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 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT00970268
Eligibility Criteria:
Inclusion Criteria:
* Completion of a lead-in study (NCT00891462)
Exclusion Criteria:
* Use or anticipated use of any medication prohibited in this study
* Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
* The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
* QTcB of \>500 msec on both the pre-dose and post-dose ECG
* Women who are pregnant, intend to become pregnant, or are breast-feeding
* A life expectancy of less than 1 year
* Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
* Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00970268
Study Brief:
Protocol Section:
NCT00970268