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

NCT00728091 | Terminated Phase 3 DMC

• 2 other identifiers: EFC10102EudraCT:2007-007941-10
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyponatremia; Inappropriate ADH Syndrome

Keywords

aquaretic; SIADH

Outcome Measures

Primary Outcomes (1)

• serum sodium change from baseline

  At Day 5 pre-dose

Secondary Outcomes (3)

• responder rate

  At Day 5 pre-dose

• presence and intensity of clinical symptoms related to hyponatremia

  At each scheduled visit

• change from baseline in cognitive function

  At Day 5 and 30

Study Arms (3)

Satavaptan Dose 1

EXPERIMENTAL

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

Drug: Satavaptan

Satavaptan Dose 2

EXPERIMENTAL

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

Drug: Satavaptan

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Satavaptan DRUG

tablets

Also known as: SR121463

Satavaptan Dose 1; Satavaptan Dose 2

placebo DRUG

tablets

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Hyponatremia; Inappropriate ADH Syndrome

Interventions

satavaptan

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 5, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 26, 2016

Record last verified: 2016-04

Locations

US (1)