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NCT00577837 · ClinicalTrials.gov registry record · Phase 2
Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD
A Phase 2 study of Postmenopausal, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 2
- Development phase
- 370
- Enrollment target
- 14
- Study locations
NCT00577837 is a Phase 2 study of Postmenopausal that has completed, run by Warner Chilcott. The registered enrollment target is 370 participants, above the 100-participant average among 9 other Postmenopausal trials with a reported enrollment target (270% higher). The trial reports 14 study locations across 6 states.
The verdict
NCT00577837, a Phase 2 study of Postmenopausal, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 370 participants
- Enrollment target
- 14
- Study locations
Study Summary
A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.
Conditions Studied
Interventions
- DRUG risedronate
- DRUG experimental
Study Locations (14)
Other
- Research Facility - Zagreb
- Research Facility - Amsterdam
- Research Facility - Leiden
- Research Facility - Bialystok
- Research Site - Lublin
- Research Site - Warsaw
- Research Site - Wroclaw
Florida
- Research Site - Daytona Beach
- Research Site - Gainesville
Quebec
- Research Facility - Montreal
- Research Facility - Sainte-Foy
Kansas
- Research Site - Shawnee Mission
Texas
- Research Site - San Antonio
Ontario
- Research Site - Hamilton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2004-04 |
| Est. Completion | 2005-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00577837
The ClinicalTrials.gov registry entry for NCT00577837 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 100-participant average among 9 other Postmenopausal trials with a reported enrollment target (270% higher). The listed sponsor is Warner Chilcott, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Postmenopausal appearing as the primary indexed condition, and to 2 interventions - of which risedronate is the first listed.
NCT00577837 reports 14 study locations spanning 6 distinct geographic areas - top geographies include Other, Florida, Quebec.
Frequently Asked Questions
What is clinical trial NCT00577837 about?
NCT00577837 is a clinical study titled "Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD". A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.
What is the current status of trial NCT00577837?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 370 participants. The study started on 2004-04. Estimated completion is 2005-06.
What conditions does trial NCT00577837 study?
This clinical trial studies the following conditions: Postmenopausal.
What interventions are being tested in trial NCT00577837?
The interventions under investigation include: risedronate (DRUG), experimental (DRUG).
Who is sponsoring clinical trial NCT00577837?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00577837 being conducted?
This trial has 14 study locations across Florida, Kansas, Texas, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.