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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01127139

Enrollment

3828

Registered

2010-05-20

Start date

2010-04-30

Completion date

2011-03-31

Last updated

2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

Essential hypertension

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Compliance With Tarka Treatment, All Participants and by Gender.	Month 3 Visit	Participants were asked how many doses of Tarka they had missed after three months of treatment.

Secondary

Measure	Time frame	Description
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 3 Visit	The percentage of patients who had achieved blood pressure less than 140/90 mmHg after three months of treatment.
Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal	Month 3 Visit	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.
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.

Countries

Czechia

Participant flow

Participants by arm

Arm	Count
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®.	3,828
Total	3,828

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	40
Overall Study	Incompliance	12
Overall Study	Lack of Efficacy	4
Overall Study	Reason not specified	1

Baseline characteristics

Characteristic	Czech Patients With Essential Hypertension
Age, Customized Age not reported	3828 Participants
Sex: Female, Male Female	1943 Participants
Sex: Female, Male Male	1885 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 3,828
serious Total, serious adverse events	0 / 3,828

Outcome results

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.

Time frame: Month 6 Visit

Population: All participants with evaluable case report forms were analyzed.

Arm	Measure	Group	Value (NUMBER)
Total	Compliance With Tarka Treatment, All Participants and by Gender.	Never missed a dose	2239 participants
Total	Compliance With Tarka Treatment, All Participants and by Gender.	Missed one dose	901 participants
Total	Compliance With Tarka Treatment, All Participants and by Gender.	Missed two doses	495 participants
Total	Compliance With Tarka Treatment, All Participants and by Gender.	Missed more than 2 doses	193 participants
Female Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Missed more than 2 doses	89 participants
Female Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Never missed a dose	1181 participants
Female Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Missed two doses	253 participants
Female Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Missed one dose	420 participants
Male Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Missed more than 2 doses	104 participants
Male Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Missed one dose	481 participants
Male Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Missed two doses	242 participants
Male Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Never missed a dose	1058 participants

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.

Time frame: Month 3 Visit

Population: All participants with evaluable case report forms were analyzed.

Arm	Measure	Group	Value (NUMBER)
Total	Compliance With Tarka Treatment, All Participants and by Gender.	Missed two doses	446 participants
Total	Compliance With Tarka Treatment, All Participants and by Gender.	Missed more than 2 doses	82 participants
Total	Compliance With Tarka Treatment, All Participants and by Gender.	Missed one dose	1095 participants
Total	Compliance With Tarka Treatment, All Participants and by Gender.	Never missed a dose	2190 participants
Female Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Never missed a dose	1141 participants
Female Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Missed one dose	548 participants
Female Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Missed more than 2 doses	41 participants
Female Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Missed two doses	213 participants
Male Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Missed more than 2 doses	56 participants
Male Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Never missed a dose	1049 participants
Male Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Missed one dose	547 participants
Male Participants	Compliance With Tarka Treatment, All Participants and by Gender.	Missed two doses	233 participants

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.

Time frame: Baseline to Month 6 Visit

Population: All participants with case report forms were included in this analysis.

Arm	Measure	Group	Value (NUMBER)
Total	Adverse Events Leading to Study Discontinuation	> Hypotension	3 Participants
Total	Adverse Events Leading to Study Discontinuation	> Constipation	6 Participants
Total	Adverse Events Leading to Study Discontinuation	> Dry cough	12 Participants
Total	Adverse Events Leading to Study Discontinuation	Total discontinued study due to an adverse event	40 Participants
Total	Adverse Events Leading to Study Discontinuation	> Face oedema	1 Participants
Total	Adverse Events Leading to Study Discontinuation	> Nausea	2 Participants
Total	Adverse Events Leading to Study Discontinuation	> Tremor	1 Participants
Total	Adverse Events Leading to Study Discontinuation	> Dyspepsia	1 Participants
Total	Adverse Events Leading to Study Discontinuation	> Feet oedema	2 Participants
Total	Adverse Events Leading to Study Discontinuation	> Allergic reaction	1 Participants
Total	Adverse Events Leading to Study Discontinuation	> Stomach hyperacidity	1 Participants
Total	Adverse Events Leading to Study Discontinuation	> Night cough	1 Participants
Total	Adverse Events Leading to Study Discontinuation	> Intolerance	3 Participants
Total	Adverse Events Leading to Study Discontinuation	> Tachycardia	2 Participants
Total	Adverse Events Leading to Study Discontinuation	> Not specified	1 Participants
Total	Adverse Events Leading to Study Discontinuation	> Hypertension	1 Participants
Total	Adverse Events Leading to Study Discontinuation	> Constipation + dry cough + hair loss	1 Participants
Total	Adverse Events Leading to Study Discontinuation	> Rash + palpitation	1 Participants

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.

Time frame: Baseline to Month 6 Visit