NCT07847970Fut, nem toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 29.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 216 (tényleges)
- Első benyújtás
- 2026. szept. 14.
- Kezdés
- 2025. nov. 20.
- Elsődleges befejezés
- 2026. szept. 20.
- Fő szponzor
- VIVA PHARM LLP
- Betegségek
- Magas vérnyomás
- NCT-szám
- NCT07847970
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 216
- 2025. nov. 20. és az elsődleges befejezés (2026. szept. 20.) között
- 18 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Participation in any randomized controlled trial within 3 months before enrollment in this study or during participation in this study.
Más betegség
- Secondary hypertension.
Laborértékek
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (18)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Sara Clinic Medical Centre LLP | Aktobe | Kazahsztán | Ismeretlen állapot |
| 'Kuanysh' LLP Health Centre | Aktobe | Kazahsztán | Ismeretlen állapot |
| 'Phoenix Hospital' LLP | Aktobe | Kazahsztán | Ismeretlen állapot |
| 'Vector Vita' Medical Centre LLP | Almaty | Kazahsztán | Ismeretlen állapot |
| State-owned Enterprise for Public Health 'National Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan' | Almaty | Kazahsztán | Ismeretlen állapot |
| "Medical Assistance Group" LLP | Almaty | Kazahsztán | Ismeretlen állapot |
| "Kazakhstan Social and Medical Company 'ZHANYA' LLP" | Astana | Kazahsztán | Ismeretlen állapot |
| "Green Clinic" LLP | Astana | Kazahsztán | Ismeretlen állapot |
| State-owned Enterprise 'Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan' | Astana | Kazahsztán | Ismeretlen állapot |
| "Esculap-Vita" LLP | Shymkent | Kazahsztán | Ismeretlen állapot |
| "Medical Center Shubarsu" LLP | Shymkent | Kazahsztán | Ismeretlen állapot |
| "OrkenMed" LLP | Shymkent | Kazahsztán | Ismeretlen állapot |
| "Clinic DL-ECO" LLP | Shymkent | Kazahsztán | Ismeretlen állapot |
| 'Ai-Nury' Medical Centre LLP | Shymkent | Kazahsztán | Ismeretlen állapot |
| "Clinic of Doctor Irsaliev N.R." LLP | Turkestan | Kazahsztán | Ismeretlen állapot |
| 'GaMMA' Clinical and Diagnostic Centre LLP | Ust-Kamenogorsk | Kazahsztán | Ismeretlen állapot |
| The 'Outpatient Centre' organisation | Ust-Kamenogorsk | Kazahsztán | Ismeretlen állapot |
| State Communal Enterprise on the Right of Economic Management "East Kazakhstan Regional Hospital | Ust-Kamenogorsk | Kazahsztán | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.