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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127139
• Other study ID #: P12-161
• Status: Completed
• Phase: N/A
• First received: May 19, 2010
• Last updated: March 30, 2012
• Start date: April 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3828
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Locations

Country	Name	City	State
Czech Republic	Site Reference ID/Investigator# 44896	Babice
Czech Republic	Site Reference ID/Investigator# 40910	Beroun
Czech Republic	Site Reference ID/Investigator# 40908	Bilovec
Czech Republic	Site Reference ID/Investigator# 38816	Blansko
Czech Republic	Site Reference ID/Investigator# 41189	Brandys nad Labem
Czech Republic	Site Reference ID/Investigator# 40918	Breclav
Czech Republic	Site Ref # / Investigator 40958	Brno
Czech Republic	Site Reference ID/Investigator# 40821	Brno
Czech Republic	Site Reference ID/Investigator# 40944	Brno
Czech Republic	Site Reference ID/Investigator# 41112	Brno
Czech Republic	Site Reference ID/Investigator# 41187	Brno
Czech Republic	Site Reference ID/Investigator# 41196	Brno
Czech Republic	Site Reference ID/Investigator# 44887	Brno
Czech Republic	Site Reference ID/Investigator# 42083	Brumov
Czech Republic	Site Reference ID/Investigator# 40967	Bruntal
Czech Republic	Site Reference ID/Investigator# 41119	Bustehrad
Czech Republic	Site Reference ID/Investigator# 41195	Bustehrad
Czech Republic	Site Reference ID/Investigator# 38836	Bystrice nad Pernstejnem
Czech Republic	Site Reference ID/Investigator# 41190	Bystrice nad Pernstejnem
Czech Republic	Site Ref # / Investigator 41626	C. Trebova
Czech Republic	Site Ref # / Investigator 38710	Ceske Budejovice
Czech Republic	Site Reference ID/Investigator# 40914	Ceske Budejovice
Czech Republic	Site Reference ID/Investigator# 40948	Ceske Budejovice
Czech Republic	Site Reference ID/Investigator# 40960	Ceske Budejovice
Czech Republic	Site Reference ID/Investigator# 41191	Ceske Budejovice
Czech Republic	Site Reference ID/Investigator# 57305	Ceske Budejovice
Czech Republic	Site Reference ID/Investigator# 42082	Cheb
Czech Republic	Site Ref # / Investigator 40902	Decin
Czech Republic	Site Reference ID/Investigator# 38886	Decin
Czech Republic	Site Reference ID/Investigator# 40818	Decin
Czech Republic	Site Reference ID/Investigator# 40897	Decin
Czech Republic	Site Reference ID/Investigator# 41110	Decin
Czech Republic	Site Reference ID/Investigator# 41117	Hadacka
Czech Republic	Site Reference ID/Investigator# 41103	Havirov
Czech Republic	Site Reference ID/Investigator# 40808	Havirov,Ostrava
Czech Republic	Site Reference ID/Investigator# 40909	Horni Slavkov
Czech Republic	Site Reference ID/Investigator# 41185	Hradec Kralove
Czech Republic	Site Reference ID/Investigator# 41188	Hradec Kralove
Czech Republic	Site Reference ID/Investigator# 40805	Hranice
Czech Republic	Site Reference ID/Investigator# 41197	Hranice
Czech Republic	Site Reference ID/Investigator# 40815	Hranice u Asa
Czech Republic	Site Reference ID/Investigator# 38736	Jihlava
Czech Republic	Site Reference ID/Investigator# 38844	Karlovy Vary
Czech Republic	Site Reference ID/Investigator# 41184	Kdyne
Czech Republic	Site Ref # / Investigator 44894	Kladno
Czech Republic	Site Reference ID/Investigator# 41113	Kladno
Czech Republic	Site Reference ID/Investigator# 40905	Koprivnice
Czech Republic	Site Ref # / Investigator 40961	Krnov
Czech Republic	Site Reference ID/Investigator# 40901	Kunovice
Czech Republic	Site Reference ID/Investigator# 41192	Kutna Hora
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# 40969	Lovosice
Czech Republic	Site Reference ID/Investigator# 40953	Malsice
Czech Republic	Site Ref # / Investigator 44882	Mlada Boleslav
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# 40954	Novy Jicin
Czech Republic	Site Ref # / Investigator 38569	Nymburk
Czech Republic	Site Ref # / Investigator 40907	Olomouc
Czech Republic	Site Reference ID/Investigator# 40949	Olomouc
Czech Republic	Site Reference ID/Investigator# 41107	Olomouc
Czech Republic	Site Reference ID/Investigator# 41114	Olomouc
Czech Republic	Site Reference ID/Investigator# 41202	Orlova
Czech Republic	Site Reference ID/Investigator# 40816	Ostrava
Czech Republic	Site Reference ID/Investigator# 40951	Ostrava
Czech Republic	Site Reference ID/Investigator# 40968	Ostrava
Czech Republic	Site Reference ID/Investigator# 40972	Ostrava
Czech Republic	Site Reference ID/Investigator# 41194	Ostrava
Czech Republic	Site Reference ID/Investigator# 40945	Pardubice
Czech Republic	Site Reference ID/Investigator# 40957	Pardubice
Czech Republic	Site Reference ID/Investigator# 41201	Pardubice
Czech Republic	Site Reference ID/Investigator# 41205	Pardubice
Czech Republic	Site Reference ID/Investigator# 41625	Pardubice
Czech Republic	Site Reference ID/Investigator# 40900	Plasy
Czech Republic	Site Ref # / Investigator 46282	Plzen
Czech Republic	Site Reference ID/Investigator# 40896	Plzen
Czech Republic	Site Reference ID/Investigator# 40956	Plzen
Czech Republic	Site Reference ID/Investigator# 41111	Podebrady
Czech Republic	Site Ref # / Investigator 40911	Prachatice
Czech Republic	Site Reference ID/Investigator# 41120	Prague 10
Czech Republic	Site Reference ID/Investigator# 40822	Prague 2
Czech Republic	Site Reference ID/Investigator# 41108	Prague 2
Czech Republic	Site Reference ID/Investigator# 44886	Prague 3
Czech Republic	Site Ref # / Investigator 40819	Prague 4
Czech Republic	Site Reference ID/Investigator# 40812	Prague 4
Czech Republic	Site Reference ID/Investigator# 40817	Prague 4
Czech Republic	Site Reference ID/Investigator# 38628	Prague 5
Czech Republic	Site Reference ID/Investigator# 44883	Prague 5
Czech Republic	Site Reference ID/Investigator# 40917	Prague 6
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# 40913	Prague 8
Czech Republic	Site Reference ID/Investigator# 41123	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# 40802	Prague 9
Czech Republic	Site Reference ID/Investigator# 40823	Prague 9
Czech Republic	Site Reference ID/Investigator# 41126	Prelouc
Czech Republic	Site Reference ID/Investigator# 41198	Prelouc
Czech Republic	Site Reference ID/Investigator# 40809	Pribram
Czech Republic	Site Reference ID/Investigator# 40952	Rokycany
Czech Republic	Site Reference ID/Investigator# 44893	Slany
Czech Republic	Site Reference ID/Investigator# 41109	Slatinany
Czech Republic	Site Reference ID/Investigator# 40919	Smrzovka
Czech Republic	Site Ref # / Investigator 40807	Stara Paka
Czech Republic	Site Reference ID/Investigator# 40814	Stare Mesto
Czech Republic	Site Reference ID/Investigator# 42085	Stare Mesto
Czech Republic	Site Reference ID/Investigator# 41104	Sternberk
Czech Republic	Site Reference ID/Investigator# 38746	Svitavy
Czech Republic	Site Reference ID/Investigator# 41121	Tabor
Czech Republic	Site Ref # / Investigator 40820	Teplice
Czech Republic	Site Reference ID/Investigator# 41203	Tranovice
Czech Republic	Site Reference ID/Investigator# 38739	Trebic
Czech Republic	Site Reference ID/Investigator# 40970	Trinec
Czech Republic	Site Reference ID/Investigator# 40971	Trinec
Czech Republic	Site Reference ID/Investigator# 41200	Trinec
Czech Republic	Site Reference ID/Investigator# 40895	Trutnov
Czech Republic	Site Ref # / Investigator 40955	Turnov
Czech Republic	Site Reference ID/Investigator# 40959	Uherske Hradiste
Czech Republic	Site Reference ID/Investigator# 41182	Uherske Hradiste
Czech Republic	Site Reference ID/Investigator# 40906	Usti nad Labem
Czech Republic	Site Reference ID/Investigator# 41116	Usti nad Labem
Czech Republic	Site Reference ID/Investigator# 40950	Valasske Mezirici
Czech Republic	Site Reference ID/Investigator# 40813	Vyskov
Czech Republic	Site Reference ID/Investigator# 41105	Vyskov
Czech Republic	Site Ref # / Investigator 41115	Zabreh
Czech Republic	Site Reference ID/Investigator# 40916	Zamberk
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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Month 3 Visit	No
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.	Month 6 Visit	No
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.	Baseline to Month 6 Visit	No
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.	Month 3 Visit	No
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.	Month 6 Visit	No
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.	Month 3 Visit	No
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.	Month 6 Visit	No
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.	Baseline to Month 6 Visit	No