Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
VIVA PHARM LLP
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
