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NCT Number: NCT02545101

An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH

This is a retrospective chart review non-interventional study designed to collect real world data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone (SIADH) secretion.

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Key information

Conditions

Hyponatremia Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hypothalamic Diseases Inappropriate ADH Syndrome Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pituitary Diseases Syndrome of Inappropriate ADH (SIADH) Secretion Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bochum, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of patient informed consent unless a) not required by local regulations, b) it would take a non reasonable effort or c) if the source patient is deceased or untraceable.
  • Female and/or male patients aged 18 years and over.
  • Patients who received at least 2 doses of tolvaptan, for the treatment of one occurrence of hyponatraemia secondary to SIADH.

Exclusion criteria

  • A patient cannot take part in this study if participating in any other clinical study in which the medicinal product aims to treat the causes or symptoms of hyponatraemia at the time of the hyponatraemia episode being documented in the current study.

Treatment and study plan

Primary outcomes

  1. Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge

    Time frame: From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment)

    The primary variable of the study was the change in sodium levels from baseline to discharge or the final available measurement for patients who were not discharged (up to 6 weeks after treatment initiation).

Secondary outcomes

  1. Change in Sodium Levels 24 Hours After Treatment Initiation

    Time frame: From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards

    Change in sodium level from last value prior to receiving tolvaptan until last available measurement within 24 hours of initiation of tolvaptan

  2. Change in Sodium Levels 6 Weeks After Treatment Initiation

    Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards

    Change in sodium level from last value prior to receiving tolvaptan until last available measurement up to week 6

  3. Time (Hours) to Sodium Normalisation

    Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards

    Time (hours) to sodium normalisation, defined as a serum sodium level > 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation).

  4. Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,)

    Time frame: Baseline

    Primary disease diagnoses leading to SIADH by evaluation of diagnosis information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records

  5. Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population)

    Time frame: Baseline

    symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records

  6. Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,)

    Time frame: Baseline

    specialty of the clinician prescribing tolvaptan by evaluation of details of the physician who prescribed tolvaptan for the episode of hyponatraemia being captured in the study from the patient's medical records

  7. Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study

    Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards

    Average daily dose of tolvaptan used and treatment duration (expressed in days) for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment).

    For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered).

  8. Time (Days) to Sodium Normalisation

    Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards

    Time (days) to sodium normalisation, defined as a serum sodium level > 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation).

  9. Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia

    Time frame: Baseline

    symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records

  10. Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study

    Time frame: From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards

    Average treatment duration for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment).

    For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered).

Other outcomes

  1. Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)

    Time frame: From baseline (tolvaptan treatment initiation) up to 6 weeks after treatment initiation

    Only medications taken by more than 5% of the study population are presented

  2. Prior Treatments Before Tolvaptan (Number and Percentage of Subjects Taking Prior Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)

    Time frame: From 12 months up to baseline (tolvaptan treatment initiation)

    Only medications taken by more than 5% of the study population are presented

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Europe Ltd

Industry

Registry information

Official study title

A Non Interventional, Retrospective Study on Real World Usage and Treatment Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to the SIADH.

Acronym: SAMPLE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2015
Registry last updated
Mar 7, 2018

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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