Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Mar 2023

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Tolvaptan (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Registrational; Therapeutic Use
  • Acronyms TEMPO3:4
  • Sponsors Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 01 Mar 2023 Results assessing the clinical pattern and hepatic safety profile of tolvaptan in patients with autosomal dominant polycystic kidney disease from NCT00428948 (TEMPO 3:4), NCT01214421 (TEMPO 4:4), NCT02160145 (REPRISE), and NCT02251275 (long-term extension) studies, published in the American Journal of Kidney Diseases.
    • 24 Apr 2018 According to an Otsuka Pharmaceutical media release, the US FDA has approved tolvaptan (JYNARQUE) as the first drug treatment to slow kidney function decline in adults at risk rapidly progressing autosomal dominant polycystic kidney diesase (ADPKD). The regulatory application included data from this trial.
    • 01 May 2017 Results of determinants of urine osmolality published in the Journal of the American Society of Nephrology
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top