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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT01083732
Eligibility Criteria:
Inclusion criteria:
1. males or females 1 to less than 12 years of age
2. objective diagnosis of primary VTE
3. completion of planned treatment course with LMWH or OAC for primary VTE
4. written informed consent by parent (legal guardian) and patient assent (if applicable)
Exclusion criteria:
1. weight less than 9 kg
2. conditions associated with increased risk of bleeding
3. patients who have any condition that would not allow safe participation in study Note: Further exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
11 Years
Study:
NCT01083732
Study Brief:
Protocol Section:
NCT01083732