Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With Tarka® Fixed Combination in Patients With Essential Hypertension

Abbott

Status: Completed

Conditions: Essential Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT01127139

P12-161

Details and patient eligibility

About

The fixed combination of verapamil SR/trandolapril (Tarka®) is an effective, well-tolerated therapy for the treatment of essential hypertension in those who require more than one agent to achieve optimal blood pressure (BP) control. The endpoint is compliance with Tarka® treatment by number/percentage of patients continued on fixed combination Tarka therapy after six months. This Post Marketing Observational Study will be conducted in a prospective, single-arm, single-country, multicenter format. The investigational sites will be the cardiologists, the doctors of internal medicine and general practicians. Since this will be a Post Marketing Observational Study, Tarka® will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as the local guidelines.

Full description

Follow-up of patients enables 4 patient visits during this period. For these reasons, the most likely visits are defined as "Inclusion visit" at which treatment with Tarka® is to be initiated, and then "Follow-up visit Week 4-6", "Follow-up visit Month 3 " and "Follow-up visit Month 6", although dates will depend only on the decision of the physician. For these reasons, the most likely visits are defined as "S/V" (Screening Visit), "F1" (Follow-up 1), "F2" (Follow-up 2), "F3" (Follow-up 3). The end point is compliance with Tarka® treatment by number/percentage of patients continued on fixed combination Tarka therapy after six months.

Enrollment: 3,828 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men, women more than 18 years
• Patients with uncontrolled essential hypertension eligible to Tarka treatment according to local label (BP ≥ 140/90 mmHg)
• Patients providing oral informed consent (including consent of their medical data to be used for a Post Marketing Observational Study) and cooperating with physician
• Patients who never received Tarka® in the past
• Patients whom Tarka® will be prescribed according to the labelled indication and dose

Exclusion criteria

• Patients contraindicated for treatment of Tarka® according to the local Summary of Product Characteristics (SmPC):
• Hypersensitive to the active substances or to any of the inactive ingredients
• With cardiogenic shock
• With second and third degree atrioventricular block - except in patients with a functioning artificial pacemaker
• With sick sinus syndrome - except in patients with a functioning artificial pacemaker
• With atrial fibrillation/flutter and concomitant Wolff-Parkinson-White syndrome
• With existing history of angioedema associated with administration of an ACE inhibitor
• With severe renal (creatinine clearance < 10 ml/min) or severe liver impairment (cirrhosis with ascites)
• Pregnant women, women of childbearing potential who are unwilling to use contraception
• Lactating women
• Patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies
• Patients currently treated with other fixed antihypertensive combination

Trial design

3,828 participants in 1 patient group

Czech patients with essential hypertension

Description:

Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.