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VITAL: Real-World Evaluation of Amlodipine/Valsartan. (VITAL)

24 september 2026 bijgewerkt door: VIVA PHARM LLP

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

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Werkelijk)

216

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Kazachstan
      • Aktobe, Kazachstan
        • 'Kuanysh' LLP Health Centre
      • Aktobe, Kazachstan
        • 'Phoenix Hospital' LLP
      • Aktobe, Kazachstan
        • Sara Clinic Medical Centre LLP
      • Almaty, Kazachstan
        • "Medical Assistance Group" LLP
      • Almaty, Kazachstan
        • 'Vector Vita' Medical Centre LLP
      • Almaty, Kazachstan
        • State-owned Enterprise for Public Health 'National Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan'
      • Astana, Kazachstan
        • "Green Clinic" LLP
      • Astana, Kazachstan
        • "Kazakhstan Social and Medical Company 'ZHANYA' LLP"
      • Astana, Kazachstan
        • State-owned Enterprise 'Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan'
      • Shymkent, Kazachstan
        • "Clinic DL-ECO" LLP
      • Shymkent, Kazachstan
        • "Esculap-Vita" LLP
      • Shymkent, Kazachstan
        • "OrkenMed" LLP
      • Shymkent, Kazachstan
        • 'Ai-Nury' Medical Centre LLP
      • Ust-Kamenogorsk, Kazachstan
        • 'GaMMA' Clinical and Diagnostic Centre LLP
      • Ust-Kamenogorsk, Kazachstan
        • State Communal Enterprise on the Right of Economic Management "East Kazakhstan Regional Hospital
      • Ust-Kamenogorsk, Kazachstan
        • The 'Outpatient Centre' organisation
    • Turkistan Oblast
      • Shymkent, Turkistan Oblast, Kazachstan
        • "Medical Center Shubarsu" LLP
      • Turkestan, Turkistan Oblast, Kazachstan
        • "Clinic of Doctor Irsaliev N.R." LLP

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The study population will consist of adult male and female patients aged ≥18 years with a confirmed diagnosis of grade 2-3 hypertension who have been prescribed a fixed-dose combination of amlodipine and valsartan (Agvistat®) by their treating physician as part of standard clinical practice, independently of participation in the study. The study will include patients with a medical history indicating failure to achieve target blood pressure while receiving a free combination of antihypertensive drugs. A total of 216 participants will be enrolled and observed for up to 12 weeks.

Beschrijving

Inclusion Criteria:

  1. Male or female participants aged ≥18 years at the time of enrollment.
  2. Signed and dated written informed consent in accordance with ICH GCP and applicable local legislation before enrollment in the study.
  3. Women of childbearing potential must use an adequate method of contraception throughout the study.
  4. 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.
  5. 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.
  6. Medical history indicating failure to achieve target blood pressure while receiving a free combination of antihypertensive drugs.

Exclusion Criteria:

  1. Participation in any randomized controlled trial within 3 months before enrollment in this study or during participation in this study.
  2. 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.
  3. Secondary hypertension.
  4. 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Amlodipine/valsartan-treated cohort

Adults with grade 2-3 hypertension who have been prescribed a fixed-dose combination of amlodipine and valsartan (Agvistat®) by their treating physician as part of routine clinical practice, independently of participation in the study. Participants are observed for up to 12 weeks to assess treatment effectiveness, adherence, safety, blood pressure control, and quality of life.
Geneesmiddel: Amlodipine / Valsartan

Fixed-dose combination of amlodipine and valsartan administered as part of routine clinical practice. The treatment is prescribed by the treating physician independently of study participation. The study does not assign treatment or provide the study drug. The available doses are amlodipine 5 mg/valsartan 160 mg and amlodipine 10 mg/valsartan 160 mg, administered once daily.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants achieving target blood pressure at 12 weeks
Tijdsspanne: 12 weeks

Proportion of participants who achieve the target blood pressure after 12 weeks of therapy: <140/90 mmHg for the general population or <130/80 mmHg for participants at high cardiovascular risk and participants younger than 60 years.
12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Association between treatment adherence and clinical and demographic characteristics
Tijdsspanne: 12 weeks

Association between treatment adherence, assessed using the Morisky-Green scale, and clinical and demographic characteristics of participants, including age, sex, comorbidities, and duration of hypertension.
12 weeks
Change in heart rate from baseline
Tijdsspanne: 12 weeks

Change in heart rate from baseline during the observation period.
12 weeks
Change in alanine aminotransferase (ALT) from baseline
Tijdsspanne: 12 weeks

Change in alanine aminotransferase (ALT) level from baseline during the observation period.
12 weeks
Change in aspartate aminotransferase (AST) from baseline
Tijdsspanne: 12 weeks

Change in aspartate aminotransferase (AST) level from baseline during the observation period.
12 weeks
Change in serum creatinine from baseline
Tijdsspanne: 12 weeks

Change in serum creatinine level from baseline during the observation period.
12 weeks
Change in blood glucose from baseline
Tijdsspanne: 12 weeks

Change in blood glucose level from baseline during the observation period.
12 weeks
Change in low-density lipoprotein cholesterol from baseline
Tijdsspanne: 12 weeks

Change in low-density lipoprotein cholesterol (LDL-C) level from baseline during the observation period.
12 weeks
Change in body mass index from baseline
Tijdsspanne: 12 weeks

Change in body mass index (BMI) from baseline during the observation period.
12 weeks
Change in EQ-5D quality of life score
Tijdsspanne: 12 weeks

Change in the score of the standardized EQ-5D quality of life questionnaire during the observation period.
12 weeks
Association of clinical and demographic factors with achievement of target blood pressure
Tijdsspanne: 12 weeks

Association of clinical and demographic factors, including diabetes mellitus, obesity, grade of hypertension, chronic heart failure, age, and sex, with achievement of target blood pressure at 12 weeks of therapy.
12 weeks
Patient satisfaction with treatment
Tijdsspanne: 12 week

Assessment of participants' satisfaction with treatment using a 5-point Likert scale.
12 week
Frequency and characteristics of adverse drug reactions
Tijdsspanne: 12 weeks

Frequency and characteristics of adverse drug reactions associated with the use of the fixed-dose combination of amlodipine and valsartan, identified based on the analysis of adverse reaction reports (Yellow Cards).
12 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

VIVA PHARM LLP

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 november 2025

Primaire voltooiing (Geschat)

20 september 2026

Studie voltooiing (Geschat)

20 november 2026

Studieregistratiedata

Eerst ingediend

14 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 september 2026

Eerst geplaatst (Werkelijk)

29 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 september 2026

Laatste update ingediend die voldeed aan QC-criteria

24 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • VP-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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