A PK Study of 3 Dosages of Tolvaptan in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) Clinical Trial

Official title: A Phase 1b, Multicenter, Pilot, Randomized, Double-blind Trial to Determine the Pharmacokinetics and Pharmacodynamics of Orally Administered Tolvaptan 3.75, 7.5, and 15 mg Tablets in Subjects With Syndrome of Inappropriate Antidiuretic Hormone Secretion

Status Completed

Clinical Trial Summary

This is a study to evaluate how the body handles and metabolizes (PK) the various doses of the drug Tolvaptan, and what the effect (PD) of the various doses of Tolvaptan are on the content of "salt" in blood and urine

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Insipidus
• Inappropriate ADH Syndrome
• Syndrome
• Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

• NCT number: NCT02009878
• Study type: Interventional
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 2013
• Completion date: June 2015