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

March 30, 2012 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Essential Hypertension

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.

Study Type

Observational

Enrollment (Actual)

3828

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Czech Republic
- - Babice, Czech Republic, 68703
    - Site Reference ID/Investigator# 44896
  - Beroun, Czech Republic, 26601
    - Site Reference ID/Investigator# 40910
  - Bilovec, Czech Republic, 74301
    - Site Reference ID/Investigator# 40908
  - Blansko, Czech Republic, 678 01
    - Site Reference ID/Investigator# 38816
  - Brandys nad Labem, Czech Republic, 25001
    - Site Reference ID/Investigator# 41189
  - Breclav, Czech Republic, 690 02
    - Site Reference ID/Investigator# 40918
  - Brno, Czech Republic, 602 00
    - Site Ref # / Investigator 40958
  - Brno, Czech Republic, 602 00
    - Site Reference ID/Investigator# 40821
  - Brno, Czech Republic, 602 00
    - Site Reference ID/Investigator# 40944
  - Brno, Czech Republic, 602 00
    - Site Reference ID/Investigator# 41112
  - Brno, Czech Republic, 602 00
    - Site Reference ID/Investigator# 41187
  - Brno, Czech Republic, 602 00
    - Site Reference ID/Investigator# 41196
  - Brno, Czech Republic, 60200
    - Site Reference ID/Investigator# 44887
  - Brumov, Czech Republic, 76331
    - Site Reference ID/Investigator# 42083
  - Bruntal, Czech Republic, 564 21
    - Site Reference ID/Investigator# 40967
  - Bustehrad, Czech Republic, 273 43
    - Site Reference ID/Investigator# 41119
  - Bustehrad, Czech Republic, 273 43
    - Site Reference ID/Investigator# 41195
  - Bystrice nad Pernstejnem, Czech Republic, 593 01
    - Site Reference ID/Investigator# 38836
  - Bystrice nad Pernstejnem, Czech Republic, 593 01
    - Site Reference ID/Investigator# 41190
  - C. Trebova, Czech Republic, 779 00
    - Site Ref # / Investigator 41626
  - Ceske Budejovice, Czech Republic, 323 00
    - Site Reference ID/Investigator# 41191
  - Ceske Budejovice, Czech Republic, 370 01
    - Site Ref # / Investigator 38710
  - Ceske Budejovice, Czech Republic, 370 01
    - Site Reference ID/Investigator# 40948
  - Ceske Budejovice, Czech Republic, 370 01
    - Site Reference ID/Investigator# 40960
  - Ceske Budejovice, Czech Republic, 37001
    - Site Reference ID/Investigator# 40914
  - Ceske Budejovice, Czech Republic, 37001
    - Site Reference ID/Investigator# 57305
  - Cheb, Czech Republic, 35002
    - Site Reference ID/Investigator# 42082
  - Decin, Czech Republic, 405 02
    - Site Reference ID/Investigator# 38886
  - Decin, Czech Republic, 405 02
    - Site Reference ID/Investigator# 41110
  - Decin, Czech Republic, 40501
    - Site Reference ID/Investigator# 40818
  - Decin, Czech Republic, 40502
    - Site Reference ID/Investigator# 40897
  - Decin, Czech Republic, 40505
    - Site Ref # / Investigator 40902
  - Hadacka, Czech Republic, 33141
    - Site Reference ID/Investigator# 41117
  - Havirov, Czech Republic, 736 01
    - Site Reference ID/Investigator# 41103
  - Havirov,Ostrava, Czech Republic, 702 00
    - Site Reference ID/Investigator# 40808
  - Horni Slavkov, Czech Republic, 35731
    - Site Reference ID/Investigator# 40909
  - Hradec Kralove, Czech Republic, 500 02
    - Site Reference ID/Investigator# 41185
  - Hradec Kralove, Czech Republic, 500 02
    - Site Reference ID/Investigator# 41188
  - Hranice, Czech Republic, 753 01
    - Site Reference ID/Investigator# 41197
  - Hranice, Czech Republic, 753 22
    - Site Reference ID/Investigator# 40805
  - Hranice u Asa, Czech Republic, 354 15
    - Site Reference ID/Investigator# 40815
  - Jihlava, Czech Republic, 586 01
    - Site Reference ID/Investigator# 38736
  - Karlovy Vary, Czech Republic, 360 01
    - Site Reference ID/Investigator# 38844
  - Kdyne, Czech Republic, 34 506
    - Site Reference ID/Investigator# 41184
  - Kladno, Czech Republic, 272 01
    - Site Reference ID/Investigator# 41113
  - Kladno, Czech Republic, 27280
    - Site Ref # / Investigator 44894
  - Koprivnice, Czech Republic, 74221
    - Site Reference ID/Investigator# 40905
  - Krnov, Czech Republic, 779 00
    - Site Ref # / Investigator 40961
  - Kunovice, Czech Republic, 68604
    - Site Reference ID/Investigator# 40901
  - Kutna Hora, Czech Republic, 284 01
    - Site Reference ID/Investigator# 41192
  - Litomysl, Czech Republic, 570 01
    - Site Reference ID/Investigator# 40811
  - Litvinov, Czech Republic, 43601
    - Site Reference ID/Investigator# 41106
  - Louny, Czech Republic, 44001
    - Site Reference ID/Investigator# 40904
  - Lovosice, Czech Republic, 41002
    - Site Reference ID/Investigator# 40969
  - Malsice, Czech Republic, 370 01
    - Site Reference ID/Investigator# 40953
  - Mlada Boleslav, Czech Republic, 293 60
    - Site Reference ID/Investigator# 41204
  - Mlada Boleslav, Czech Republic, 29301
    - Site Ref # / Investigator 44882
  - Mnichovo Hradiste, Czech Republic, 295 01
    - Site Reference ID/Investigator# 40804
  - Novy Jicin, Czech Republic, 741 01
    - Site Ref # / Investigator 41118
  - Novy Jicin, Czech Republic, 741 01
    - Site Reference ID/Investigator# 40954
  - Nymburk, Czech Republic, 288 02
    - Site Ref # / Investigator 38569
  - Olomouc, Czech Republic, 772 00
    - Site Reference ID/Investigator# 41114
  - Olomouc, Czech Republic, 781 01
    - Site Reference ID/Investigator# 40949
  - Olomouc, Czech Republic, 783 13
    - Site Reference ID/Investigator# 41107
  - Olomouc, Czech Republic, 79401
    - Site Ref # / Investigator 40907
  - Orlova, Czech Republic, 735 14
    - Site Reference ID/Investigator# 41202
  - Ostrava, Czech Republic, 700 30
    - Site Reference ID/Investigator# 40816
  - Ostrava, Czech Republic, 702 00
    - Site Reference ID/Investigator# 40951
  - Ostrava, Czech Republic, 702 00
    - Site Reference ID/Investigator# 40972
  - Ostrava, Czech Republic, 702 00
    - Site Reference ID/Investigator# 41194
  - Ostrava, Czech Republic, 708 52
    - Site Reference ID/Investigator# 40968
  - Pardubice, Czech Republic, 530 02
    - Site Reference ID/Investigator# 40945
  - Pardubice, Czech Republic, 530 03
    - Site Reference ID/Investigator# 40957
  - Pardubice, Czech Republic, 530 03
    - Site Reference ID/Investigator# 41201
  - Pardubice, Czech Republic, 530 03
    - Site Reference ID/Investigator# 41205
  - Pardubice, Czech Republic, 530 03
    - Site Reference ID/Investigator# 41625
  - Plasy, Czech Republic, 33101
    - Site Reference ID/Investigator# 40900
  - Plzen, Czech Republic, 320 00
    - Site Reference ID/Investigator# 40956
  - Plzen, Czech Republic, 320 01
    - Site Reference ID/Investigator# 40896
  - Plzen, Czech Republic, 32000
    - Site Ref # / Investigator 46282
  - Podebrady, Czech Republic, 290 01
    - Site Reference ID/Investigator# 41111
  - Prachatice, Czech Republic, 34142
    - Site Ref # / Investigator 40911
  - Prague 10, Czech Republic, 110 00
    - Site Reference ID/Investigator# 41120
  - Prague 2, Czech Republic, 120 00
    - Site Reference ID/Investigator# 41108
  - Prague 2, Czech Republic, 128 08
    - Site Reference ID/Investigator# 40822
  - Prague 3, Czech Republic, 13000
    - Site Reference ID/Investigator# 44886
  - Prague 4, Czech Republic, 140 00
    - Site Ref # / Investigator 40819
  - Prague 4, Czech Republic, 140 00
    - Site Reference ID/Investigator# 40817
  - Prague 4, Czech Republic, 149 00
    - Site Reference ID/Investigator# 40812
  - Prague 5, Czech Republic, 150 00
    - Site Reference ID/Investigator# 38628
  - Prague 5, Czech Republic, 15000
    - Site Reference ID/Investigator# 44883
  - Prague 6, Czech Republic, 160 00
    - Site Reference ID/Investigator# 41193
  - Prague 6, Czech Republic, 16000
    - Site Reference ID/Investigator# 44884
  - Prague 6, Czech Republic, 169 00
    - Site Reference ID/Investigator# 40917
  - Prague 8, Czech Republic, 180 00
    - Site Reference ID/Investigator# 40913
  - Prague 8, Czech Republic, 180 00
    - Site Reference ID/Investigator# 41123
  - Prague 8, Czech Republic, 180 00
    - Site Reference ID/Investigator# 41124
  - Prague 8, Czech Republic, 18000
    - Site Reference ID/Investigator# 40903
  - Prague 9, Czech Republic, 190 00
    - Site Reference ID/Investigator# 38630
  - Prague 9, Czech Republic, 190 00
    - Site Reference ID/Investigator# 40802
  - Prague 9, Czech Republic
    - Site Reference ID/Investigator# 40823
  - Prelouc, Czech Republic, 535 01
    - Site Reference ID/Investigator# 41126
  - Prelouc, Czech Republic, 535 01
    - Site Reference ID/Investigator# 41198
  - Pribram, Czech Republic, 26101
    - Site Reference ID/Investigator# 40809
  - Rokycany, Czech Republic, 337 22
    - Site Reference ID/Investigator# 40952
  - Slany, Czech Republic, 274 01
    - Site Reference ID/Investigator# 44893
  - Slatinany, Czech Republic, 538 21
    - Site Reference ID/Investigator# 41109
  - Smrzovka, Czech Republic, 468 51
    - Site Reference ID/Investigator# 40919
  - Stara Paka, Czech Republic, 507 91
    - Site Ref # / Investigator 40807
  - Stare Mesto, Czech Republic, 686 03
    - Site Reference ID/Investigator# 40814
  - Stare Mesto, Czech Republic, 68601
    - Site Reference ID/Investigator# 42085
  - Sternberk, Czech Republic, 779 99
    - Site Reference ID/Investigator# 41104
  - Svitavy, Czech Republic, 568 02
    - Site Reference ID/Investigator# 38746
  - Tabor, Czech Republic, 370 01
    - Site Reference ID/Investigator# 41121
  - Teplice, Czech Republic, 41501
    - Site Ref # / Investigator 40820
  - Tranovice, Czech Republic, 739 53
    - Site Reference ID/Investigator# 41203
  - Trebic, Czech Republic, 674 01
    - Site Reference ID/Investigator# 38739
  - Trinec, Czech Republic, 739 61
    - Site Reference ID/Investigator# 40970
  - Trinec, Czech Republic, 739 61
    - Site Reference ID/Investigator# 40971
  - Trinec, Czech Republic, 739 61
    - Site Reference ID/Investigator# 41200
  - Trutnov, Czech Republic, 54121
    - Site Reference ID/Investigator# 40895
  - Turnov, Czech Republic, 511 01
    - Site Ref # / Investigator 40955
  - Uherske Hradiste, Czech Republic, 686 01
    - Site Reference ID/Investigator# 40959
  - Uherske Hradiste, Czech Republic, 686 01
    - Site Reference ID/Investigator# 41182
  - Usti nad Labem, Czech Republic, 40001
    - Site Reference ID/Investigator# 40906
  - Usti nad Labem, Czech Republic, 40007
    - Site Reference ID/Investigator# 41116
  - Valasske Mezirici, Czech Republic, 757 01
    - Site Reference ID/Investigator# 40950
  - Vyskov, Czech Republic, 682 01
    - Site Reference ID/Investigator# 40813
  - Vyskov, Czech Republic, 682 01
    - Site Reference ID/Investigator# 41105
  - Zabreh, Czech Republic, 560 02
    - Site Ref # / Investigator 41115
  - Zamberk, Czech Republic, 789 01
    - Site Reference ID/Investigator# 40916
  - Zdar nad Sazavou, Czech Republic, 591 01
    - Site Reference ID/Investigator# 41186
  - Zdar nad Sazavou, Czech Republic, 591 01
    - Site Reference ID/Investigator# 42084
  - Zlonice, Czech Republic, 27371
    - Site Reference ID/Investigator# 44895

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 3 Visit
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.	Month 6 Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Month 6 Visit
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.	Month 3 Visit
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.	Month 6 Visit
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.	Month 3 Visit
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.	Month 6 Visit
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.	Baseline to Month 6 Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

Study Director: Adam Hloska, M.D., Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 19, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

March 30, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Essential hypertension

Additional Relevant MeSH Terms

Other Study ID Numbers

P12-161

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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

Study Overview

Status

Conditions

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Essential Hypertension

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