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NCT ID: NCT01361126 Completed - Hemophilia B Clinical Trials

A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B

Start date: July 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This study will examine the safety and efficacy of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B. The study consists of a screening period, a pharmacokinetic (PK) period, followed by approximately a 5 month treatment period. Subjects will receive weekly routine prophylactic therapy and on-demand treatment for bleeding episodes. In addition, subjects who are not on routine factor replacement therapy prior to the study will receive only on-demand treatment for bleeding episodes.

NCT ID: NCT01360021 Completed - Asthma Clinical Trials

New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day

BAI
Start date: November 2011
Phase: Phase 3
Study type: Interventional

This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.

NCT ID: NCT01359943 Completed - Clinical trials for Rheumatoid Arthritis

Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate

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

The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite treatment with Methotrexate.

NCT ID: NCT01358877 Active, not recruiting - Breast Cancer Clinical Trials

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

APHINITY
Start date: November 8, 2011
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).

NCT ID: NCT01358357 Completed - Bipolar I Disorder Clinical Trials

Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

PERSIST
Start date: June 2011
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.

NCT ID: NCT01358175 Active, not recruiting - Clinical trials for Ankylosing Spondylitis

16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis

MEASURE 1
Start date: October 2011
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

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: NCT01347671 Completed - Pain Clinical Trials

Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

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

The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.

NCT ID: NCT01347190 Completed - Cystic Fibrosis Clinical Trials

Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis

Start date: April 2011
Phase: Phase 1
Study type: Interventional

Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.

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