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Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT00428948 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1445

Last updated 2017-07-02

Study results available
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Summary

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

Conditions

  • Polycystic Kidney Disease, Autosomal Dominant

Interventions

DRUG

Tolvaptan

Tolvaptan was supplied as tablets.

DRUG

Placebo

Placebo was supplied as tablets.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Vicente Torres, MD, PhD · Mayo Medical Center

  • Frank Czerwiec, MD, PhD · Otsuka Pharmaceutical Development and Commercialization, Inc.

  • Osamu Sato · Otsuka Pharmaceutical Corporation, Ltd. Japan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Romania
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00428948 on ClinicalTrials.gov