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NCT ID: NCT01352793 Completed - Clinical trials for Meningitis, Meningococcal

A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

Start date: November 2012
Phase: Phase 3
Study type: Interventional

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2. All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

NCT ID: NCT01350804 Completed - Clinical trials for Rheumatoid Arthritis

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 1 Year of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents.

NURTURE 1
Start date: September 2011
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.

NCT ID: NCT01345799 Completed - Crohn's Disease Clinical Trials

A Study of TRK-170 for the Treatment of Crohn's Disease

Start date: April 2011
Phase: Phase 2
Study type: Interventional

In Crohn's Disease Patients - To evaluate the efficacy of TRK-170 - To evaluate the PK characteristics of TRK-170 - To assess the safety of TRK-170

NCT ID: NCT01345045 Completed - Clinical trials for Diabetic Neuropathic Pain

A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain

Start date: April 2011
Phase: Phase 2
Study type: Interventional

People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.

NCT ID: NCT01344460 Completed - Clinical trials for Renal Artery Obstruction

Gadobutrol Enhanced MRA of the Renal Arteries

GRAMS
Start date: May 2011
Phase: Phase 3
Study type: Interventional

Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required. This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study. MRA and CTA images will be collected for an independent review (blinded read).

NCT ID: NCT01343004 Completed - Osteoporosis Clinical Trials

Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women

ACTIVE
Start date: April 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether BA058 (abaloparatide), a parathyroid hormone-related peptide, is effective in preventing fractures in postmenopausal women with severe osteoporosis who are at risk of fractures.

NCT ID: NCT01341613 Completed - Clinical trials for Hypercholesterolemia

Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation

Start date: May 2011
Phase: Phase 2
Study type: Interventional

Background: It is becoming increasingly clear that individuals from all corners of the globe use probiotic dietary approaches to enhance health. More recently, probiotics have shown promise in treating a variety of disease states, due to improved strain selection, stability and delivery technologies. Objective: The purpose of this study is to determine the lipid lowering efficacy of a probiotic supplement capsule containing Lactobacillus reuteri Cardioviva™, taken twice per day over 9 weeks, in subjects with hypercholesterolemia. Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm, multi-centre study. The study will last a total of 13 weeks, including a 2-week wash-out period, a 2-week run-in period and a 9 week treatment period.

NCT ID: NCT01340664 Completed - Clinical trials for Diabetes Mellitus, Type 2

An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy

Start date: July 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.

NCT ID: NCT01336465 Completed - Ulcerative Colitis Clinical Trials

Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

Start date: September 2011
Phase: Phase 2
Study type: Interventional

This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.

NCT ID: NCT01335464 Completed - Pulmonary Fibrosis Clinical Trials

Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients

Start date: April 2011
Phase: Phase 3
Study type: Interventional

Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate. In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo. Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data. Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.