A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to assess the efficacy of satavaptan versus placebo in participants with dilutional hyponatremia due to SIADH.

Secondary objectives are to assess the safety of satavaptan, the maintenance of effect, and the clinical benefit in these participants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

NCT00032734

Syndrome of Inappropriate ADH (SIADH) Secretion Hyponatremia

COMPLETED PHASE2

Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

NCT00264927

Inappropriate ADH Syndrome Hyponatremia

COMPLETED PHASE3

Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

NCT00264914

Inappropriate ADH Syndrome Hyponatremia

COMPLETED PHASE3

Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)

NCT00843986

Hyponatremia Acute Decompensated Heart Failure

TERMINATED PHASE3

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia

NCT00660959

Hyponatremia With Normal Extracellular Fluid Volume

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyponatremia Inappropriate ADH Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Satavaptan Dose 1

Fixed Low dose up to day 4, followed by optional titration up to day 30

Group Type EXPERIMENTAL

Satavaptan

Intervention Type DRUG

tablets

Satavaptan Dose 2

Fixed High dose up to day 4, followed by optional titration up to day 30

Group Type EXPERIMENTAL

Satavaptan

Intervention Type DRUG

tablets

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Satavaptan

tablets

Intervention Type DRUG

placebo

tablets

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SR121463

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants with symptomatic syndrome of inappropriate antidiuretic hormone secretion (SIADH) with chronic hyponatremia

Exclusion Criteria

* Presence of clinical signs of hypovolemia (e.g. orthostatic decreases in blood pressure and increase in pulse rate, dry mucus membranes, decreased skin turgor)
* Presence of clinical signs of hypervolemia (e.g. generalized edema, jugular venous extension)
* Participants with adrenocortical insufficiency
* Participants with hypothyroidism
* Participants with known causes of transient SIADH
* Participants with psychogenic polydipsia or beer potomania
* Concomitant use of thiazide diuretics during the study
* Presence of uncontrolled diabetes with fasting blood glucose ≥200 mg/dL (≥11.09 mmol/L) at time of screening
* Participants with impaired hepatic function or liver cirrhosis (Child-Pugh A-C)
* Pregnant or breast-feeding women

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No