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NCT ID: NCT01340027 Completed - Urologic Diseases Clinical Trials

A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder

Symphony
Start date: March 29, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.

NCT ID: NCT01339923 Completed - Clinical trials for Meningococcal Disease

A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years

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

The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when administered alone without routine infant vaccines to healthy infants in their first year of life according to different two and three dose immunization schedules, which are suitable to be adopted by various national programs. This study will also investigate antibody persistence post primary series and administration of a subsequent booster dose of rMenB+OMV NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of age. This study will also evaluate the safety and immunogenicity of the concomitant administration of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and 12-month schedule.

NCT ID: NCT01339559 Completed - Epilepsy Clinical Trials

Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy

BRITE™
Start date: May 11, 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).

NCT ID: NCT01338831 Completed - Clinical trials for Metastatic Breast Cancer

Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer

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

The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D chosen, the study will enroll patients into the expansion portion of the study.

NCT ID: NCT01338753 Completed - Breast Neoplasms Clinical Trials

Study to Evaluate Markers of Response in Locally Advanced Breast Cancer

IMAGING
Start date: October 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the association between image and certain molecular markers with complete response in patients with locally advanced breast cancer, treated with neoadjuvant chemotherapy composed of Bevacizumab, Docetaxel and Doxorubicin.

NCT ID: NCT01338545 Completed - Clinical trials for Rheumatoid Arthritis

An Observational Study of Dosage Patterns in Routine Clinical Practice in Patients With Rheumatoid Arthritis (ACT-LIFE)

Start date: July 2010
Phase: N/A
Study type: Observational

This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from each patients for 12 months.

NCT ID: NCT01338415 Completed - Clinical trials for Pulmonary Arterial Hypertension

FUTURE 3 Study Extension

FUTURE 3 Ext
Start date: March 8, 2011
Phase: Phase 3
Study type: Interventional

The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).

NCT ID: NCT01338337 Completed - Clinical trials for Myelodysplastic Syndrome (MDS)

Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) Without the 5q Deletion and Transfusion Dependent Anaemia

ABRAZA
Start date: November 2010
Phase: Phase 2
Study type: Interventional

Primary Outcome Measures: • To evaluate the efficacy of treatment with Azacitidine in patients with transfusion-dependent, low risk International Prognostic Scoring System (IPSS) 0 int-1, Myelodysplastic Syndrome (MDS) without chromosome 5 (5q) deletion. The main objective will be based on the erythroid haematologic response according to International Working Group (IWG) 2006 criteria. Secondary Outcome Measures: - Haematologic response, bases on the following parameters: platelets, and neutrophils according to International Working Group (IWG) Criteria. - Medullary and cytogenetic response according to International Working Group (IWG) 2006 criteria. - The effect of treatment response on quality of life, through the Functional Assessment of Cancer Therapy-Anemia (FACT-an) questionnaire. - Overall survival, Event-Free Survival and the Acute Leukaemia Transformation Rate.

NCT ID: NCT01337765 Completed - Solid Tumor Clinical Trials

Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients

Start date: July 8, 2011
Phase: Phase 1
Study type: Interventional

This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BEZ235 and MEK162. Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.

NCT ID: NCT01337752 Completed - Multiple Myeloma Clinical Trials

Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

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

The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study.