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

2026년 9월 24일 업데이트: 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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

관찰

등록 (실제)

216

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
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.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of participants achieving target blood pressure at 12 weeks
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Association between treatment adherence and clinical and demographic characteristics
기간: 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
기간: 12 weeks

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

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

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

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

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

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

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

VIVA PHARM LLP

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 11월 20일

기본 완료 (추정된)

2026년 9월 20일

연구 완료 (추정된)

2026년 11월 20일

연구 등록 날짜

최초 제출

2026년 9월 14일

QC 기준을 충족하는 최초 제출

2026년 9월 24일

처음 게시됨 (실제)

2026년 9월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 24일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • VP-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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