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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01621633
Eligibility Criteria:
Inclusion Criteria:
* All subjects:
* Male and female subjects aged 18-75 years.
* Body weight at least 55 kg with a body mass index between 18-35 kg/m2.
* Hepatic impairment subjects:
* Mild or moderate hepatic impairment.
Exclusion Criteria:
* All subjects:
* Clinical manifestations of postural symptomatic hypotension at screening or baseline.
* History of hypersensitivity to LCZ696 or to drugs of similar classes.
* Hepatic impairment subjects:
* Hepatic impairment due to non-liver disease.
* Treatment with any vasodilator, autonomic alpha blocker or beta2 agonist within 2 weeks of dosing.
* Encephalopathyy Stage III or IV.
* Primary biliary liver cirrhosis or biliary obstruction.
* History of gastro-intestinal bleeding within 3 months prior to screening.
* Healthy subjects:
* Any surgical or medical condition which might significantly alter the distribution, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
* Use of prescription drugs, herbal supplements, and/or over-the-counter medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01621633
Study Brief:
Protocol Section:
NCT01621633