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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00481169 |
The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an investigational drug, is safe and effective in the prevention of osteoporosis in postmenopausal women.
Condition | Intervention | Phase |
---|---|---|
Osteoporosis |
Drug: Bazedoxifene Acetate (TSE-424) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double Blind, Randomized, Placebo and Raloxifene Controlled Study to Assess Safety and Efficacy of TSE-424 (Bazedoxifene Acetate) in the Prevention of Postmenopausal Osteoporosis |
Estimated Enrollment: | 1735 |
Study Start Date: | July 2001 |
Primary objective: To evaluate the safety and efficacy of 3 doses of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with those of placebo and raloxifene in preventing osteoporosis in postmenopausal women.
Secondary objective: To evaluate the effect of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with that of placebo and raloxifene on endometrium, metabolic parameters, vasomotor symptoms, adverse events, and quality of life. Samples will be collected for population pharmacokinetic (PK) analysis.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 3068A1-300 |
Study First Received: | May 30, 2007 |
Last Updated: | May 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00481169 |
Health Authority: | United States: Food and Drug Administration |
Postmenopausal Osteoporosis |
Raloxifene Musculoskeletal Diseases Osteoporosis, Postmenopausal |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |