MedTrace Logo

8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT01451827 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2018-09-27

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.

Conditions

  • Autosomal Dominant Polycystic Kidney Disease

Interventions

DRUG

Tolvaptan MR

50/80 mg capsules

DRUG

Tolvaptan IR

60/30 mg capsules

DRUG

Placebo

tablet

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Frank Czerwiec, M.D., Ph.D. · Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

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 NCT01451827 on ClinicalTrials.gov