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A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia (AQUARIST1)

This study has been terminated.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00728091
First received: July 31, 2008
Last updated: March 16, 2009
Last verified: March 2009
History of Changes
  Purpose

The primary objective of this study is to assess the efficacy of satavaptan versus placebo in patients 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 patients.


Condition Intervention Phase
Hyponatremia
Inappropriate ADH Syndrome
 Drug: satavaptan (SR121463)
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of Two Doses of Satavaptan (SR121463B) Versus Placebo in Patients With Dilutional Hyponatremia Due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • serum sodium change from baseline [ Time Frame: At Day 5 pre-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • responder rate [ Time Frame: At Day 5 pre-dose ] [ Designated as safety issue: No ]
  • presence and intensity of clinical symptoms related to hyponatremia [ Time Frame: At each scheduled visit ] [ Designated as safety issue: No ]
  • change from baseline in cognitive function [ Time Frame: At Day 5 and 30 ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: July 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fixed Low dose up to day 4, followed by optional titration up to day 30
 Drug: satavaptan (SR121463)
tablets
Experimental: 2
Fixed High dose up to day 4, followed by optional titration up to day 30
 Drug: satavaptan (SR121463)
tablets
Placebo Comparator: 3 Drug: placebo
tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 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)
  • Patients with adrenocortical insufficiency
  • Patients with hypothyroidism
  • Patients with known causes of transient SIADH
  • Patients 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
  • Patients 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 patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728091

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00728091     History of Changes
Other Study ID Numbers: EFC10102, EudraCT:2007-007941-10
Study First Received: July 31, 2008
Last Updated: March 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
aquaretic
SIADH

Additional relevant MeSH terms:
Hyponatremia
Inappropriate ADH Syndrome
Water-Electrolyte Imbalance
Metabolic Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Vasopressins
 Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013