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Clinical Trials/NL-OMON30613
NL-OMON30613
Completed
Phase 3

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 - Fase III trial in adult subjects with ADPKD

Otsuka America Pharmaceutical0 sites70 target enrollmentTBD
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Conditions10038430Genetic disease whereby the kidneys contain mutiple cysts filled with fluid10038360

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
10038430
Sponsor
Otsuka America Pharmaceutical
Enrollment
70
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
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 DiseaseAutosomal Dominant Polycystic Kidney Disease (ADPKD)MedDRA version: 8.1 Level: LLT Classification code 10036046 Term: Polycystic kidney, autosomal dominant
EUCTR2006-002768-24-GBOtsuka Pharmaceutical Development & Commercialization, Inc.1,500
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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 DiseaseAutosomal Dominant Polycystic Kidney Disease (ADPKD)MedDRA version: 8.1Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominant
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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 -Autosomal Dominant Polycystic Kidney Disease (ADPKD)MedDRA version: 8.1Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominant
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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
EUCTR2006-002768-24-FROtsuka Maryland Research Institute, Inc.1,500
Active, not recruiting
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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 DiseaseAutosomal Dominant Polycystic Kidney Disease (ADPKD)MedDRA version: 8.1Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominant
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