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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT02784535
Eligibility Criteria:
Inclusion Criteria:
* 40 years old or older
* Neurogenic Orthostatic Hypotension (defined by a reduction of ≥20 mmHg drop in SBP within 3 minutes of standing, associated with impaired autonomic reflexes as assessed by autonomic function tests.
Exclusion Criteria:
* Pregnancy or breastfeeding
* Hypersensitivity to atomoxetine (severe allergic reaction, rash, urticaria, anaphylaxis)
* Use of other norepinephrine transporter inhibitors such as Wellbutrin (Bupropion), Cymbalta (Duloxetine), Effexor (venlafaxine), Pristiq (desvenlafaxine), Savella (milnacipran)
* Previous history (within 14 days prior to enrollment) and current use of monoamine oxidase inhibitors
* Concomitant use of strong CYP2D6 inhibitors such as delavirdine, paroxetine, fluoxetine, quinidine
* Pre-existing sustained severe hypertension (BP ≥ 140/80 mmhg in the sitting position)
* Impaired hepatic function (aspartate amino transaminase \[AST\] and/or alanine amino transaminase \[ALT\] \>2 x upper limit of normal range)
* Impaired renal function (serum creatinine equal or more than 1.6 mg/dl)
* Myocardial infarction within 6 months prior to enrollment
* Congestive heart failure (LV hypertrophy acceptable)
* History of serious neurologic disease such as cerebral hemorrhage, or stroke
* Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, unlikelihood of completing the study, and mental conditions rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Narrow-angle glaucoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT02784535
Study Brief:
Protocol Section:
NCT02784535