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

NCT ID: NCT01127139

Last Updated: 2012-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3828 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-03-31

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.

Conditions

Essential Hypertension

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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®.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Hloska, M.D.

Role: STUDY_DIRECTOR

Abbott

Locations

Site Reference ID/Investigator# 44896

Babice, , Czechia

Site Reference ID/Investigator# 40910

Beroun, , Czechia

Site Reference ID/Investigator# 40908

Bílovec, , Czechia

Site Reference ID/Investigator# 38816

Blansko, , Czechia

Site Reference ID/Investigator# 41189

Brandýs nad Labem, , Czechia

Site Ref # / Investigator 40958

Brno, , Czechia

Site Reference ID/Investigator# 40821

Brno, , Czechia

Site Reference ID/Investigator# 40944

Brno, , Czechia

Site Reference ID/Investigator# 41112

Brno, , Czechia

Site Reference ID/Investigator# 41187

Brno, , Czechia

Site Reference ID/Investigator# 41196

Brno, , Czechia

Site Reference ID/Investigator# 44887

Brno, , Czechia

Site Reference ID/Investigator# 42083

Brumov, , Czechia

Site Reference ID/Investigator# 40967

Bruntál, , Czechia

Site Reference ID/Investigator# 40918

Břeclav, , Czechia

Site Reference ID/Investigator# 41119

Buštěhrad, , Czechia

Site Reference ID/Investigator# 41195

Buštěhrad, , Czechia

Site Reference ID/Investigator# 38836

Bystřice nad Pernštejnem, , Czechia

Site Reference ID/Investigator# 41190

Bystřice nad Pernštejnem, , Czechia

Site Ref # / Investigator 41626

C. Trebova, , Czechia

Site Reference ID/Investigator# 42082

Cheb, , Czechia

Site Reference ID/Investigator# 41191

České Budějovice, , Czechia

Site Ref # / Investigator 38710

České Budějovice, , Czechia

Site Reference ID/Investigator# 40948

České Budějovice, , Czechia

Site Reference ID/Investigator# 40960

České Budějovice, , Czechia

Site Reference ID/Investigator# 40914

České Budějovice, , Czechia

Site Reference ID/Investigator# 57305

České Budějovice, , Czechia

Site Reference ID/Investigator# 38886

Děčín, , Czechia

Site Reference ID/Investigator# 41110

Děčín, , Czechia

Site Reference ID/Investigator# 40818

Děčín, , Czechia

Site Reference ID/Investigator# 40897

Děčín, , Czechia

Site Ref # / Investigator 40902

Děčín, , Czechia

Site Reference ID/Investigator# 41117

Hadačka, , Czechia

Site Reference ID/Investigator# 40808

Havirov,Ostrava, , Czechia

Site Reference ID/Investigator# 41103

Havířov, , Czechia

Site Reference ID/Investigator# 40909

Horní Slavkov, , Czechia

Site Reference ID/Investigator# 41185

Hradec Králové, , Czechia

Site Reference ID/Investigator# 41188

Hradec Králové, , Czechia

Site Reference ID/Investigator# 41197

Hranice, , Czechia

Site Reference ID/Investigator# 40805

Hranice, , Czechia

Site Reference ID/Investigator# 40815

Hranice U Asa, , Czechia

Site Reference ID/Investigator# 38736

Jihlava, , Czechia

Site Reference ID/Investigator# 38844

Karlovy Vary, , Czechia

Site Reference ID/Investigator# 41184

Kdyně, , Czechia

Site Reference ID/Investigator# 41113

Kladno, , Czechia

Site Ref # / Investigator 44894

Kladno, , Czechia

Site Reference ID/Investigator# 40905

Kopřivnice, , Czechia

Site Ref # / Investigator 40961

Krnov, , Czechia

Site Reference ID/Investigator# 40901

Kunovice, , Czechia

Site Reference ID/Investigator# 41192

Kutná Hora, , Czechia

Site Reference ID/Investigator# 40811

Litomyšl, , Czechia

Site Reference ID/Investigator# 41106

Litvínov, , Czechia

Site Reference ID/Investigator# 40904

Louny, , Czechia

Site Reference ID/Investigator# 40969

Lovosice, , Czechia

Site Reference ID/Investigator# 40953

Malšice, , Czechia

Site Reference ID/Investigator# 41204

Mladá Boleslav, , Czechia

Site Ref # / Investigator 44882

Mladá Boleslav, , Czechia

Site Reference ID/Investigator# 40804

Mnichovo Hradiště, , Czechia

Site Ref # / Investigator 41118

Nový Jičín, , Czechia

Site Reference ID/Investigator# 40954

Nový Jičín, , Czechia

Site Ref # / Investigator 38569

Nymburk, , Czechia

Site Reference ID/Investigator# 41114

Olomouc, , Czechia

Site Reference ID/Investigator# 40949

Olomouc, , Czechia

Site Reference ID/Investigator# 41107

Olomouc, , Czechia

Site Ref # / Investigator 40907

Olomouc, , Czechia

Site Reference ID/Investigator# 41202

Orlová, , Czechia

Site Reference ID/Investigator# 40816

Ostrava, , Czechia

Site Reference ID/Investigator# 40951

Ostrava, , Czechia

Site Reference ID/Investigator# 40972

Ostrava, , Czechia

Site Reference ID/Investigator# 41194

Ostrava, , Czechia

Site Reference ID/Investigator# 40968

Ostrava, , Czechia

Site Reference ID/Investigator# 40945

Pardubice, , Czechia

Site Reference ID/Investigator# 40957

Pardubice, , Czechia

Site Reference ID/Investigator# 41201

Pardubice, , Czechia

Site Reference ID/Investigator# 41205

Pardubice, , Czechia

Site Reference ID/Investigator# 41625

Pardubice, , Czechia

Site Reference ID/Investigator# 40956

Pilsen, , Czechia

Site Reference ID/Investigator# 40896

Pilsen, , Czechia

Site Ref # / Investigator 46282

Pilsen, , Czechia

Site Reference ID/Investigator# 40900

Plasy, , Czechia

Site Reference ID/Investigator# 41111

Poděbrady, , Czechia

Site Ref # / Investigator 40911

Prachatice, , Czechia

Site Reference ID/Investigator# 41120

Prague, , Czechia

Site Reference ID/Investigator# 41108

Prague, , Czechia

Site Reference ID/Investigator# 40822

Prague, , Czechia

Site Reference ID/Investigator# 44886

Prague, , Czechia

Site Ref # / Investigator 40819

Prague, , Czechia

Site Reference ID/Investigator# 40817

Prague, , Czechia

Site Reference ID/Investigator# 40812

Prague, , Czechia

Site Reference ID/Investigator# 38628

Prague, , Czechia

Site Reference ID/Investigator# 44883

Prague, , Czechia

Site Reference ID/Investigator# 41193

Prague, , Czechia

Site Reference ID/Investigator# 44884

Prague, , Czechia

Site Reference ID/Investigator# 40917

Prague, , Czechia

Site Reference ID/Investigator# 40913

Prague, , Czechia

Site Reference ID/Investigator# 41123

Prague, , Czechia

Site Reference ID/Investigator# 41124

Prague, , Czechia

Site Reference ID/Investigator# 40903

Prague, , Czechia

Site Reference ID/Investigator# 38630

Prague, , Czechia

Site Reference ID/Investigator# 40802

Prague, , Czechia

Site Reference ID/Investigator# 40823

Prague, , Czechia

Site Reference ID/Investigator# 41126

Přelouč, , Czechia

Site Reference ID/Investigator# 41198

Přelouč, , Czechia

Site Reference ID/Investigator# 40809

Příbram, , Czechia

Site Reference ID/Investigator# 40952

Rokycany, , Czechia

Site Reference ID/Investigator# 44893

Slaný, , Czechia

Site Reference ID/Investigator# 41109

Slatiňany, , Czechia

Site Reference ID/Investigator# 40919

Smržovka, , Czechia

Site Ref # / Investigator 40807

Stará Paka, , Czechia

Site Reference ID/Investigator# 40814

Staré Město, , Czechia

Site Reference ID/Investigator# 42085

Staré Město, , Czechia

Site Reference ID/Investigator# 41104

Sternberk, , Czechia

Site Reference ID/Investigator# 38746

Svitavy, , Czechia

Site Reference ID/Investigator# 41121

Tábor, , Czechia

Site Ref # / Investigator 40820

Teplice, , Czechia

Site Reference ID/Investigator# 41203

Tranovice, , Czechia

Site Reference ID/Investigator# 40895

Trutnov, , Czechia

Site Reference ID/Investigator# 38739

Třebíč, , Czechia

Site Reference ID/Investigator# 40970

Třinec, , Czechia

Site Reference ID/Investigator# 40971

Třinec, , Czechia

Site Reference ID/Investigator# 41200

Třinec, , Czechia

Site Ref # / Investigator 40955

Turnov, , Czechia

Site Reference ID/Investigator# 40959

Uherské Hradiště, , Czechia

Site Reference ID/Investigator# 41182

Uherské Hradiště, , Czechia

Site Reference ID/Investigator# 40906

Ústí nad Labem, , Czechia

Site Reference ID/Investigator# 41116

Ústí nad Labem, , Czechia

Site Reference ID/Investigator# 40950

Valašské Meziříčí, , Czechia

Site Reference ID/Investigator# 40813

Vyškov, , Czechia

Site Reference ID/Investigator# 41105

Vyškov, , Czechia

Site Ref # / Investigator 41115

Zábřeh, , Czechia

Site Reference ID/Investigator# 41186

Zdar, , Czechia

Site Reference ID/Investigator# 42084

Zdar, , Czechia

Site Reference ID/Investigator# 44895

Zlonice, , Czechia

Site Reference ID/Investigator# 40916

Žamberk, , Czechia

Countries

Czechia

Other Identifiers

P12-161

Identifier Type: -

Identifier Source: org_study_id