Phase 3 Clinical Program Sample Clauses
The 'Phase 3 Clinical Program' clause defines the requirements and scope for conducting advanced-stage clinical trials, typically aimed at confirming the efficacy and safety of a drug or treatment in a large patient population. This clause outlines the necessary protocols, endpoints, and regulatory standards that must be met during these trials, and may specify responsibilities for data collection, reporting, and compliance with applicable laws. Its core function is to ensure that both parties understand the expectations and obligations for this critical stage of drug development, thereby facilitating regulatory approval and minimizing misunderstandings or delays.
Phase 3 Clinical Program. The Phase 3 study will be a non-inferiority trial versus Forteo® to be conducted in postmenopausal women with osteoporosis at risk of fracture. The Phase 3 study will be a randomized, double-blind study with a primary endpoint of proportion of patients with one or more new vertebral fractures. The tentative plan for this study is to assess a more convenient dosing regimen of BA058 (e.g. 4-6 months of daily SC injections) versus a 12-month treatment regimen with Forteo®. After completion of the study, an observational post-treatment follow up study will be conducted to assess whether patients continue to benefit from prior treatment with study medication. Title: Effects of BA058 in the Treatment of Postmenopausal Women with Osteoporosis Protocol Number: BA058-05-003 Title: Extended Follow-Up of Patients in BA058 Clinical Trials Protocol Number: BA058-05-004 The primary objective of the study is to: · Demonstrate a reduction in the proportion of patients with new vertebral fractures following treatment with study medication. The secondary objectives of the study are to: · Establish the safety of chronic administration of BA058 in postmenopausal women with osteoporosis. · Compare the effects of chronic administration of BA058 with calcium and vitamin D versus Forteo® with calcium and vitamin D on lumbar spine and hip BMD in postmenopausal women with osteoporosis. · Assess the effects of chronic administration of BA058 on biochemical markers of bone formation and resorption. · Assess the durability of response by following patients in a long-term post-study observational period. A total of 3200 eligible patients will be enrolled and randomized to one of the two treatments below: *Assumes a ratio of BA058: Forteo of 1:1.
Phase 3 Clinical Program. The Phase 3 study is designed to provide evidence of long-term endometrial safety of ER-306323. In addition, the Phase 3 study will provide additional confirmation of efficacy of ER-306323 for reduction in frequency and severity of hot flashes in women with moderate and severe postmenopausal vasomotor symptoms. The Phase 3 trial will be a statistically-powered, double-blind, randomized, multicenter trial that will be powered on the basis of the reduction of hot flashes but which will enroll a sufficient number of women to provide adequate assessment of endometrial safety over 12 months. It is generally requested that more than one dose of the new medication be studied in the Phase 3 safety trial. As a study of endometrial safety, the Phase 3 trial will only enroll women with an intact uterus and, as a safety measure, will exclude women with any history of breast cancer or of a recent abnormal mammogram. This study will also provide further evidence of the efficacy of ER-306323 on BMI), while not in the traditional population of women with documented severe osteoporosis.
Phase 3 Clinical Program. The Phase 3 study will be a non-inferiority trial versus Forteo® to be conducted in postmenopausal women with osteoporosis at risk of fracture.
Phase 3 Clinical Program. The Phase 3 study is designed to provide evidence of long-term endometrial safety of ER-306323. In addition, the Phase 3 study will provide additional confirmation of efficacy of ER-306323 for reduction in frequency and severity of hot flashes in women with moderate and severe postmenopausal vasomotor symptoms. * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission. The Phase 3 trial will be a statistically-powered, double-blind, randomized, multicenter trial that will be powered on the basis of the reduction of hot flashes but which will enroll a sufficient number of women to provide adequate assessment of endometrial safety over 12 months. It is generally requested that more than one dose of the new medication be studied in the Phase 3 safety trial. As a study of endometrial safety, the Phase 3 trial will only enroll women with an intact uterus and, as a safety measure, will exclude women with any history of breast cancer or of a recent abnormal mammogram. This study will also provide further evidence of the efficacy of ER-306323 on BMI), while not in the traditional population of women with documented severe osteoporosis.