A DOUBLE-BLIND, RANDOMIZED, PLACEBO-AND ACTIVE-CONTROLLED EFFICACY AND SAFETY STUDY OF THE EFFECTS OF BAZEDOXIFENE/CONJUGATED ESTROGENS COMBINATIONS ON ENDOMETRIAL HYPERPLASIA AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN Primary Safety Objective: To confirm the endometrial safety of BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg based on an endometrial hyperplasia incidence of less than 1% at year 1. Primary Efficacy...

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A Randomized, Open-Label Study to Compare the Safety and Efficacy of Conversion From a Calcineurin Inhibitor to Sirolimus Versus Continued Use of a Calcineurin Inhibitor in Cardiac Transplant Recipients With Mild to Moderate Renal Insufficiency To demonstrate the superiority of converting from CNI therapy to sirolimus therapy to continuing CNI therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal...

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A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREATMENT-WITHDRAWAL STUDY OF THE EFFICACY AND SAFETY OF PANTOPRAZOLE SODIUM ENTERIC-COATED GRANULES IN INFANTS (1 THROUGH 11 MONTHS) WITH SYMPTOMATIC GERD To assess the efficacy of treatment with pantoprazole granules administered as a suspension in pediatric patients 1 through 11 months of age. The difference in withdrawal rates will compared between t...

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A Phase 3, Randomized, Active-Controlled, Double-Blind, Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Spain. - Estudio fase III, randomizado, controlado, doble ciego para evaluar la seguridad, tolerabilidad e inmunogenicidad de la Vacuna Neumocócica Conjugada 13-valente en niños sanos administrada según calendario vacunal en España Primary objectives· - To demonstrate that the immune response induced by Meningitec given with 13vPnC is noninferior to the immune response induced by Meningitec given with 7vPnC when measured 1 month...

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A Phase 3, Randomized, Open-Label, Two-Arm Study of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel as First-Line Treatment for ErbB-2-Positive Locally Recurrent or Metastatic Breast Cancer - To compare the independently assessed progression-free survival following treatment with neratinib in combination with paclitaxel versus trastuzumab plus paclitaxel in subjects who have not received...

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A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103 Administered to Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate To evaluate the safety and clinical efficacy of multiple ascending doses (MAD) of ATN-103 administered SC to subjects with active RA compared with placebo.

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A Double-Blind, Placebo-Controlled, Parallel, Randomized Study To Evaluate The Efficacy And Safety Of 3 Oral Dose Levels Of TMI-005 In Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate To compare the efficacy and the safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active RA who have been receiving stable doses of MTX.

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A Double-Blind, Placebo-Controlled, Randomized, Single-Dose, 2-Period Crossover Study of the Pharmacodynamics of Orally Administered PSI-697 in Healthy Subjects Who Smoke To assess the pharmacodynamics (PD) of a single oral dose of PSI-697 in healthy subjects who smoke.

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A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, LONG-TERM EXTENSION STUDY TO DETERMINE THE SAFETY, TOLERABILITY, AND PRELIMINARY LONG TERM EFFICACY OF LECOZOTAN SRA-333 SR IN PATIENTS WITH MILD TO MODERATE ALZHEIMER S DISEASE TREATED WITH A CHOLINESTERASE INHIBITOR To evaluate the safety and tolerability of long-term therapy with three total daily dose levels of lecozotan SR 2, 5, 10 mg administered to patients with mild to moderate Alzheimer s Disease who hav...

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A Phase 1/2 Study of SKI-606 in Philadelphia Chromosme Positive Leukemias Part 1 (Dose-escalation part): Part 1 of study is Completed - Define the maximum tolerated dose, less than or equal to 1000 mg/day, in subjects with CML in chronic phase resistant or refractory to ima...

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