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NCT00732615 · ClinicalTrials.gov registry record · Phase 3
Use of NPSP558 in the Treatment of Hypoparathyroidism
A Phase 3 study of Hypoparathyroidism, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 124
- Enrollment target
- 20
- Study locations
NCT00732615: Completed Phase 3 study of Hypoparathyroidism, sponsored by Shire.
NCT00732615 is a Phase 3 study of Hypoparathyroidism that has completed, run by Shire. The registered enrollment target is 124 participants, below the 187-participant average among 10 other Hypoparathyroidism trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00732615, a Phase 3 study of Hypoparathyroidism, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 124 participants
- Enrollment target
- 20
- Study locations
Study Summary
Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.
Primary Outcome
The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NPSP558
Study Locations (20)
California
- Advance Medical Research LLC - Lakewood
- Diabetes Associates - Orange
- University of California-San Francisco VA Medical Center - San Francisco
Florida
- Palm Springs Research Institute - Hialeah
- Mayo Clinic Jacksonville - Jacksonville
New York
- Columbia University Medical Center - New York
- University Physicians Group - Staten Island
Texas
- Cetero Research DGD Research Inc. - San Antonio
- Hillcrest Family Health Center - Waco
Arizona
- Mayo Clinic-Scottsdale - Scottsdale
Illinois
- University of Chicago Medical Center - Chicago
Indiana
- Indiana University School of Medicine - Indianapolis
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2008-12-18 |
| Est. Completion | 2011-09-28 |
| Phase | Phase 3 |
What the finished NCT00732615 record still lists
NCT00732615 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 187-participant average among 10 other Hypoparathyroidism trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Hypoparathyroidism appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00732615 names 20 study sites across 15 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT00732615 about?
NCT00732615 is a clinical study titled "Use of NPSP558 in the Treatment of Hypoparathyroidism". Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.
What is the current status of trial NCT00732615?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 124 participants. The study started on 2008-12-18. Estimated completion is 2011-09-28.
What conditions does trial NCT00732615 study?
This clinical trial studies the following conditions: Hypoparathyroidism.
What interventions are being tested in trial NCT00732615?
The interventions under investigation include: Placebo (DRUG), NPSP558 (DRUG).
Who is sponsoring clinical trial NCT00732615?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00732615 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypoparathyroidism
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Where NCT00732615's enrollment target sits among peer trials
124 2nd of 10 the highest of 10 other Hypoparathyroidism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypoparathyroidism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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