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NCT ID: NCT00828867 Completed - Clinical trials for Infections, Bacterial

Single Dose Escalation First Time in Human PK Study

Start date: November 14, 2008
Phase: Phase 1
Study type: Interventional

This is a first time in human (FTIH) study of single escalating doses of investigational study drug to investigate safety, tolerability, and pharmacokinetics in healthy subjects

NCT ID: NCT00828737 Completed - Renal Impairment Clinical Trials

Safety of Gadovist in Renally Impaired Patients

GRIP
Start date: December 2008
Phase: Phase 4
Study type: Interventional

Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate. The administration of contrast agents that contain gadolinium such as Gadovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Gadovist. Patients who are enrolled in this study will receive a Gadovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.

NCT ID: NCT00825162 Completed - Influenza Clinical Trials

Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years

Start date: March 2009
Phase: Phase 4
Study type: Interventional

A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years

NCT ID: NCT00825149 Completed - Clinical trials for Non-Hodgkin's Lymphoma

A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma

GAUDI
Start date: February 2009
Phase: Phase 1
Study type: Interventional

This open-label, randomized, phase Ib study will assess the safety and efficacy of obinutuzumab given in combination with FC (fludarabine and cyclophosphamide) or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine induction chemotherapy in participants with Cluster of Differentiation (CD) 20+ B-cell Follicular Lymphoma (FL). Participants with complete response or partial response after induction therapy may receive maintenance therapy every 3 months for 2 years or until disease progression, whichever comes first. All participants in the induction period of the study will have a safety follow-up visit 28 days after completing the last dose of obinutuzumab + chemotherapy, and will be followed for at least 2 years, unless they are being treated in maintenance or discontinue from the study prior to this time point. Participants who complete/discontinue maintenance therapy will also be followed for a period of 2 years after receiving the last dose of obinutuzumab or until progression/new antilymphoma treatment.

NCT ID: NCT00824837 Completed - Renal Dialysis Clinical Trials

Study of beta2-Microglobulin Removal by Standard Versus New High Cut-Off Haemodialysis Membrane

HiCOF
Start date: October 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether a novel haemodialysis membrane, compared with the standard dialysis membrane, will increase the removal of beta2-microglobulin in chronic dialysis patients.

NCT ID: NCT00824434 Completed - Clinical trials for Coronary Artery Disease

A Prospective, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Elementâ„¢)

PLATINUM QCA
Start date: March 2009
Phase: Phase 3
Study type: Interventional

Compile acute (30-day) clinical outcomes data and 9-month angiographic and intravascular ultrasound (IVUS) data for the PROMUS Elementâ„¢ Everolimus- Eluting Coronary Stent System in the treatment of patients with a single de novo atherosclerotic lesion

NCT ID: NCT00824421 Completed - HIV-1 Clinical Trials

A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1

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

This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not been previously treated with antiretroviral drugs.

NCT ID: NCT00823212 Completed - Clinical trials for Coronary Artery Disease

The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions

PLATINUM
Start date: January 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Elementâ„¢ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. This clinical trial compares outcomes in patients treated with PROMUS Element to those in patients treated with a different everolimus-eluting coronary stent. The lesions are of average length in average-sized vessels ("workhorse"). A companion sub-trial evaluates outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions (LL).

NCT ID: NCT00820911 Completed - Clinical trials for Kidney Transplantation

Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients

Start date: September 2008
Phase: Phase 2
Study type: Interventional

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

NCT ID: NCT00818363 Completed - Postoperative Pain Clinical Trials

A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery

Start date: December 2008
Phase: Phase 2
Study type: Interventional

This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. The purpose of this study is to investigate safety (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.