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NCT Number: NCT01127139

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

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 44896, Babice, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Compliance With Tarka Treatment, All Participants and by Gender.

    Time frame: Month 3 Visit

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

  2. Compliance With Tarka Treatment, All Participants and by Gender.

    Time frame: Month 6 Visit

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

Secondary outcomes

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

    Time frame: Baseline to Month 6 Visit

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

  2. Percentage of Patients Achieving Blood Pressure < 140/90 mmHg

    Time frame: Month 3 Visit

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

  3. Percentage of Patients Achieving Blood Pressure < 140/90 mmHg

    Time frame: Month 6 Visit

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

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

    Time frame: Month 3 Visit

    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.

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

    Time frame: Month 6 Visit

    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.

  6. Adverse Events Leading to Study Discontinuation

    Time frame: Baseline to Month 6 Visit

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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 20, 2010
Registry last updated
May 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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