Clinical trial NCT01127139: Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With Tarka® Fixed Combination in Patients With Essential Hypertension
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Hypertension
Keywords: Essential hypertension
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-05-20
Enrollment: 3828
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg

Brief summary: 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.

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 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

Primary outcomes:
measure: Compliance With Tarka Treatment, All Participants and by Gender.
timeFrame: Month 3 Visit
measure: Compliance With Tarka Treatment, All Participants and by Gender.
timeFrame: Month 6 Visit
Secondary outcomes:
measure: Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
timeFrame: Baseline to Month 6 Visit
measure: Percentage of Patients Achieving Blood Pressure < 140/90 mmHg
timeFrame: Month 3 Visit
measure: Percentage of Patients Achieving Blood Pressure < 140/90 mmHg
timeFrame: Month 6 Visit
measure: Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
timeFrame: Month 3 Visit
measure: Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal
timeFrame: Month 6 Visit
measure: Adverse Events Leading to Study Discontinuation
timeFrame: Baseline to Month 6 Visit
Other outcomes:
Locations:
city: Babice
country: Czech Republic
facility: Site Reference ID/Investigator# 44896
city: Beroun
country: Czech Republic
facility: Site Reference ID/Investigator# 40910
city: Bilovec
country: Czech Republic
facility: Site Reference ID/Investigator# 40908
city: Blansko
country: Czech Republic
facility: Site Reference ID/Investigator# 38816
city: Brandys nad Labem
country: Czech Republic
facility: Site Reference ID/Investigator# 41189
city: Breclav
country: Czech Republic
facility: Site Reference ID/Investigator# 40918
city: Brno
country: Czech Republic
facility: Site Ref # / Investigator 40958
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 40821
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 40944
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 41112
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 41187
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 41196
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 44887
city: Brumov
country: Czech Republic
facility: Site Reference ID/Investigator# 42083
city: Bruntal
country: Czech Republic
facility: Site Reference ID/Investigator# 40967
city: Bustehrad
country: Czech Republic
facility: Site Reference ID/Investigator# 41119
city: Bustehrad
country: Czech Republic
facility: Site Reference ID/Investigator# 41195
city: Bystrice nad Pernstejnem
country: Czech Republic
facility: Site Reference ID/Investigator# 38836
city: Bystrice nad Pernstejnem
country: Czech Republic
facility: Site Reference ID/Investigator# 41190
city: C. Trebova
country: Czech Republic
facility: Site Ref # / Investigator 41626
city: Ceske Budejovice
country: Czech Republic
facility: Site Reference ID/Investigator# 41191
city: Ceske Budejovice
country: Czech Republic
facility: Site Ref # / Investigator 38710
city: Ceske Budejovice
country: Czech Republic
facility: Site Reference ID/Investigator# 40948
city: Ceske Budejovice
country: Czech Republic
facility: Site Reference ID/Investigator# 40960
city: Ceske Budejovice
country: Czech Republic
facility: Site Reference ID/Investigator# 40914
city: Ceske Budejovice
country: Czech Republic
facility: Site Reference ID/Investigator# 57305
city: Cheb
country: Czech Republic
facility: Site Reference ID/Investigator# 42082
city: Decin
country: Czech Republic
facility: Site Reference ID/Investigator# 38886
city: Decin
country: Czech Republic
facility: Site Reference ID/Investigator# 41110
city: Decin
country: Czech Republic
facility: Site Reference ID/Investigator# 40818
city: Decin
country: Czech Republic
facility: Site Reference ID/Investigator# 40897
city: Decin
country: Czech Republic
facility: Site Ref # / Investigator 40902
city: Hadacka
country: Czech Republic
facility: Site Reference ID/Investigator# 41117
city: Havirov,Ostrava
country: Czech Republic
facility: Site Reference ID/Investigator# 40808
city: Havirov
country: Czech Republic
facility: Site Reference ID/Investigator# 41103
city: Horni Slavkov
country: Czech Republic
facility: Site Reference ID/Investigator# 40909
city: Hradec Kralove
country: Czech Republic
facility: Site Reference ID/Investigator# 41185
city: Hradec Kralove
country: Czech Republic
facility: Site Reference ID/Investigator# 41188
city: Hranice u Asa
country: Czech Republic
facility: Site Reference ID/Investigator# 40815
city: Hranice
country: Czech Republic
facility: Site Reference ID/Investigator# 41197
city: Hranice
country: Czech Republic
facility: Site Reference ID/Investigator# 40805
city: Jihlava
country: Czech Republic
facility: Site Reference ID/Investigator# 38736
city: Karlovy Vary
country: Czech Republic
facility: Site Reference ID/Investigator# 38844
city: Kdyne
country: Czech Republic
facility: Site Reference ID/Investigator# 41184
city: Kladno
country: Czech Republic
facility: Site Reference ID/Investigator# 41113
city: Kladno
country: Czech Republic
facility: Site Ref # / Investigator 44894
city: Koprivnice
country: Czech Republic
facility: Site Reference ID/Investigator# 40905
city: Krnov
country: Czech Republic
facility: Site Ref # / Investigator 40961
city: Kunovice
country: Czech Republic
facility: Site Reference ID/Investigator# 40901
city: Kutna Hora
country: Czech Republic
facility: Site Reference ID/Investigator# 41192
city: Litomysl
country: Czech Republic
facility: Site Reference ID/Investigator# 40811
city: Litvinov
country: Czech Republic
facility: Site Reference ID/Investigator# 41106
city: Louny
country: Czech Republic
facility: Site Reference ID/Investigator# 40904
city: Lovosice
country: Czech Republic
facility: Site Reference ID/Investigator# 40969
city: Malsice
country: Czech Republic
facility: Site Reference ID/Investigator# 40953
city: Mlada Boleslav
country: Czech Republic
facility: Site Reference ID/Investigator# 41204
city: Mlada Boleslav
country: Czech Republic
facility: Site Ref # / Investigator 44882
city: Mnichovo Hradiste
country: Czech Republic
facility: Site Reference ID/Investigator# 40804
city: Novy Jicin
country: Czech Republic
facility: Site Ref # / Investigator 41118
city: Novy Jicin
country: Czech Republic
facility: Site Reference ID/Investigator# 40954
city: Nymburk
country: Czech Republic
facility: Site Ref # / Investigator 38569
city: Olomouc
country: Czech Republic
facility: Site Reference ID/Investigator# 41114
city: Olomouc
country: Czech Republic
facility: Site Reference ID/Investigator# 40949
city: Olomouc
country: Czech Republic
facility: Site Reference ID/Investigator# 41107
city: Olomouc
country: Czech Republic
facility: Site Ref # / Investigator 40907
city: Orlova
country: Czech Republic
facility: Site Reference ID/Investigator# 41202
city: Ostrava
country: Czech Republic
facility: Site Reference ID/Investigator# 40816
city: Ostrava
country: Czech Republic
facility: Site Reference ID/Investigator# 40951
city: Ostrava
country: Czech Republic
facility: Site Reference ID/Investigator# 40972
city: Ostrava
country: Czech Republic
facility: Site Reference ID/Investigator# 41194
city: Ostrava
country: Czech Republic
facility: Site Reference ID/Investigator# 40968
city: Pardubice
country: Czech Republic
facility: Site Reference ID/Investigator# 40945
city: Pardubice
country: Czech Republic
facility: Site Reference ID/Investigator# 40957
city: Pardubice
country: Czech Republic
facility: Site Reference ID/Investigator# 41201
city: Pardubice
country: Czech Republic
facility: Site Reference ID/Investigator# 41205
city: Pardubice
country: Czech Republic
facility: Site Reference ID/Investigator# 41625
city: Plasy
country: Czech Republic
facility: Site Reference ID/Investigator# 40900
city: Plzen
country: Czech Republic
facility: Site Reference ID/Investigator# 40956
city: Plzen
country: Czech Republic
facility: Site Reference ID/Investigator# 40896
city: Plzen
country: Czech Republic
facility: Site Ref # / Investigator 46282
city: Podebrady
country: Czech Republic
facility: Site Reference ID/Investigator# 41111
city: Prachatice
country: Czech Republic
facility: Site Ref # / Investigator 40911
city: Prague 10
country: Czech Republic
facility: Site Reference ID/Investigator# 41120
city: Prague 2
country: Czech Republic
facility: Site Reference ID/Investigator# 41108
city: Prague 2
country: Czech Republic
facility: Site Reference ID/Investigator# 40822
city: Prague 3
country: Czech Republic
facility: Site Reference ID/Investigator# 44886
city: Prague 4
country: Czech Republic
facility: Site Ref # / Investigator 40819
city: Prague 4
country: Czech Republic
facility: Site Reference ID/Investigator# 40817
city: Prague 4
country: Czech Republic
facility: Site Reference ID/Investigator# 40812
city: Prague 5
country: Czech Republic
facility: Site Reference ID/Investigator# 38628
city: Prague 5
country: Czech Republic
facility: Site Reference ID/Investigator# 44883
city: Prague 6
country: Czech Republic
facility: Site Reference ID/Investigator# 41193
city: Prague 6
country: Czech Republic
facility: Site Reference ID/Investigator# 44884
city: Prague 6
country: Czech Republic
facility: Site Reference ID/Investigator# 40917
city: Prague 8
country: Czech Republic
facility: Site Reference ID/Investigator# 40913
city: Prague 8
country: Czech Republic
facility: Site Reference ID/Investigator# 41123
city: Prague 8
country: Czech Republic
facility: Site Reference ID/Investigator# 41124
city: Prague 8
country: Czech Republic
facility: Site Reference ID/Investigator# 40903
city: Prague 9
country: Czech Republic
facility: Site Reference ID/Investigator# 38630
city: Prague 9
country: Czech Republic
facility: Site Reference ID/Investigator# 40802
city: Prague 9
country: Czech Republic
facility: Site Reference ID/Investigator# 40823
city: Prelouc
country: Czech Republic
facility: Site Reference ID/Investigator# 41126
city: Prelouc
country: Czech Republic
facility: Site Reference ID/Investigator# 41198
city: Pribram
country: Czech Republic
facility: Site Reference ID/Investigator# 40809
city: Rokycany
country: Czech Republic
facility: Site Reference ID/Investigator# 40952
city: Slany
country: Czech Republic
facility: Site Reference ID/Investigator# 44893
city: Slatinany
country: Czech Republic
facility: Site Reference ID/Investigator# 41109
city: Smrzovka
country: Czech Republic
facility: Site Reference ID/Investigator# 40919
city: Stara Paka
country: Czech Republic
facility: Site Ref # / Investigator 40807
city: Stare Mesto
country: Czech Republic
facility: Site Reference ID/Investigator# 40814
city: Stare Mesto
country: Czech Republic
facility: Site Reference ID/Investigator# 42085
city: Sternberk
country: Czech Republic
facility: Site Reference ID/Investigator# 41104
city: Svitavy
country: Czech Republic
facility: Site Reference ID/Investigator# 38746
city: Tabor
country: Czech Republic
facility: Site Reference ID/Investigator# 41121
city: Teplice
country: Czech Republic
facility: Site Ref # / Investigator 40820
city: Tranovice
country: Czech Republic
facility: Site Reference ID/Investigator# 41203
city: Trebic
country: Czech Republic
facility: Site Reference ID/Investigator# 38739
city: Trinec
country: Czech Republic
facility: Site Reference ID/Investigator# 40970
city: Trinec
country: Czech Republic
facility: Site Reference ID/Investigator# 40971
city: Trinec
country: Czech Republic
facility: Site Reference ID/Investigator# 41200
city: Trutnov
country: Czech Republic
facility: Site Reference ID/Investigator# 40895
city: Turnov
country: Czech Republic
facility: Site Ref # / Investigator 40955
city: Uherske Hradiste
country: Czech Republic
facility: Site Reference ID/Investigator# 40959
city: Uherske Hradiste
country: Czech Republic
facility: Site Reference ID/Investigator# 41182
city: Usti nad Labem
country: Czech Republic
facility: Site Reference ID/Investigator# 40906
city: Usti nad Labem
country: Czech Republic
facility: Site Reference ID/Investigator# 41116
city: Valasske Mezirici
country: Czech Republic
facility: Site Reference ID/Investigator# 40950
city: Vyskov
country: Czech Republic
facility: Site Reference ID/Investigator# 40813
city: Vyskov
country: Czech Republic
facility: Site Reference ID/Investigator# 41105
city: Zabreh
country: Czech Republic
facility: Site Ref # / Investigator 41115
city: Zamberk
country: Czech Republic
facility: Site Reference ID/Investigator# 40916
city: Zdar nad Sazavou
country: Czech Republic
facility: Site Reference ID/Investigator# 41186
city: Zdar nad Sazavou
country: Czech Republic
facility: Site Reference ID/Investigator# 42084
city: Zlonice
country: Czech Republic
facility: Site Reference ID/Investigator# 44895
Study officials:
affiliation: Abbott
name: Adam Hloska, M.D.
role: STUDY_DIRECTOR
References: