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 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT01529294
Eligibility Criteria:
Inclusion Criteria:
* Inclusion criteria (all subjects):
* Caucasian subjects
* Inclusion criteria (hepatic impaired subjects):
* subjects with physical signs consistent with a clinical diagnosis of stable liver disease, which has been confirmed by imaging techniques, ultrasound, Magnetic Resonance Imaging or Computed Tomogram within 3 months of screening, and a creatinine clearance \> 50 mL/min (based on Cockroft and Gault formula).
* Inclusion criteria (healthy volunteers):
* good general health
* matched by age, gender, smoking status, Body Mass Index, and CYP2D6 phenotype to hepatic impaired subjects.
Exclusion Criteria:
* Exclusion criteria (all subjects):
* Subjects who report smoking a pipe, cigars or more than 20 cigarettes per day .
* History of drug abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening
* History of first-dose response/syncope to alpha1-blocking agents
* Exclusion criteria (Hepatic impaired subjects):
* Patients with symptoms or 6 months past history of encephalopathy.
* Patients with clinical evidence of moderate-severe ascites.
* Patients having a previous surgical porto-systemic shunt.
* Exclusion criteria (Healthy volunteers):
* History of alcohol abuse prior to dosing, or evidence of such abuse during screening.
* Pulse Rate \> 200 msec
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01529294
Study Brief:
Protocol Section:
NCT01529294