NOCDURNA Cohort
OtherNon intervention
NCT Number: NCT04740645
A study using medical records to evaluate safety issues for the NOCDURNA drug using national register data from Denmark and Sweden, and a health care register covering parts of Germany.
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Notify Me18 year and older
All sexes
Observational
Danish Health Care Registry, Copenhagen, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non intervention
Non intervention
Time frame: Through study completion, typically 2 months
Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia.
Time frame: Through study completion, typically 2 months
Hyponatraemia requiring hospital intensive care was defined as a primary or secondary diagnosis of hyponatraemia recorded in an intensive care unit.
Time frame: Through study completion, typically 2 months
Clinically significant hyponatraemia was defined as a serum sodium concentration of <130 mmol/L. Severity of hyponatraemia was categorized as mild hyponatraemia (serum sodium concentration: 130 to <135 mmol/L), moderate hyponatraemia (serum sodium concentration: >125 to <130 mmol/L) and severe hyponatraemia (serum sodium concentration: less than equal to [≤]125 mmol/L).
Time frame: Through study completion, typically 2 months
All-cause mortality was defined as death from any cause.
Time frame: Through study completion, typically 2 months
Major adverse cardiovascular events were defined as a record of myocardial infarction and stroke. Fatal and non-fatal events will be considered separately.
Time frame: Through study completion, typically 2 months
Venous thromboembolic events were defined as a record of a deep vein thrombosis, pulmonary embolism or portal vein thrombosis. Fatal and non-fatal events will be considered separately.
Time frame: Through study completion, typically 2 months
Acute exacerbation of congestive heart failure was defined as primary diagnosis of acute or acute-on-chronic heart failure from hospital inpatient care or the acute and emergency ward, or death from heart failure as the underlying or contributory cause.
Time frame: Through study completion, typically 2 months
Ferring Pharmaceuticals
Industry
Post-authorisation Safety Study of NOCDURNA for the Symptomatic Treatment of Nocturia Due to Idiopathic Nocturnal Polyuria: A Multi-country Cohort Study Using Secondary Data
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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