Tolvaptan Phase 3 Efficacy and Safety Study in ADPKD — TEMPO3/4  

Polycystic Kidney Disease, Autosomal Dominant Clinical Trial

Official title: A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease

Status Completed

Clinical Trial Summary

This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.

Clinical Trial Description

The current study will evaluate whether tolvaptan will be potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total renal volume increase, while impacting the onset, severity and progression of other important consequences of ADPKD. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Polycystic Kidney Disease, Autosomal Dominant
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

• NCT number: NCT00428948
• Study type: Interventional
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: January 2007
• Completion date: January 2012