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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT01044693
Eligibility Criteria:
Inclusion Criteria:
* Male or female and aged 18 years or over.
* Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure).
* A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing.
* Supine hypertension, defined as a systolic blood pressure \>150 mm Hg or diastolic blood pressure \> 90 mm Hg.
* Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.
Exclusion Criteria:
* Have changed dose, frequency and or type of prescribed medication, within two weeks of study start.
* Women of childbearing potential who are not using a medically accepted contraception.
* Have, in the investigator's opinion, any significant cardiac, systemic, hepatic, or renal illness.
* Diabetes mellitus or insipidus.
* In the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing.
* In the investigator's opinion, are unable to adequately co-operate because of individual or family situation.
* In the investigator's opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia.
* Are not able or willing to comply with the study requirements for the duration of the study.
* Persons on drugs with beta-blocking potential (e.g., amiodarone), persons taking scheduled or as needed nitrates and persons on drugs with alpha-blocking potential (e.g. tamsulosin).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01044693
Study Brief:
Protocol Section:
NCT01044693