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

Hyponatremia Clinical Trial

— SAMPLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545101
• Other study ID #: 156-303-00034
• Status: Completed
• Phase: N/A
• First received: September 7, 2015
• Last updated: February 5, 2018
• Start date: November 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2018
• Source: Otsuka Pharmaceutical Europe Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyponatremia
• Inappropriate ADH Syndrome
• Syndrome of Inappropriate ADH (SIADH) Secretion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Europe Ltd

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)	Only medications taken by more than 5% of the study population are presented	From baseline (tolvaptan treatment initiation) up to 6 weeks after treatment initiation
Other	Prior Treatments Before Tolvaptan (Number and Percentage of Subjects Taking Prior Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)	Only medications taken by more than 5% of the study population are presented	From 12 months up to baseline (tolvaptan treatment initiation)
Primary	Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge	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).	From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment)
Secondary	Change in Sodium Levels 24 Hours After Treatment Initiation	Change in sodium level from last value prior to receiving tolvaptan until last available measurement within 24 hours of initiation of tolvaptan	From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards
Secondary	Change in Sodium Levels 6 Weeks After Treatment Initiation	Change in sodium level from last value prior to receiving tolvaptan until last available measurement up to week 6	From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Secondary	Time (Hours) to Sodium Normalisation	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).	From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Secondary	Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,)	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	Baseline
Secondary	Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population)	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	Baseline
Secondary	Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,)	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	Baseline
Secondary	Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study	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).	From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Secondary	Time (Days) to Sodium Normalisation	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).	From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards
Secondary	Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia	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	Baseline
Secondary	Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study	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).	From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards