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
Phase 3
Completed
- Conditions
- Genetic disease whereby the kidneys contain mutiple cysts filled with fluid1003836010038430
- Registration Number
- NL-OMON30613
- Lead Sponsor
- Otsuka America Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
*GFR estimated at >= 60mL/min
*Expected rapidly progressive kidney growth (total volume >=750cc) by Magnetic Resonance Imaging (MRI) at randomization
Exclusion Criteria
* Safety contraindications including: non-compliance with therapies, insufficient or no reproductive precautions, unawareness of thirst, severe allergic reactions to compounds with similar chemical structure
* Contraindications to or interference with MRI assessments
* Concurrent conditions or taking therapies likely to confound endpoint assessments or prevent completion of the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Rate of renal volume (total, both kidneys) change (normalized as percentage)<br /><br>for tolvaptan (combining all doses) relative to placebo </p><br>
- Secondary Outcome Measures
Name Time Method