VITAL: Real-World Evaluation of Amlodipine/Valsartan.

NCT07847970 | Active Not Recruiting

• 1 other identifier: VP-01
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Hypertension; Cardiovascular Diseases (CVD)

Keywords

hypertension; amlodipine; valsartan

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving target blood pressure at 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

Secondary Outcomes (12)

• Association between treatment adherence and clinical and demographic characteristics

  12 weeks

• Change in heart rate from baseline

  12 weeks

• Change in alanine aminotransferase (ALT) from baseline

  12 weeks

• Change in aspartate aminotransferase (AST) from baseline

  12 weeks

• Change in serum creatinine from baseline

  12 weeks

Study Arms (1)

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.

Drug: Amlodipine / Valsartan

Interventions

Amlodipine / Valsartan DRUG

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.

Amlodipine/valsartan-treated cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• VIVA PHARM LLP: lead

Study Sites (18)

"Medical Center Shubarsu" LLP

Shymkent, Turkistan Oblast, Kazakhstan

Location

"Clinic of Doctor Irsaliev N.R." LLP

Turkestan, Turkistan Oblast, Kazakhstan

Location

'Kuanysh' LLP Health Centre

Aktobe, Kazakhstan

Location

'Phoenix Hospital' LLP

Aktobe, Kazakhstan

Location

Sara Clinic Medical Centre LLP

Aktobe, Kazakhstan

Location

"Medical Assistance Group" LLP

Almaty, Kazakhstan

Location

'Vector Vita' Medical Centre LLP

Almaty, Kazakhstan

Location

State-owned Enterprise for Public Health 'National Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan'

Almaty, Kazakhstan

Location

"Green Clinic" LLP

Astana, Kazakhstan

Location

"Kazakhstan Social and Medical Company 'ZHANYA' LLP"

Astana, Kazakhstan

Location

State-owned Enterprise 'Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan'

Astana, Kazakhstan

Location

"Clinic DL-ECO" LLP

Shymkent, Kazakhstan

Location

"Esculap-Vita" LLP

Shymkent, Kazakhstan

Location

"OrkenMed" LLP

Shymkent, Kazakhstan

Location

'Ai-Nury' Medical Centre LLP

Shymkent, Kazakhstan

Location

'GaMMA' Clinical and Diagnostic Centre LLP

Ust-Kamenogorsk, Kazakhstan

Location

State Communal Enterprise on the Right of Economic Management "East Kazakhstan Regional Hospital

Ust-Kamenogorsk, Kazakhstan

Location

The 'Outpatient Centre' organisation

Ust-Kamenogorsk, Kazakhstan

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

Amlodipine, Valsartan Drug Combination

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Valsartan; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amlodipine; Dihydropyridines; Pyridines; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 29, 2026
• Study Start: November 20, 2025
• Primary Completion: September 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KA (18)