N/A
N=3,828
Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With Tarka® Fixed Combination in Patients With Essential Hypertension
Essential Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01127139 ↗Enrolled (actual)
3,828
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Compliance With Tarka Treatment, All Participants and by Gender. — 2190; 1141; 1049; 1095 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compliance With Tarka Treatment, All Participants and by Gender. |
2239; 1181; 1058; 901; 420; 481 | — |
| PRIMARY Compliance With Tarka Treatment, All Participants and by Gender. |
2239; 1181; 1058; 901; 420; 481 | — |
| SECONDARY Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
-28.28; -16.39 | — |
| SECONDARY Percentage of Patients Achieving Blood Pressure < 140/90 mmHg |
64.5 | — |
| SECONDARY Percentage of Patients Achieving Blood Pressure < 140/90 mmHg |
64.5 | — |
| SECONDARY Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal |
13; 4; 2; 2; 23; 1 | — |
| SECONDARY Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal |
13; 4; 2; 2; 23; 1 | — |
| SECONDARY Adverse Events Leading to Study Discontinuation |
40; 1; 2; 1; 1; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01127139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.