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NCT ID: NCT01243177 Completed - Epilepsy Clinical Trials

Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older

SP0993
Start date: April 2011
Phase: Phase 3
Study type: Interventional

Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).

NCT ID: NCT01241760 Completed - Clinical trials for Genotype 1 Chronic Hepatitis C

VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection

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

The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

NCT ID: NCT01241591 Completed - Psoriasis Clinical Trials

A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

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

To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

NCT ID: NCT01240915 Completed - Colitis, Ulcerative Clinical Trials

A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis

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

MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells are believed to reduce inflammation and regulate immune system function, protect damaged or injured cells and tissue, promote formation of new blood vessels, and augment tissue repair and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of Graft versus Host Disease with almost complete reversal of gastrointestinal pathology (similar to pathology that would be expected in Ulcerative Colitis). These data, together with safety data generated in 2 other clinical trials, suggest that MultiStem has the potential to be a new treatment option for patients with ulcerative colitis. This is the first study of MultiStem in this patient population and will cautiously explore the safety/toleration and potential benefit of this new treatment in patients with moderate to severe disease.

NCT ID: NCT01239771 Completed - Clinical trials for Elderly Subjects 65 Years and Older, Healthy or With a Stable Disease and Treatment.

A Study to Assess Safety and Tolerability as Well as Absorption and Excretion of TC-5214 in Medically Stable Elderly Subjects

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

The purpose of the study is to assess safety, tolerability and pharmacokinetics of TC-5214 in medically stable elderly subjects following multiple oral doses.

NCT ID: NCT01239732 Completed - Ovarian Cancer Clinical Trials

A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer

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

This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Patients will receive 15 mg/kg Avastin intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (AUC 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 mg/m2 on Day 1 every 3 weeks or 80 mg/m2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.

NCT ID: NCT01238640 Completed - Tobacco Dependence Clinical Trials

Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab

Start date: August 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.

NCT ID: NCT01238627 Completed - Tobacco Dependence Clinical Trials

Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg

Start date: September 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg.

NCT ID: NCT01237743 Completed - Aortic Stenosis Clinical Trials

Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation.

Start date: July 2009
Phase: N/A
Study type: Observational

Transcatheter Aortic Valve Implantation (TAVI) using femoral access is an option for definitive treatment of aortic stenosis when open-heart surgery is considered inappropriate. By avoiding the effects of cardiopulmonary bypass on cerebral hemodynamics and microembolic load, TAVI is assumed to be beneficial regarding risk for neurological complications. We anticipated that the extensive endovascular retrograde manipulation in ascending aorta and aortic root would generate a detectable cerebral microembolic load, and thus an increase in serological markers of neuronal injury postoperatively. Our hypothesis is that there is a positive correlation between the total amount of cerebral microembolic events during the TAVI procedure and the Area under curve (AUC24hrs) for the release pattern of two markers of neuronal injury. We also wish to describe the extent and distribution of microembolisms during the TAVI procedure using Transcranial Doppler (TCD).

NCT ID: NCT01235598 Completed - Clinical trials for Rheumatoid Arthritis

Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)

MARVELOUS
Start date: December 2010
Phase: Phase 3
Study type: Interventional

Phase IIIb study to determine early response to Certolizumab Pegol (CZP) with Magnetic Resonance Imaging (MRI) score Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials (OMERACT) RA MRI Scoring System (RAMRIS) in subjects with RA.