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NCT ID: NCT01209689 Terminated - Clinical trials for Spondylitis, Ankylosing

A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy

Start date: October 2010
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv) or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all patients. This study and all further clinical development of tocilizumab AS was halted after a review of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in TNF antagonist naïve AS patients, failed to demonstrate efficacy.

NCT ID: NCT01208285 Completed - Clinical trials for In Development for Cystic Fibrosis

Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects

Start date: September 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the pharmacokinetics and safety of a single dose of VX-770 in subjects with moderate hepatic impairment.

NCT ID: NCT01208233 Terminated - Ischemic Stroke Clinical Trials

Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke

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

The purpose of this study is to evaluate the safety and tolerability of PF-03049423 following multiple dose administration to subjects with ischemic stroke. The study will also evaluate the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke following 90 days of therapy. The study will also explore the relationship between PF-03049423 concentration and blood pressure.

NCT ID: NCT01208194 Completed - Clinical trials for Advanced Colorectal Carcinoma

Efficacy Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma

IMPACT
Start date: June 2010
Phase: Phase 2
Study type: Interventional

This is a phase 2, randomized, double-blind, multi-center clinical study to evaluate efficacy and safety of a maintenance therapy with the immunomodulator MGN1703 compared to placebo control. The study will be conducted in patients with advanced colorectal carcinoma (AJCC Stage IV) with disease control after first-line standard chemotherapy regimens.

NCT ID: NCT01204749 Completed - Ovarian Cancer Clinical Trials

TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

NCT ID: NCT01203605 Completed - Non-cardiac Surgery Clinical Trials

European Surgical Outcomes Study

EuSOS
Start date: April 2011
Phase: N/A
Study type: Observational

The European Surgical Outcomes Study (EuSOS) is a multi-centre, international cohort study of peri-operative care and clinical outcomes for patients undergoing non-cardiac surgery. Participating centres throughout Europe will contribute routine clinical data describing all eligible patients who undergo surgery from 4th April 2011 to 11th April 2011. Patients will then be followed until hospital discharge (or for a maximum of 60 days) for duration of hospital stay and hospital mortality. Routine clinical data will also be collected for those patients admitted to critical care at any stage after surgery but during the same hospital admission. Specific objectives are to describe clinical outcomes and standards of peri-operative care for patients undergoing non-cardiac surgery in Europe.

NCT ID: NCT01202591 Completed - ER+ Breast Cancer Clinical Trials

Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

GLOW
Start date: December 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)

NCT ID: NCT01202565 Completed - Clinical trials for Moderate to Severe Plaque Psoriasis

Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice

Start date: September 2010
Phase: N/A
Study type: Observational

There is clearly a need for further data on the efficacy of biologic agents in the treatment of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports can be found, but no published data exists from non-interventional studies, such as post-marketing observational studies (PMOS) that reflect routine clinical practice. The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the treatment of nail and scalp psoriatic lesions in routine dermatologic practice.

NCT ID: NCT01200186 Completed - Clinical trials for Contraceptives, Oral

Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction

Start date: October 2010
Phase: Phase 4
Study type: Observational

Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.

NCT ID: NCT01199081 Completed - Atrial Fibrillation Clinical Trials

Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation

ARTEMIS AF LT
Start date: October 2010
Phase: Phase 4
Study type: Interventional

Primary Objective: - Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation. Secondary Objective: - Explore potential PK interaction between Dronedarone and Amiodarone - Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from randomization up to 60 days after) - To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety