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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT02933034
Eligibility Criteria:
Inclusion Criteria:
All subjects to be entered must:
* be at least 18 years of age.
* if female, be nonpregnant as evidenced by a serum pregnancy test and using a medically-approved method of birth control, or post-menopausal or surgically sterile
* provide written informed consent after having received oral and written information about the study
* be in stable health based on medical history, examination and tests
Exclusion Criteria:
have a positive pregnancy test (females)
* received an investigational drug or device within 30 days prior to administration of SeeMore
* have known hypersensitivity to ondansetron or other selective serotonin 5HT3 receptor blockers
* have a history of drug abuse or alcoholism
* are taking a digitalis preparation or calcium channel blocker
* have a history of torsades or prolonged QT/QTc interval
* have NYHA Grade IV heart failure
* have abnormal liver function tests or a history of liver disease
* have uncontrolled hypertension (Systolic Blood Pressure \> 140 or Diastolic BP \> 90 consistently at baseline)
* have abnormal baseline potassium or calcium values or hemoglobin less than 10 g/dl
* are noncompliant or otherwise unlikely to perform as required by the protocol
* have pretest likelihood of CAD for which the requisite number of subjects have been entered
* develop an arrhythmia prior to or during either of the exercise tests; SeeMore should not be administered.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02933034
Study Brief:
Protocol Section:
NCT02933034