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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT00905593
Eligibility Criteria:
Inclusion Criteria:
* Having participated in Novartis study CAMN107A2109, and
* Written signed and dated informed consent prior to any study procedures being performed.
Exclusion Criteria:
* Impaired cardiac function,
* Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration; Other concurrent severe and/or uncontrolled medical conditions,
* Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval,
* patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days,
* Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control, OR
* Patients unwilling or unable to comply with the protocol.
Other protocol -defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00905593
Study Brief:
Protocol Section:
NCT00905593