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NCT00456365 · ClinicalTrials.gov registry record · Phase 3
Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
A Phase 3 study of Polycystic Kidney, Autosomal Dominant, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 3
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT00456365: Completed Phase 3 study of Polycystic Kidney, Autosomal Dominant, sponsored by University of Colorado, Denver.
NCT00456365 is a Phase 3 study of Polycystic Kidney, Autosomal Dominant that has completed, run by University of Colorado, Denver. The registered enrollment target is 110 participants, above the 50-participant average among 4 other Polycystic Kidney, Autosomal Dominant trials with a reported enrollment target (120% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00456365, a Phase 3 study of Polycystic Kidney, Autosomal Dominant, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether the medication pravastatin will ameliorate renal and cardiovascular disease over a 3-year period in children and young adults with autosomal dominant polycystic kidney disease (ADPKD).
Primary Outcome
Percent of participants demonstrating 20% or more increase in total kidney volume corrected for height, left ventricular mass index, or urinary albumin excretion over the three year study period
Conditions Studied
Interventions
- DRUG Placebo
- DRUG pravastatin
Study Locations (1)
Colorado
- University of Colorado at Denver and Health Sciences Center - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2006-11 |
| Est. Completion | 2012-10 |
| Phase | Phase 3 |
What the finished NCT00456365 record still lists
NCT00456365 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, above the 50-participant average among 4 other Polycystic Kidney, Autosomal Dominant trials with a reported enrollment target (120% higher).
The record links to 1 condition, with Polycystic Kidney, Autosomal Dominant appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00456365 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT00456365 about?
NCT00456365 is a clinical study titled "Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)". The purpose of this study is to determine whether the medication pravastatin will ameliorate renal and cardiovascular disease over a 3-year period in children and young adults with autosomal dominant polycystic kidney disease (ADPKD).
What is the current status of trial NCT00456365?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2006-11. Estimated completion is 2012-10.
What conditions does trial NCT00456365 study?
This clinical trial studies the following conditions: Polycystic Kidney, Autosomal Dominant.
What interventions are being tested in trial NCT00456365?
The interventions under investigation include: Placebo (DRUG), pravastatin (DRUG).
Who is sponsoring clinical trial NCT00456365?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00456365 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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