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NCT ID: NCT00946920 Completed - Prostate Cancer Clinical Trials

A Trial of Degarelix in Patients With Prostate Cancer

Start date: June 2009
Phase: Phase 3
Study type: Interventional

A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.

NCT ID: NCT00944034 Completed - Clinical trials for Meningococcal Disease

Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12

Start date: July 2009
Phase: Phase 2/Phase 3
Study type: Interventional

This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two different three-dose immunization schedules in infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following the two different immunization schedules, in order to identify the optimal timing for boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12 (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort of subjects enrolled). These subjects will generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls for a descriptive comparison of antibody persistence and booster responses for the other groups.

NCT ID: NCT00941798 Completed - Asthma Clinical Trials

Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma

Start date: July 2009
Phase: Phase 2
Study type: Interventional

Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.

NCT ID: NCT00941707 Terminated - Clinical trials for Rheumatoid Arthritis

An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis

Start date: February 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, tolerability and safety of JNJ-38518168 compared with placebo in adult participants with active rheumatoid arthritis (long time systemic disease of the joints, marked by inflammatory changes in the synovial membranes and bones) despite methotrexate (MTX) therapy.

NCT ID: NCT00939003 Completed - Clinical trials for Axial Spondyloarthritis

Study of Adalimumab in Patients With Axial Spondyloarthritis

Start date: July 2009
Phase: Phase 3
Study type: Interventional

This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.

NCT ID: NCT00938730 Completed - Atrial Fibrillation Clinical Trials

A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation

OPAL-2
Start date: June 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data.

NCT ID: NCT00937521 Completed - Clinical trials for Meningococcal Meningitis

Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants

Start date: July 2009
Phase: Phase 2
Study type: Interventional

This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.

NCT ID: NCT00936403 Completed - Clinical trials for Growth Hormone Disorder

A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone

Start date: August 2009
Phase: Phase 2
Study type: Interventional

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in growth hormone deficient children.

NCT ID: NCT00936221 Completed - Melanoma Clinical Trials

Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients

Start date: July 2009
Phase: Phase 2
Study type: Interventional

To assess the efficacy in terms of overall survival of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

NCT ID: NCT00930553 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

Start date: August 2009
Phase: Phase 3
Study type: Interventional

This open-label, rater-blinded extension study will enroll patients who have relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab [CAMMS223 (NCT00050778), CAMMS323 (NCT00530348) also known as CARE-MS I, or CAMMS324 (NCT00548405) also known as CARE-MS II]. The purposes of this study are: 1. To examine the long term safety and efficacy of alemtuzumab treatment in patients who received alemtuzumab as their study treatment in one of the prior studies. 2. To examine the safety and efficacy of initial alemtuzumab treatment in this study for patients who received Rebif® (interferon beta-1a) as their study treatment in one of the prior studies. 3. To determine if and when further alemtuzumab treatment is needed, and the safety and efficacy of this "as needed" treatment. This applies both to patients who received alemtuzumab for the first time in one of the prior studies or for the first time in this extension study.