HypertensionVITALNCT07847970
VITAL: Real-World Evaluation of Amlodipine/Valsartan.
An observational study of Hypertension and Cardiovascular Diseases (CVD), run by VIVA PHARM LLP at 18 sites in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Diseases (CVD)
- What is being tested?
- Amlodipine / Valsartan
- How many people
- 216 participants
- Where
- 18 sitesKazakhstan
- Study dates
- 20 Nov 2025to 20 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Kazakhstan18 sites
'Kuanysh' LLP Health Centre
Aktobe
'Phoenix Hospital' LLP
Aktobe
Sara Clinic Medical Centre LLP
Aktobe
"Medical Assistance Group" LLP
Almaty
'Vector Vita' Medical Centre LLP
Almaty
State-owned Enterprise for Public Health 'National Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan'
Almaty
"Green Clinic" LLP
Astana
"Kazakhstan Social and Medical Company 'ZHANYA' LLP"
Astana
State-owned Enterprise 'Hospital of the Medical Centre of the Presidential Administration of the Republic of Kazakhstan'
Astana
"Medical Center Shubarsu" LLP
Shymkent, Turkistan Oblast
"Clinic DL-ECO" LLP
Shymkent
"Esculap-Vita" LLP
Shymkent
"OrkenMed" LLP
Shymkent
'Ai-Nury' Medical Centre LLP
Shymkent
"Clinic of Doctor Irsaliev N.R." LLP
Turkestan, Turkistan Oblast
'GaMMA' Clinical and Diagnostic Centre LLP
Ust-Kamenogorsk
State Communal Enterprise on the Right of Economic Management "East Kazakhstan Regional Hospital
Ust-Kamenogorsk
The 'Outpatient Centre' organisation
Ust-Kamenogorsk
About this study
Official title: 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:
Read more
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)
- Being tested
- Amlodipine / Valsartan
- Keywords
- hypertension, amlodipine, valsartan
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine / ValsartanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Amlodipine / Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (12)
Association between treatment adherence and clinical and demographic characteristics
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.
Measured: 12 weeks
Change in heart rate from baseline
Change in heart rate from baseline during the observation period.
Measured: 12 weeks
Change in alanine aminotransferase (ALT) from baseline
Change in alanine aminotransferase (ALT) level from baseline during the observation period.
Measured: 12 weeks
Change in aspartate aminotransferase (AST) from baseline
Change in aspartate aminotransferase (AST) level from baseline during the observation period.
Measured: 12 weeks
Change in serum creatinine from baseline
Change in serum creatinine level from baseline during the observation period.
Measured: 12 weeks
Change in blood glucose from baseline
Change in blood glucose level from baseline during the observation period.
Measured: 12 weeks
Change in low-density lipoprotein cholesterol from baseline
Change in low-density lipoprotein cholesterol (LDL-C) level from baseline during the observation period.
Measured: 12 weeks
Change in body mass index from baseline
Change in body mass index (BMI) from baseline during the observation period.
Measured: 12 weeks
Change in EQ-5D quality of life score
Change in the score of the standardized EQ-5D quality of life questionnaire during the observation period.
Measured: 12 weeks
Association of clinical and demographic factors with achievement of target blood pressure
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.
Measured: 12 weeks
Patient satisfaction with treatment
Assessment of participants' satisfaction with treatment using a 5-point Likert scale.
Measured: 12 week
Frequency and characteristics of adverse drug reactions
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start20 Nov 2025
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVA PHARM LLP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847970
- Sponsor's protocol ID
- VP-01
- Acronym
- VITAL
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07847970
- Acronym / sponsor ID
- VITAL / VP-01
- Conditions
- Hypertension, Cardiovascular Diseases (CVD)
- Keywords
- hypertension, amlodipine, valsartan
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (actual)
- Lead sponsor
- VIVA PHARM LLPIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amlodipine/valsartan-treated cohort | – | Drug: Amlodipine / ValsartanAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amlodipine / ValsartanFixed-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. | Drug | Amlodipine/valsartan-treated cohort |
Primary outcome
Proportion of participants achieving target blood pressure at 12 weeks
Time frame: 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 secondary outcomes
Association between treatment adherence and clinical and demographic characteristics
Time frame: 12 weeks
Change in heart rate from baseline
Time frame: 12 weeks
Change in alanine aminotransferase (ALT) from baseline
Time frame: 12 weeks
Change in aspartate aminotransferase (AST) from baseline
Time frame: 12 weeks
Change in serum creatinine from baseline
Time frame: 12 weeks
Change in blood glucose from baseline
Time frame: 12 weeks
Change in low-density lipoprotein cholesterol from baseline
Time frame: 12 weeks
Change in body mass index from baseline
Time frame: 12 weeks
Change in EQ-5D quality of life score
Time frame: 12 weeks
Association of clinical and demographic factors with achievement of target blood pressure
Time frame: 12 weeks
Patient satisfaction with treatment
Time frame: 12 week
Frequency and characteristics of adverse drug reactions
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Cardiovascular Diseases (CVD), run by VIVA PHARM LLP at 18 sites in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving target blood pressure at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.