NCT06259175Completed
Evaluation of the Antihypertensive effectIveness, Tolerability, and Adherence With Amlodipine/ Indapamide/ Perindopril Triple Single-pill Combination in Hypertensive Patients Without Concomitant Antihypertensive Therapy (TRIPTYCH)
Source: ClinicalTrials.gov · Last updated 11 Jun 2025
Brief summary (registry, in English)
This is a multi-centre, observational, ambispective study, which will retrospectively and prospectively collect clinical and socio-demographic data from medical records of outpatients with arterial hypertension (HTN) initiated with the amlodipine/indapamide/perindopril SPC in real clinical settings. 375 patients to be included in the study in order for at least 300 patients to complete the study and provide an estimated 90% power of the study. 75 outpatient general practitioners and cardiologists will participate in this study.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 396 (actual)
- First submitted
- 6 Feb 2024
- Start date
- 1 May 2024
- Primary completion date
- 21 Apr 2025
- Lead sponsor
- Servier Russia
- Diseases
- High blood pressure
- NCT number
- NCT06259175
What you commit to
- Study type: Observational
- Participants enrolled: 396
- From 1 May 2024 to the primary completion date, 21 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any contraindication to the treatment with the amlodipine/indapamide/perindopril SPC according to its' approved SmPC for medical use in RF.
- Any severe, decompensated or unstable somatic diseases or conditions that according to investigator discretion are life-threatening or worsen the prognosis for the patient: stroke/TIA, myocardial infarction or unstable angina occurred within 3 months before the inclusion date, angina pectoris IV functional class, chronic heart failure IV functional class by NYHA, current decompensation of diabetes mellitus, autoimmune or oncological diseases, severe or chronic poorly controlled cardiac arrhythmias, gastrointestinal disorders affecting absorption, severe hepatic diseases, pancreatic diseases, severe allergic reactions, connective tissue diseases etc.
- Alcohol or any drug abuse.
- Any contraindication to the treatment with the amlodipine/indapamide/perindopril SPC according to its' approved SmPC for medical use in RF occurred during the follow-up period.
Other illness
- Secondary arterial hypertension.
- Surgical interventions on heart or coronary vessels (i.e., heart valve replacement, stent implantation or CABG), or any non-cardiological serious surgical intervention that are planned within next 3 months and may require withdrawal or changes in current therapy.
Lab values
- Presence of indications for concomitant therapy with β-blockers, α-blockers, I1-imidazoline receptor agonists, loop and potassium-sparing diuretics.
- Clinical situation(s) requiring adding to the SPC other CV medicines such as β-blockers, α-blockers, I1-imidazoline receptor agonists, diuretics, calcium antagonists and/or ACE inhibitors.
Other
- Subjects who are unwilling or unable to provide a signed Informed Consent Form.
- Expected poor adherence to the administration of the prescribed SPC due to patient's lack of co-operation that according to the physician's opinion, is likely to jeopardize the interaction between the patient and the investigator during the study.
- Participating in any other clinical trial currently or for 30 days period before informed consent was signed.
- Patient's decision to withdraw from the study due to any reasons.
- Clinical situation(s) requiring withdrawing the SPC from the treatment scheme of a patient.
- Uncooperative patient's behavior resulting, upon investigating physician's opinion, in resolute unwillingness of the patient to collaborate with the physician therefore jeopardizing effectiveness of the entire treatment.
Who the study is looking for
- Obtained signed informed consent from the patient.
- Patients of 18 years and older.
- Treatment with the amlodipine/indapamide/perindopril SPC in accordance with the Summary of Product Characteristics (SmPC) approved for medical use in the Russian Federation (RF) (Arterial hypertension - SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg), for a period of 2 to 4 weeks at the time of inclusion in the study.
- Absence of any other additional antihypertensive medical treatment with β-blockers, α-blockers, I1-imidazoline receptor agonists, loop and potassium-sparing diuretics from the initiation of the SPC to the inclusion visit (V1).
- Clinical parameters of the primary interest (resting SBP and DBP) are available in medical records for the nearest date before the initiation of the amlodipine/indapamide/perindopril SPC.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Servier Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.