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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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®. |
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| Measure | Description | Time Frame |
|---|---|---|
| Compliance With Tarka Treatment, All Participants and by Gender. | 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. | Participants were asked how many doses of Tarka they had missed since their previous visit. | Month 6 Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg
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| Name | Affiliation | Role |
|---|---|---|
| Adam Hloska, M.D. | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 44896 | Babice | 68703 | Czechia | |||
| Site Reference ID/Investigator# 40910 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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®. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | 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 | 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 | 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 | 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 |
| Beroun |
| 26601 |
| Czechia |
| Site Reference ID/Investigator# 40908 | Bílovec | 74301 | Czechia |
| Site Reference ID/Investigator# 38816 | Blansko | 678 01 | Czechia |
| Site Reference ID/Investigator# 41189 | Brandýs nad Labem | 25001 | Czechia |
| Site Ref # / Investigator 40958 | Brno | 602 00 | Czechia |
| Site Reference ID/Investigator# 40821 | Brno | 602 00 | Czechia |
| Site Reference ID/Investigator# 40944 | Brno | 602 00 | Czechia |
| Site Reference ID/Investigator# 41112 | Brno | 602 00 | Czechia |
| Site Reference ID/Investigator# 41187 | Brno | 602 00 | Czechia |
| Site Reference ID/Investigator# 41196 | Brno | 602 00 | Czechia |
| Site Reference ID/Investigator# 44887 | Brno | 60200 | Czechia |
| Site Reference ID/Investigator# 42083 | Brumov | 76331 | Czechia |
| Site Reference ID/Investigator# 40967 | Bruntál | 564 21 | Czechia |
| Site Reference ID/Investigator# 40918 | Břeclav | 690 02 | Czechia |
| Site Reference ID/Investigator# 41119 | Buštěhrad | 273 43 | Czechia |
| Site Reference ID/Investigator# 41195 | Buštěhrad | 273 43 | Czechia |
| Site Reference ID/Investigator# 38836 | Bystřice nad Pernštejnem | 593 01 | Czechia |
| Site Reference ID/Investigator# 41190 | Bystřice nad Pernštejnem | 593 01 | Czechia |
| Site Ref # / Investigator 41626 | C. Trebova | 779 00 | Czechia |
| Site Reference ID/Investigator# 42082 | Cheb | 35002 | Czechia |
| Site Reference ID/Investigator# 41191 | České Budějovice | 323 00 | Czechia |
| Site Ref # / Investigator 38710 | České Budějovice | 370 01 | Czechia |
| Site Reference ID/Investigator# 40948 | České Budějovice | 370 01 | Czechia |
| Site Reference ID/Investigator# 40960 | České Budějovice | 370 01 | Czechia |
| Site Reference ID/Investigator# 40914 | České Budějovice | 37001 | Czechia |
| Site Reference ID/Investigator# 57305 | České Budějovice | 37001 | Czechia |
| Site Reference ID/Investigator# 38886 | Děčín | 405 02 | Czechia |
| Site Reference ID/Investigator# 41110 | Děčín | 405 02 | Czechia |
| Site Reference ID/Investigator# 40818 | Děčín | 40501 | Czechia |
| Site Reference ID/Investigator# 40897 | Děčín | 40502 | Czechia |
| Site Ref # / Investigator 40902 | Děčín | 40505 | Czechia |
| Site Reference ID/Investigator# 41117 | Hadačka | 33141 | Czechia |
| Site Reference ID/Investigator# 40808 | Havirov,Ostrava | 702 00 | Czechia |
| Site Reference ID/Investigator# 41103 | Havířov | 736 01 | Czechia |
| Site Reference ID/Investigator# 40909 | Horní Slavkov | 35731 | Czechia |
| Site Reference ID/Investigator# 41185 | Hradec Králové | 500 02 | Czechia |
| Site Reference ID/Investigator# 41188 | Hradec Králové | 500 02 | Czechia |
| Site Reference ID/Investigator# 41197 | Hranice | 753 01 | Czechia |
| Site Reference ID/Investigator# 40805 | Hranice | 753 22 | Czechia |
| Site Reference ID/Investigator# 40815 | Hranice U Asa | 354 15 | Czechia |
| Site Reference ID/Investigator# 38736 | Jihlava | 586 01 | Czechia |
| Site Reference ID/Investigator# 38844 | Karlovy Vary | 360 01 | Czechia |
| Site Reference ID/Investigator# 41184 | Kdyně | 34 506 | Czechia |
| Site Reference ID/Investigator# 41113 | Kladno | 272 01 | Czechia |
| Site Ref # / Investigator 44894 | Kladno | 27280 | Czechia |
| Site Reference ID/Investigator# 40905 | Kopřivnice | 74221 | Czechia |
| Site Ref # / Investigator 40961 | Krnov | 779 00 | Czechia |
| Site Reference ID/Investigator# 40901 | Kunovice | 68604 | Czechia |
| Site Reference ID/Investigator# 41192 | Kutná Hora | 284 01 | Czechia |
| Site Reference ID/Investigator# 40811 | Litomyšl | 570 01 | Czechia |
| Site Reference ID/Investigator# 41106 | Litvínov | 43601 | Czechia |
| Site Reference ID/Investigator# 40904 | Louny | 44001 | Czechia |
| Site Reference ID/Investigator# 40969 | Lovosice | 41002 | Czechia |
| Site Reference ID/Investigator# 40953 | Malšice | 370 01 | Czechia |
| Site Reference ID/Investigator# 41204 | Mladá Boleslav | 293 60 | Czechia |
| Site Ref # / Investigator 44882 | Mladá Boleslav | 29301 | Czechia |
| Site Reference ID/Investigator# 40804 | Mnichovo Hradiště | 295 01 | Czechia |
| Site Ref # / Investigator 41118 | Nový Jičín | 741 01 | Czechia |
| Site Reference ID/Investigator# 40954 | Nový Jičín | 741 01 | Czechia |
| Site Ref # / Investigator 38569 | Nymburk | 288 02 | Czechia |
| Site Reference ID/Investigator# 41114 | Olomouc | 772 00 | Czechia |
| Site Reference ID/Investigator# 40949 | Olomouc | 781 01 | Czechia |
| Site Reference ID/Investigator# 41107 | Olomouc | 783 13 | Czechia |
| Site Ref # / Investigator 40907 | Olomouc | 79401 | Czechia |
| Site Reference ID/Investigator# 41202 | Orlová | 735 14 | Czechia |
| Site Reference ID/Investigator# 40816 | Ostrava | 700 30 | Czechia |
| Site Reference ID/Investigator# 40951 | Ostrava | 702 00 | Czechia |
| Site Reference ID/Investigator# 40972 | Ostrava | 702 00 | Czechia |
| Site Reference ID/Investigator# 41194 | Ostrava | 702 00 | Czechia |
| Site Reference ID/Investigator# 40968 | Ostrava | 708 52 | Czechia |
| Site Reference ID/Investigator# 40945 | Pardubice | 530 02 | Czechia |
| Site Reference ID/Investigator# 40957 | Pardubice | 530 03 | Czechia |
| Site Reference ID/Investigator# 41201 | Pardubice | 530 03 | Czechia |
| Site Reference ID/Investigator# 41205 | Pardubice | 530 03 | Czechia |
| Site Reference ID/Investigator# 41625 | Pardubice | 530 03 | Czechia |
| Site Reference ID/Investigator# 40956 | Pilsen | 320 00 | Czechia |
| Site Reference ID/Investigator# 40896 | Pilsen | 320 01 | Czechia |
| Site Ref # / Investigator 46282 | Pilsen | 32000 | Czechia |
| Site Reference ID/Investigator# 40900 | Plasy | 33101 | Czechia |
| Site Reference ID/Investigator# 41111 | Poděbrady | 290 01 | Czechia |
| Site Ref # / Investigator 40911 | Prachatice | 34142 | Czechia |
| Site Reference ID/Investigator# 41120 | Prague | 110 00 | Czechia |
| Site Reference ID/Investigator# 41108 | Prague | 120 00 | Czechia |
| Site Reference ID/Investigator# 40822 | Prague | 128 08 | Czechia |
| Site Reference ID/Investigator# 44886 | Prague | 13000 | Czechia |
| Site Ref # / Investigator 40819 | Prague | 140 00 | Czechia |
| Site Reference ID/Investigator# 40817 | Prague | 140 00 | Czechia |
| Site Reference ID/Investigator# 40812 | Prague | 149 00 | Czechia |
| Site Reference ID/Investigator# 38628 | Prague | 150 00 | Czechia |
| Site Reference ID/Investigator# 44883 | Prague | 15000 | Czechia |
| Site Reference ID/Investigator# 41193 | Prague | 160 00 | Czechia |
| Site Reference ID/Investigator# 44884 | Prague | 16000 | Czechia |
| Site Reference ID/Investigator# 40917 | Prague | 169 00 | Czechia |
| Site Reference ID/Investigator# 40913 | Prague | 180 00 | Czechia |
| Site Reference ID/Investigator# 41123 | Prague | 180 00 | Czechia |
| Site Reference ID/Investigator# 41124 | Prague | 180 00 | Czechia |
| Site Reference ID/Investigator# 40903 | Prague | 18000 | Czechia |
| Site Reference ID/Investigator# 38630 | Prague | 190 00 | Czechia |
| Site Reference ID/Investigator# 40802 | Prague | 190 00 | Czechia |
| Site Reference ID/Investigator# 40823 | Prague | Czechia |
| Site Reference ID/Investigator# 41126 | Přelouč | 535 01 | Czechia |
| Site Reference ID/Investigator# 41198 | Přelouč | 535 01 | Czechia |
| Site Reference ID/Investigator# 40809 | Příbram | 26101 | Czechia |
| Site Reference ID/Investigator# 40952 | Rokycany | 337 22 | Czechia |
| Site Reference ID/Investigator# 44893 | Slaný | 274 01 | Czechia |
| Site Reference ID/Investigator# 41109 | Slatiňany | 538 21 | Czechia |
| Site Reference ID/Investigator# 40919 | Smržovka | 468 51 | Czechia |
| Site Ref # / Investigator 40807 | Stará Paka | 507 91 | Czechia |
| Site Reference ID/Investigator# 40814 | Staré Město | 686 03 | Czechia |
| Site Reference ID/Investigator# 42085 | Staré Město | 68601 | Czechia |
| Site Reference ID/Investigator# 41104 | Sternberk | 779 99 | Czechia |
| Site Reference ID/Investigator# 38746 | Svitavy | 568 02 | Czechia |
| Site Reference ID/Investigator# 41121 | Tábor | 370 01 | Czechia |
| Site Ref # / Investigator 40820 | Teplice | 41501 | Czechia |
| Site Reference ID/Investigator# 40895 | Trutnov | 54121 | Czechia |
| Site Reference ID/Investigator# 41203 | Třanovice | 739 53 | Czechia |
| Site Reference ID/Investigator# 38739 | Třebíč | 674 01 | Czechia |
| Site Reference ID/Investigator# 40970 | Třinec | 739 61 | Czechia |
| Site Reference ID/Investigator# 40971 | Třinec | 739 61 | Czechia |
| Site Reference ID/Investigator# 41200 | Třinec | 739 61 | Czechia |
| Site Ref # / Investigator 40955 | Turnov | 511 01 | Czechia |
| Site Reference ID/Investigator# 40959 | Uherské Hradiště | 686 01 | Czechia |
| Site Reference ID/Investigator# 41182 | Uherské Hradiště | 686 01 | Czechia |
| Site Reference ID/Investigator# 40906 | Ústí nad Labem | 40001 | Czechia |
| Site Reference ID/Investigator# 41116 | Ústí nad Labem | 40007 | Czechia |
| Site Reference ID/Investigator# 40950 | Valašské Meziříčí | 757 01 | Czechia |
| Site Reference ID/Investigator# 40813 | Vyškov | 682 01 | Czechia |
| Site Reference ID/Investigator# 41105 | Vyškov | 682 01 | Czechia |
| Site Ref # / Investigator 41115 | Zábřeh | 560 02 | Czechia |
| Site Reference ID/Investigator# 41186 | Zdar | 591 01 | Czechia |
| Site Reference ID/Investigator# 42084 | Zdar | 591 01 | Czechia |
| Site Reference ID/Investigator# 44895 | Zlonice | 27371 | Czechia |
| Site Reference ID/Investigator# 40916 | Žamberk | 789 01 | Czechia |
| Number of Participants Analyzed |
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| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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®. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compliance With Tarka Treatment, All Participants and by Gender. | Participants were asked how many doses of Tarka they had missed after three months of treatment. | All participants with evaluable case report forms were analyzed. | Posted | Number | participants | Month 3 Visit |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | The mean (average) change in participants' systolic blood pressure and diastolic blood pressure from the baseline visit to the Month 6 visit. | This analysis included all participants with complete data for the entire study. | Posted | Mean | Standard Deviation | mmHg | Baseline to Month 6 Visit |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving Blood Pressure < 140/90 mmHg | The percentage of patients who had achieved blood pressure less than 140/90 mmHg after three months of treatment. | This analysis included all participants with complete data for the entire study. | Posted | Number | Percentage of participants | Month 3 Visit |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving Blood Pressure < 140/90 mmHg | The percentage of patients who had achieved blood pressure less than 140/90 mmHg after six months of treatment. | This analysis included all participants with complete data for the entire study. | Posted | Number | Percentage of participants | Month 6 Visit |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal | 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. | This analysis included all participants with complete data for the entire study. | Posted | Number | Participants | Month 3 Visit |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Compliance With Tarka Treatment, All Participants and by Gender. | Participants were asked how many doses of Tarka they had missed since their previous visit. | All participants with evaluable case report forms were analyzed. | Posted | Number | participants | Month 6 Visit |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal | 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. | This analysis included all participants with complete data for the entire study. | Posted | Number | Participants | Month 6 Visit |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Adverse Events Leading to Study Discontinuation | The number of participants who discontinued from the study due to an adverse event and reported event descriptions are summarized. | All participants with case report forms were included in this analysis. | Posted | Number | Participants | Baseline to Month 6 Visit |
|
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Participants were followed for a period of 6 months or until discontinuation of treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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®. | 0 | 3,828 | 0 | 3,828 |
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Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Missed two doses |
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| Missed more than 2 doses |
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