NCT07847970Active, not recruiting
VITAL: Real-World Evaluation of Amlodipine/Valsartan.
Evaluation of Clinical Effectiveness in Real-World Clinical Practice, as Well as the Safety and Adherence to Therapy With a Fixed-Dose Combination of Amlodipine and Valsartan
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
The goal of this observational study is to evaluate the effectiveness, safety, and treatment adherence of a fixed-dose combination of amlodipine and valsartan in adults with grade 2-3 hypertension in real-world clinical practice in Kazakhstan. The study will include patients who have already been prescribed the fixed-dose combination of amlodipine and valsartan (Agvistat®) by their treating physician as part of routine medical care, independently of their participation in the study. The main questions it aims to answer are: What proportion of participants achieve the target blood pressure after 12 weeks of treatment with the fixed-dose combination of amlodipine and valsartan? How well do participants adhere to treatment, and what patient characteristics are associated with treatment adherence? What changes occur in blood pressure, heart rate, quality of life, and selected laboratory measures during the 12-week observation period? What adverse events occur during treatment? Participants will: Have their clinical and demographic information and data from routine medical care recorded during the study. Have blood pressure, heart rate, and other relevant clinical data assessed during the 12-week observation period. Complete questionnaires assessing treatment adherence and quality of life. Participate in follow-up visits at 4, 8, and 12 weeks; the 4- and 8-week visits will be conducted remotely, while the enrollment and 12-week visits will be conducted at the study site.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 216 (actual)
- First submitted
- 14 Sept 2026
- Start date
- 20 Nov 2025
- Primary completion date
- 20 Sept 2026
- Lead sponsor
- VIVA PHARM LLP
- Diseases
- High blood pressure
- NCT number
- NCT07847970
What you commit to
- Study type: Observational
- Participants enrolled: 216
- From 20 Nov 2025 to the primary completion date, 20 Sept 2026
- 18 sites 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
- Participation in any randomized controlled trial within 3 months before enrollment in this study or during participation in this study.
Other illness
- Secondary hypertension.
Lab values
- Atrial fibrillation; severe chronic heart failure (NYHA functional class III-IV or left ventricular ejection fraction ≤40% by echocardiography); or acute coronary syndrome or acute cerebrovascular event within the previous year.
- Contraindications or conditions requiring caution listed in the prescribing information for the fixed-dose combination of amlodipine and valsartan, including: hypersensitivity to the active substances, other dihydropyridine derivatives, or any excipients; severe hepatic impairment, biliary cirrhosis, or cholestasis; concomitant use of aliskiren-containing medicinal products in patients with diabetes mellitus or renal impairment (eGFR \<60 mL/min/1.73 m²); second or third trimester of pregnancy; severe hypotension; shock, including cardiogenic shock; left ventricular outflow tract obstruction, including hypertrophic obstructive cardiomyopathy or severe aortic stenosis; and hemodynamically unstable heart failure following acute myocardial infarction.
Who the study is looking for
- Male or female participants aged ≥18 years at the time of enrollment.
- Signed and dated written informed consent in accordance with ICH GCP and applicable local legislation before enrollment in the study.
- Women of childbearing potential must use an adequate method of contraception throughout the study.
- Documented diagnosis of grade 2-3 hypertension according to current clinical guidelines for hypertension, defined as systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg measured at two different visits.
- Treatment with a fixed-dose combination of amlodipine and valsartan (Agvistat®) prescribed by the treating physician as part of standard clinical practice before enrollment, independently of participation in this study.
- Medical history indicating failure to achieve target blood pressure while receiving a free combination of antihypertensive drugs.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sara Clinic Medical Centre LLP Coordinator of this site? Confirm its status | Aktobe | Kazakhstan | Unknown status |
| 'Kuanysh' LLP Health Centre Coordinator of this site? Confirm its status | Aktobe | Kazakhstan | Unknown status |
| 'Phoenix Hospital' LLP Coordinator of this site? Confirm its status | Aktobe | Kazakhstan | Unknown status |
| 'Vector Vita' Medical Centre LLP Coordinator of this site? Confirm its status | Almaty | Kazakhstan | Unknown status |
| State-owned Enterprise for Public Health 'National Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan' Coordinator of this site? Confirm its status | Almaty | Kazakhstan | Unknown status |
| "Medical Assistance Group" LLP Coordinator of this site? Confirm its status | Almaty | Kazakhstan | Unknown status |
| "Kazakhstan Social and Medical Company 'ZHANYA' LLP" Coordinator of this site? Confirm its status | Astana | Kazakhstan | Unknown status |
| "Green Clinic" LLP Coordinator of this site? Confirm its status | Astana | Kazakhstan | Unknown status |
| State-owned Enterprise 'Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan' Coordinator of this site? Confirm its status | Astana | Kazakhstan | Unknown status |
| "Esculap-Vita" LLP Coordinator of this site? Confirm its status | Shymkent | Kazakhstan | Unknown status |
| "Medical Center Shubarsu" LLP Coordinator of this site? Confirm its status | Shymkent | Kazakhstan | Unknown status |
| "OrkenMed" LLP Coordinator of this site? Confirm its status | Shymkent | Kazakhstan | Unknown status |
| "Clinic DL-ECO" LLP Coordinator of this site? Confirm its status | Shymkent | Kazakhstan | Unknown status |
| 'Ai-Nury' Medical Centre LLP Coordinator of this site? Confirm its status | Shymkent | Kazakhstan | Unknown status |
| "Clinic of Doctor Irsaliev N.R." LLP Coordinator of this site? Confirm its status | Turkestan | Kazakhstan | Unknown status |
| 'GaMMA' Clinical and Diagnostic Centre LLP Coordinator of this site? Confirm its status | Ust-Kamenogorsk | Kazakhstan | Unknown status |
| The 'Outpatient Centre' organisation Coordinator of this site? Confirm its status | Ust-Kamenogorsk | Kazakhstan | Unknown status |
| State Communal Enterprise on the Right of Economic Management "East Kazakhstan Regional Hospital Coordinator of this site? Confirm its status | Ust-Kamenogorsk | Kazakhstan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.