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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01127139
First received: May 19, 2010
Last updated: March 30, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
Essential Hypertension

Study Type: Observational
Study Design: Time Perspective: Prospective
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Compliance With Tarka Treatment, All Participants and by Gender. [ Time Frame: Month 3 Visit ] [ Designated as safety issue: No ]
    Participants were asked how many doses of Tarka they had missed after three months of treatment.

  • Compliance With Tarka Treatment, All Participants and by Gender. [ Time Frame: Month 6 Visit ] [ Designated as safety issue: No ]
    Participants were asked how many doses of Tarka they had missed since their previous visit.


Secondary Outcome Measures:
  • Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [ Time Frame: Baseline to Month 6 Visit ] [ Designated as safety issue: No ]
    The mean (average) change in participants' systolic blood pressure and diastolic blood pressure from the baseline visit to the Month 6 visit.

  • Percentage of Patients Achieving Blood Pressure < 140/90 mmHg [ Time Frame: Month 3 Visit ] [ Designated as safety issue: No ]
    The percentage of patients who had achieved blood pressure less than 140/90 mmHg after three months of treatment.

  • Percentage of Patients Achieving Blood Pressure < 140/90 mmHg [ Time Frame: Month 6 Visit ] [ Designated as safety issue: No ]
    The percentage of patients who had achieved blood pressure less than 140/90 mmHg after six months of treatment.

  • Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal [ Time Frame: Month 3 Visit ] [ Designated as safety issue: No ]
    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.

  • Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal [ Time Frame: Month 6 Visit ] [ Designated as safety issue: No ]
    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.

  • Adverse Events Leading to Study Discontinuation [ Time Frame: Baseline to Month 6 Visit ] [ Designated as safety issue: No ]
    The number of participants who discontinued from the study due to an adverse event and reported event descriptions are summarized.


Enrollment: 3828
Study Start Date: April 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Czech patients with essential hypertension
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®.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127139

  Show 134 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Adam Hloska, M.D. Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01127139     History of Changes
Other Study ID Numbers: P12-161
Study First Received: May 19, 2010
Results First Received: March 30, 2012
Last Updated: March 30, 2012
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Abbott:
Essential hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013