Skip to main content
OpenTrials
Completed

NCT Number: NCT04740645

NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danish Health Care Registry, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Usage of NOCDURNA recorded as dispensations in adults or usage of drugs for LUTS.

Exclusion criteria

  • Multiple dispensations of NOCDURNA on the same day or treatment with vasopressin 6 months before study start.

Treatment and study plan

NOCDURNA Cohort

Other

Non intervention

LUTS Cohort

Other

Non intervention

Primary outcomes

  1. Incidence rate of symptomatic hyponatraemia

    Time frame: Through study completion, typically 2 months

    Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia.

Secondary outcomes

  1. Incidence rate of hyponatraemia requiring hospital intensive care

    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.

  2. Incidence and severity of clinically significant hyponatraemia

    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).

  3. Rate of all-cause mortality

    Time frame: Through study completion, typically 2 months

    All-cause mortality was defined as death from any cause.

  4. Incidence rate of major adverse cardiovascular events (MACE)

    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.

  5. Incidence rate of major venous thromboembolic events (VTEs)

    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.

  6. Incidence rate acute exacerbation of congestive heart failure

    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.

  7. Incidence of serious adverse events of MACE and VTE in Sweden

    Time frame: Through study completion, typically 2 months

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2021
Registry last updated
Dec 3, 2025

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.

Published trials that share one or more normalized conditions with this study.