Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With Tarka® Fixed Combination in Patients With Essential Hypertension
- Conditions
- Essential Hypertension
- Registration Number
- NCT01127139
- Lead Sponsor
- Abbott
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3828
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compliance With Tarka Treatment, All Participants and by Gender. Month 6 Visit Participants were asked how many doses of Tarka they had missed since their previous visit.
- Secondary Outcome Measures
Name Time Method Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) 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.
Percentage of Patients Achieving Blood Pressure < 140/90 mmHg Month 6 Visit 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 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.
Adverse Events Leading to Study Discontinuation 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.
Trial Locations
- Locations (134)
Site Reference ID/Investigator# 40910
🇨🇿Beroun, Czech Republic
Site Reference ID/Investigator# 42083
🇨🇿Brumov, Czech Republic
Site Reference ID/Investigator# 38836
🇨🇿Bystrice nad Pernstejnem, Czech Republic
Site Reference ID/Investigator# 41110
🇨🇿Decin, Czech Republic
Site Reference ID/Investigator# 44896
🇨🇿Babice, Czech Republic
Site Reference ID/Investigator# 40821
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 41196
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 41191
🇨🇿Ceske Budejovice, Czech Republic
Site Reference ID/Investigator# 41197
🇨🇿Hranice, Czech Republic
Site Reference ID/Investigator# 38816
🇨🇿Blansko, Czech Republic
Site Reference ID/Investigator# 40944
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 41119
🇨🇿Bustehrad, Czech Republic
Site Reference ID/Investigator# 38886
🇨🇿Decin, Czech Republic
Site Reference ID/Investigator# 40805
🇨🇿Hranice, Czech Republic
Site Reference ID/Investigator# 41113
🇨🇿Kladno, Czech Republic
Site Ref # / Investigator 40961
🇨🇿Krnov, Czech Republic
Site Reference ID/Investigator# 41192
🇨🇿Kutna Hora, Czech Republic
Site Reference ID/Investigator# 41625
🇨🇿Pardubice, Czech Republic
Site Reference ID/Investigator# 40900
🇨🇿Plasy, Czech Republic
Site Reference ID/Investigator# 40822
🇨🇿Prague 2, Czech Republic
Site Reference ID/Investigator# 41193
🇨🇿Prague 6, Czech Republic
Site Reference ID/Investigator# 44884
🇨🇿Prague 6, Czech Republic
Site Reference ID/Investigator# 40903
🇨🇿Prague 8, Czech Republic
Site Reference ID/Investigator# 40802
🇨🇿Prague 9, Czech Republic
Site Reference ID/Investigator# 40952
🇨🇿Rokycany, Czech Republic
Site Ref # / Investigator 41626
🇨🇿C. Trebova, Czech Republic
Site Reference ID/Investigator# 44887
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 41190
🇨🇿Bystrice nad Pernstejnem, Czech Republic
Site Reference ID/Investigator# 40948
🇨🇿Ceske Budejovice, Czech Republic
Site Reference ID/Investigator# 40960
🇨🇿Ceske Budejovice, Czech Republic
Site Reference ID/Investigator# 42082
🇨🇿Cheb, Czech Republic
Site Reference ID/Investigator# 40818
🇨🇿Decin, Czech Republic
Site Reference ID/Investigator# 40815
🇨🇿Hranice u Asa, Czech Republic
Site Reference ID/Investigator# 38736
🇨🇿Jihlava, Czech Republic
Site Ref # / Investigator 38569
🇨🇿Nymburk, Czech Republic
Site Reference ID/Investigator# 40949
🇨🇿Olomouc, Czech Republic
Site Ref # / Investigator 40907
🇨🇿Olomouc, Czech Republic
Site Reference ID/Investigator# 40957
🇨🇿Pardubice, Czech Republic
Site Reference ID/Investigator# 40896
🇨🇿Plzen, Czech Republic
Site Reference ID/Investigator# 40908
🇨🇿Bilovec, Czech Republic
Site Reference ID/Investigator# 41189
🇨🇿Brandys nad Labem, Czech Republic
Site Reference ID/Investigator# 40918
🇨🇿Breclav, Czech Republic
Site Reference ID/Investigator# 41112
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 41187
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 40967
🇨🇿Bruntal, Czech Republic
Site Reference ID/Investigator# 40914
🇨🇿Ceske Budejovice, Czech Republic
Site Reference ID/Investigator# 57305
🇨🇿Ceske Budejovice, Czech Republic
Site Reference ID/Investigator# 40897
🇨🇿Decin, Czech Republic
Site Reference ID/Investigator# 41185
🇨🇿Hradec Kralove, Czech Republic
Site Ref # / Investigator 44894
🇨🇿Kladno, Czech Republic
Site Reference ID/Investigator# 40901
🇨🇿Kunovice, Czech Republic
Site Ref # / Investigator 44882
🇨🇿Mlada Boleslav, Czech Republic
Site Reference ID/Investigator# 40954
🇨🇿Novy Jicin, Czech Republic
Site Reference ID/Investigator# 41202
🇨🇿Orlova, Czech Republic
Site Reference ID/Investigator# 41194
🇨🇿Ostrava, Czech Republic
Site Reference ID/Investigator# 41201
🇨🇿Pardubice, Czech Republic
Site Reference ID/Investigator# 41205
🇨🇿Pardubice, Czech Republic
Site Reference ID/Investigator# 40956
🇨🇿Plzen, Czech Republic
Site Ref # / Investigator 46282
🇨🇿Plzen, Czech Republic
Site Ref # / Investigator 40819
🇨🇿Prague 4, Czech Republic
Site Reference ID/Investigator# 40817
🇨🇿Prague 4, Czech Republic
Site Reference ID/Investigator# 44883
🇨🇿Prague 5, Czech Republic
Site Ref # / Investigator 40807
🇨🇿Stara Paka, Czech Republic
Site Reference ID/Investigator# 42085
🇨🇿Stare Mesto, Czech Republic
Site Reference ID/Investigator# 41103
🇨🇿Havirov, Czech Republic
Site Reference ID/Investigator# 40909
🇨🇿Horni Slavkov, Czech Republic
Site Reference ID/Investigator# 38844
🇨🇿Karlovy Vary, Czech Republic
Site Reference ID/Investigator# 41184
🇨🇿Kdyne, Czech Republic
Site Reference ID/Investigator# 40905
🇨🇿Koprivnice, Czech Republic
Site Reference ID/Investigator# 41114
🇨🇿Olomouc, Czech Republic
Site Reference ID/Investigator# 41107
🇨🇿Olomouc, Czech Republic
Site Reference ID/Investigator# 40968
🇨🇿Ostrava, Czech Republic
Site Reference ID/Investigator# 40945
🇨🇿Pardubice, Czech Republic
Site Reference ID/Investigator# 40812
🇨🇿Prague 4, Czech Republic
Site Reference ID/Investigator# 41123
🇨🇿Prague 8, Czech Republic
Site Ref # / Investigator 40820
🇨🇿Teplice, Czech Republic
Site Reference ID/Investigator# 38739
🇨🇿Trebic, Czech Republic
Site Reference ID/Investigator# 41200
🇨🇿Trinec, Czech Republic
Site Reference ID/Investigator# 41182
🇨🇿Uherske Hradiste, Czech Republic
Site Reference ID/Investigator# 40969
🇨🇿Lovosice, Czech Republic
Site Reference ID/Investigator# 41204
🇨🇿Mlada Boleslav, Czech Republic
Site Reference ID/Investigator# 40804
🇨🇿Mnichovo Hradiste, Czech Republic
Site Ref # / Investigator 41118
🇨🇿Novy Jicin, Czech Republic
Site Reference ID/Investigator# 38628
🇨🇿Prague 5, Czech Republic
Site Reference ID/Investigator# 40823
🇨🇿Prague 9, Czech Republic
Site Reference ID/Investigator# 41198
🇨🇿Prelouc, Czech Republic
Site Reference ID/Investigator# 40809
🇨🇿Pribram, Czech Republic
Site Reference ID/Investigator# 41109
🇨🇿Slatinany, Czech Republic
Site Reference ID/Investigator# 41111
🇨🇿Podebrady, Czech Republic
Site Reference ID/Investigator# 41120
🇨🇿Prague 10, Czech Republic
Site Reference ID/Investigator# 41108
🇨🇿Prague 2, Czech Republic
Site Reference ID/Investigator# 40917
🇨🇿Prague 6, Czech Republic
Site Reference ID/Investigator# 40913
🇨🇿Prague 8, Czech Republic
Site Reference ID/Investigator# 41124
🇨🇿Prague 8, Czech Republic
Site Reference ID/Investigator# 38630
🇨🇿Prague 9, Czech Republic
Site Reference ID/Investigator# 41126
🇨🇿Prelouc, Czech Republic
Site Reference ID/Investigator# 44893
🇨🇿Slany, Czech Republic
Site Reference ID/Investigator# 40919
🇨🇿Smrzovka, Czech Republic
Site Reference ID/Investigator# 40814
🇨🇿Stare Mesto, Czech Republic
Site Reference ID/Investigator# 41121
🇨🇿Tabor, Czech Republic
Site Reference ID/Investigator# 41203
🇨🇿Tranovice, Czech Republic
Site Reference ID/Investigator# 40970
🇨🇿Trinec, Czech Republic
Site Reference ID/Investigator# 40895
🇨🇿Trutnov, Czech Republic
Site Reference ID/Investigator# 41104
🇨🇿Sternberk, Czech Republic
Site Reference ID/Investigator# 38746
🇨🇿Svitavy, Czech Republic
Site Ref # / Investigator 40955
🇨🇿Turnov, Czech Republic
Site Reference ID/Investigator# 40959
🇨🇿Uherske Hradiste, Czech Republic
Site Reference ID/Investigator# 41116
🇨🇿Usti nad Labem, Czech Republic
Site Reference ID/Investigator# 41186
🇨🇿Zdar nad Sazavou, Czech Republic
Site Reference ID/Investigator# 42084
🇨🇿Zdar nad Sazavou, Czech Republic
Site Reference ID/Investigator# 44895
🇨🇿Zlonice, Czech Republic
Site Reference ID/Investigator# 40971
🇨🇿Trinec, Czech Republic
Site Reference ID/Investigator# 40906
🇨🇿Usti nad Labem, Czech Republic
Site Reference ID/Investigator# 41105
🇨🇿Vyskov, Czech Republic
Site Ref # / Investigator 40958
🇨🇿Brno, Czech Republic
Site Reference ID/Investigator# 40811
🇨🇿Litomysl, Czech Republic
Site Reference ID/Investigator# 41106
🇨🇿Litvinov, Czech Republic
Site Reference ID/Investigator# 40904
🇨🇿Louny, Czech Republic
Site Reference ID/Investigator# 40953
🇨🇿Malsice, Czech Republic
Site Reference ID/Investigator# 40951
🇨🇿Ostrava, Czech Republic
Site Reference ID/Investigator# 40972
🇨🇿Ostrava, Czech Republic
Site Ref # / Investigator 40911
🇨🇿Prachatice, Czech Republic
Site Reference ID/Investigator# 40916
🇨🇿Zamberk, Czech Republic
Site Reference ID/Investigator# 40950
🇨🇿Valasske Mezirici, Czech Republic
Site Reference ID/Investigator# 40813
🇨🇿Vyskov, Czech Republic
Site Ref # / Investigator 41115
🇨🇿Zabreh, Czech Republic
Site Ref # / Investigator 38710
🇨🇿Ceske Budejovice, Czech Republic
Site Reference ID/Investigator# 41195
🇨🇿Bustehrad, Czech Republic
Site Ref # / Investigator 40902
🇨🇿Decin, Czech Republic
Site Reference ID/Investigator# 41117
🇨🇿Hadacka, Czech Republic
Site Reference ID/Investigator# 40808
🇨🇿Havirov,Ostrava, Czech Republic
Site Reference ID/Investigator# 41188
🇨🇿Hradec Kralove, Czech Republic
Site Reference ID/Investigator# 40816
🇨🇿Ostrava, Czech Republic
Site Reference ID/Investigator# 44886
🇨🇿Prague 3, Czech Republic