | 22/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 2217 |
| Total final enrolment | 2217 |
| Key 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. |
| Key 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) |
| Date of first enrolment | 26/08/2017 |
| Date of final enrolment | 22/08/2018 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Moscow
117198
Russian Federation
Sponsor information
Other
Lesnaya st., 7
Moscow
125196
Russian Federation
| Phone | +7(495)9370700 |
|---|---|
| Yuriy.Burtsev.part@servier.com | |
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Abstract at ESH congress 2019 Planning publication in an international journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/12/2018 | 12/11/2020 | Yes | No |
| Results article | 04/03/2022 | 07/03/2022 | Yes | No |
Editorial Notes
07/03/2022: Publication reference added.
12/11/2020: Publication reference added.
07/10/2019: Trial’s existence confirmed by Servier
