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NCT00541658 · ClinicalTrials.gov registry record · Phase 3
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
A Phase 3 study of Postmenopausal Osteoporosis, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 3
- Development phase
- 923
- Enrollment target
- 20
- Study locations
NCT00541658: Completed Phase 3 study of Postmenopausal Osteoporosis, sponsored by Warner Chilcott.
NCT00541658 is a Phase 3 study of Postmenopausal Osteoporosis that has completed, run by Warner Chilcott. The registered enrollment target is 923 participants, above the 455-participant average among 14 other Postmenopausal Osteoporosis trials with a reported enrollment target (103% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00541658, a Phase 3 study of Postmenopausal Osteoporosis, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 923 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
Conditions Studied
Interventions
- DRUG risedronate
Study Locations (20)
California
- Research Site - Oakland
- Research Site - San Diego
- Research Facility - Walnut Creek
- Research Site - Walnut Creek
Florida
- Research Site - Leesburg
- Research Site - Melbourne
- Research Site - South Miami
Illinois
- Research Site - Champaign
- Research Site - Chicago
Alabama
- Research Site - Birmingham
Colorado
- Research Site - Lakewood
Georgia
- Research Site - Gainesville
Maryland
- Research Site - Bethesda
Massachusetts
- Research Site - Brockton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 923 participants |
| Start Date | 2007-10 |
| Est. Completion | 2010-04 |
| Phase | Phase 3 |
What the finished NCT00541658 record still lists
NCT00541658 is an interventional study that assigns participants to a tested intervention. The registered 923 participants enrollment target is mid-sized for trials with a published cap, above the 455-participant average among 14 other Postmenopausal Osteoporosis trials with a reported enrollment target (103% higher).
The record links to 1 condition, with Postmenopausal Osteoporosis appearing as the primary indexed condition, and to 1 intervention - of which risedronate is the first listed.
NCT00541658 names 20 study sites across 14 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00541658 about?
NCT00541658 is a clinical study titled "A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis". The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
What is the current status of trial NCT00541658?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 923 participants. The study started on 2007-10. Estimated completion is 2010-04.
What conditions does trial NCT00541658 study?
This clinical trial studies the following conditions: Postmenopausal Osteoporosis.
What interventions are being tested in trial NCT00541658?
The interventions under investigation include: risedronate (DRUG).
Who is sponsoring clinical trial NCT00541658?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00541658 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postmenopausal Osteoporosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00541658's enrollment target sits among peer trials
923 3rd of 14 higher than 12 of 14 other Postmenopausal Osteoporosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postmenopausal Osteoporosis 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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