Effectiveness and Tolerability of Tarka® in the Treatment of Hypertensive Patients With High Risk of Developing Diabetes Mellitus (TARDIA)

Abbott

Status: Completed

Conditions: Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT01079195

P10-299

Details and patient eligibility

About

The aim of this post-marketing observational study (PMOS) is to provide data on the effectiveness and tolerability of Tarka in patients with a high risk of developing diabetes mellitus, as prescribed by the physicians in a community setting and in accordance with the terms of the local marketing authorization. The following specific questions will be addressed:

• Effectiveness of Tarka in lowering the blood pressure in hypertensive patients being at high risk of developing diabetes, not controlled on single-drug therapy.
• Tolerability of Tarka as assessed by withdrawal rates.

Full description

This is a non-interventional, observational, open-label, multicountry, multicenter post-marketing study in which Tarka is prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication. Patients with a high risk of developing diabetes mellitus treated by secondary care specialists (such as internal medicine specialists, nephrologists, endocrinologists, etc.), whose hypertension is not controlled on single-drug therapy will be included.

The assignment of the patient to the treatment with Tarka is not decided in advance by this protocol but falls within current practice. The prescription of Tarka is clearly separated from the decision to include the patient in this study. No additional procedures (other than standard of care) shall be applied to the patients.

Each patient will be treated at the physician's discretion. Dosing schedule should be in the accordance with the locally approved Summary of Product Characteristics (SmPC). Physicians will be provided with a study kit that includes a protocol, Tarka's locally approved SmPC, and case reports forms for each patient to be enrolled.

The patient's demographic data, height, weight and waist circumference will be reported in the Inclusion visit. The previous antihypertensive therapy should be noted (generic name of the drug and total daily dose). All other drugs the patient currently receives for cardiovascular disease treatment should be recorded as well.

The patient will then be followed via regular office visits as determined by the physician. As this study is observational in nature, patient follow-up is not interventional and is left to the judgment of each physician within the 6-month period, which defines the survey for each patient. For indicative purposes, follow-up of participant should enable 3 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 commenced, and then "Follow-up visit Month 3 " and "Follow-up visit Month 6", although dates will depend only on the decision of the physician. As a result, failure to meet these suggested dates will not constitute a breach of the protocol.

Enrollment: 15,436 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients of either gender (more than 18 years of age), with established diagnosis of essential hypertension (systolic blood pressure/ diastolic blood pressure greater than 140/90 mmHg)

• Patients not controlled on single-drug therapy and decision was made to introduce Tarka

• Patients with a high risk of developing diabetes mellitus (defined according British Medical Society guidelines) with at least one of the following symptoms:

  • Positive family history of diabetes or
  • Obesity defined by a Body Mass Index (BMI) greater than 30 kg/m^2 or a waist circumference greater than 102 cm (males) or greater than 88 cm (females) or
  • Impaired fasting plasma glucose (FPG) levels of 6.1 to 7.0 mmol/l (100-126 mg/dl)

Exclusion criteria

• Patients with known or established Type 2 diabetes mellitus

• The use of Tarka is contraindicated in the following patients:

  • 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 angiotensin-converting enzyme (ACE) inhibitor
  • With severe renal or severe liver impairment
  • In pregnant women (women of childbearing potential who are unwilling to use contraception should not be included)
  • Lactating women

Trial design

15,436 participants in 1 patient group

Single Patient group with Hypertension

Description:

Single Patient group with Hypertension