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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01996618
Eligibility Criteria:
Inclusion Criteria:
* Subjects male and female 18 years and older
* Symptoms of palpitations
* Greater than or equal to 1,000 Ventricular Premature Beats during 24-hour electrocardiographic monitoring
* Completion of a consent form prior to pre-randomization Holter monitor
Exclusion Criteria:
* Moderate to severe symptomatic heart failure, New York Heart Association Class III/IV
* Moderate to severe symptomatic angina, Canadian Cardiovascular Classification III/IV
* Moderate to severe structural heart disease in the absence of an implantable cardiac defibrillator in a subject who would otherwise be eligible for a defibrillator (e.g. history of myocardial infarction and a left ventricular ejection fraction less than 30%)
* Clinically significant hepatic disease (cirrhosis or chronic hepatitis) or abnormal liver associated enzymes greater than three times the upper limits of normal
* A baseline corrected QT interval greater than or equal to 500msec or history of congenital channelopathy (long QT syndrome, Brugada syndrome) or torsades de pointes.
* Treatment with agents known to prolong the QTc interval
* Treatment with agents that are potent or moderately potent inhibitors of CYP3A, to include, but is not limited to the following: ketoconazole, HIV protease inhibitors (i.e. ritonavir), macrolide antibiotics (i.e. clarithromycin), diltiazem and verapamil
* Females who are pregnant, planning to get pregnant, or breast feeding ( females under the age of 55 years who have not previously undergone surgical sterilization procedures will have serum qualitative pregnancy testing)
* Thyroid stimulating hormone less than 0.27 IU/mL
* Serum magnesium less than 1.5mg/dL
* Serum potassium less than 3.5 mEq/dL or greater than 5.0 mEq/dL
* Estimated GFR less than 30 mL/min
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01996618
Study Brief:
Protocol Section:
NCT01996618