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NCT ID: NCT01549964 Terminated - Glycemic Control Clinical Trials

Comparison of TAK-875 to Placebo and Sitagliptin in Combination With Metformin in Participants With Type 2 Diabetes

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

The purpose of this study is to evaluate the efficacy of 2 doses of TAK-875 (25 mg and 50 mg), once daily (QD), plus metformin compared to placebo plus metformin and sitagliptin plus metformin on lowering blood sugar.

NCT ID: NCT01545817 Terminated - Clinical trials for Carcinoma, Renal Cell

Everolimus Post Pazopanib Treatment in Metastatic or Advanced Renal Cell Carcinoma

CATChEz
Start date: April 19, 2012
Phase: Phase 2
Study type: Interventional

Study to determine the efficacy, safety and tolerability of first-line pazopanib followed by second-line everolimus in metastatic and advanced renal cell carcinoma. Due to changes in the RCC treatment landscape, info gained is no longer clinically relevant to patients. Data collected is deemed sufficient to meet objective.

NCT ID: NCT01541670 Terminated - Clinical trials for Systemic Lupus Erythematosus

Safety Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Lupus Nephritis

Start date: November 28, 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of Anti-MIF Antibody in subjects with lupus nephritis.

NCT ID: NCT01536418 Terminated - Crohn's Disease Clinical Trials

An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease

SHIELD-4
Start date: November 11, 2011
Phase: Phase 3
Study type: Interventional

This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.

NCT ID: NCT01529034 Terminated - Epilepsy Clinical Trials

Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters

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

The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

NCT ID: NCT01526928 Terminated - Clinical trials for Locally Advanced or Metastatic Non Small Cell Lung Cancer

Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients

Start date: March 27, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.

NCT ID: NCT01524887 Terminated - Alzheimer´s Disease Clinical Trials

Phase 3 IGIV, 10% in Alzheimer´s Disease

Start date: January 23, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide evidence of efficacy and safety to support the development of IGIV, 10% as a treatment option for patients with mild to moderate Alzheimer´s Disease.

NCT ID: NCT01522443 Terminated - Prostate Cancer Clinical Trials

Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer

COMET-2
Start date: March 2012
Phase: Phase 3
Study type: Interventional

Bone metastases and associated pain are a major cause of morbidity and mortality in castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated by lack of resolution of lesions on bone scan with these agents) or the pain associated with these metastases. This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC.

NCT ID: NCT01522170 Terminated - Clinical trials for Atypical Hemolytic Uremic Syndrome

aHUS Observational Long Term Follow-Up

LTFU
Start date: March 2012
Phase: N/A
Study type: Observational [Patient Registry]

There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.

NCT ID: NCT01521143 Terminated - Clinical trials for Epithelial Ovarian Cancer

Cvac as Maintenance Treatment in Patients With Epithelial Ovarian Cancer in Complete Remission Following First-line Chemotherapy or Second-line Treatment

CANVAS
Start date: January 2012
Phase: Phase 2
Study type: Interventional

As < 10% of the necessary patients required by the protocol were recruited and the data were not intended to support a labeling claim, it was determined that the abbreviated clinical study report (CSR) was the appropriate reporting format. No efficacy analyses were performed as the trial was terminated early with incomplete enrollment of < 10%. The purpose of this study is to determine if an investigational cell therapy called Cvac can help epithelial ovarian cancer (EOC) from returning when administered to patients who are in complete remission after surgical removal of their tumor followed by standard first-line (Part A) or second-line (Part B) chemotherapy. Following remission, patients will undergo leukapheresis for the manufacture of the study agent. After completion of chemotherapy and confirmation of remission, patients will enter the treatment phase of the study.