Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With VerapamilSR/ Trandolapril Fixed Combination (Tarka®) in Patients With Essential Hypertension in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 3,828
- 试验地点
- 134
- 主要终点
- Compliance With Tarka Treatment, All Participants and by Gender.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Compliance With Tarka Treatment, All Participants and by Gender.
时间窗: Month 6 Visit
Participants were asked how many doses of Tarka they had missed since their previous visit.
次要结局
- Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(Baseline to Month 6 Visit)
- Percentage of Patients Achieving Blood Pressure < 140/90 mmHg(Month 6 Visit)
- Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal(Month 6 Visit)
- Adverse Events Leading to Study Discontinuation(Baseline to Month 6 Visit)