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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT00882856
Eligibility Criteria:
Inclusion Criteria:
* Treated with clozapine \> 3 months and minimum 100 mg/day
* Fixed dose 14 days before inclusion
* Heart rate \> 100 (ECG)
* Pregnancy test negative
* Clozapine-induced sinustachycardia documented by ECG or case record
* Sexual abstinence or contraception
* Informed consent
Exclusion Criteria:
* Substance abuse
* Physical diseases, contraindications for clozapine or bisoprolol
* Asthma or chronic obstructive lung disease
* Blood pressure \< 100/60 or recent history of syncopes
* QTc\>500 ms, SA-block, AV- block II or III
* Restrictions by Danish mental act
* Allergic to clozapine or bisoprolol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00882856
Study Brief:
Protocol Section:
NCT00882856