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

Abbott3,828 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

3,828

Conditions

Essential Hypertension

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (134)

Site Reference ID/Investigator# 44896

Babice, Czechia

Site Reference ID/Investigator# 40910

Beroun, Czechia

Site Reference ID/Investigator# 40908

Bílovec, Czechia

Site Reference ID/Investigator# 38816

Blansko, Czechia

Site Reference ID/Investigator# 41189

Brandýs nad Labem, Czechia

Site Ref # / Investigator 40958

Outcomes

Primary Outcomes

Compliance With Tarka Treatment, All Participants and by Gender.

Participants were asked how many doses of Tarka they had missed after three months of treatment.

Time frame: Month 3 Visit

Compliance With Tarka Treatment, All Participants and by Gender.

Participants were asked how many doses of Tarka they had missed since their previous visit.

Time frame: Month 6 Visit

Secondary Outcomes

Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

The mean (average) change in participants' systolic blood pressure and diastolic blood pressure from the baseline visit to the Month 6 visit.

Time frame: Baseline to Month 6 Visit

Percentage of Patients Achieving Blood Pressure < 140/90 mmHg

The percentage of patients who had achieved blood pressure less than 140/90 mmHg after three months of treatment.

Time frame: Month 3 Visit

Percentage of Patients Achieving Blood Pressure < 140/90 mmHg

The percentage of patients who had achieved blood pressure less than 140/90 mmHg after six months of treatment.

Time frame: Month 6 Visit

Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal

The number of participants at the Month 3 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach blood a pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.

Time frame: Month 3 Visit

Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal

The number of participants at the Month 6 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach a blood pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized.

Time frame: Month 6 Visit

Adverse Events Leading to Study Discontinuation

The number of participants who discontinued from the study due to an adverse event and reported event descriptions are summarized.

Time frame: Baseline to Month 6 Visit