Eligibility Module

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Eligibility Module

The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.

Eligibility Module path is as follows:

Study -> Protocol Section -> Eligibility Module

Eligibility Module

Ignite Creation Date: 2025-12-24 @ 1:33 PM
Ignite Modification Date: 2025-12-24 @ 1:33 PM
NCT ID: NCT01079195
Eligibility Criteria: 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
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT01079195
Study Brief:
Protocol Section: NCT01079195