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NCT ID: NCT01683604 Completed - Clinical trials for Rheumatoid Arthritis

Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis in Australia

Start date: July 2012
Phase: N/A
Study type: Observational

This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one biological agent. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from start of treatment.

NCT ID: NCT01682616 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Start date: July 25, 2012
Phase: Phase 1
Study type: Interventional

This is a Phase 1b, open-label, multicenter study evaluating the safety and tolerability of ABT-199 in combination with rituximab in up to 50 subjects with Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. The primary objectives of this study are to assess the safety profile, to determine the maximum tolerated dose and establish the Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab. The dose escalation portion of the study will include approximately 30 subjects. Once the recommended phase two dose and schedule have been determined, up to 20 additional subjects will be enrolled in an expanded safety portion of the study. Subjects who meet criteria for CR, CRi, or MRD-negative PR during the study may discontinue ABT 199. If disease progression occurs, as defined by iwCLL NCI/WG criteria for tumor response, or MRD progression, subjects may re-initiate ABT-199.

NCT ID: NCT01682083 Completed - Melanoma Clinical Trials

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

COMBI-AD
Start date: January 8, 2013
Phase: Phase 3
Study type: Interventional

This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.

NCT ID: NCT01681758 Completed - Cardiac Surgery Clinical Trials

An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients

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

We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in patients after cardiac surgery who are mechanically ventilated leads to a significant decrease in the amount of fluid given to such patients in the first 24 hours after surgery

NCT ID: NCT01678898 Completed - Fabry Disease Clinical Trials

Dose-ranging Study of PRX-102 in Adult Fabry Disease Patients

Start date: October 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is the first human treatment with PRX-102, an enzyme being developed as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be evaluated in this study of increasing doses. Patients will be treated with infusions every two weeks for 12 months.

NCT ID: NCT01677910 Completed - Carcinoid Syndrome Clinical Trials

TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)

Start date: January 8, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.

NCT ID: NCT01677754 Completed - Alzheimer's Disease Clinical Trials

A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy

MAyflOwer RoAD
Start date: October 24, 2012
Phase: Phase 2
Study type: Interventional

This Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4602522 in participants with moderate severity Alzheimer's disease. Participants who are taking background therapy of acetylcholinesterase inhibitors (AChEI) alone or in combination with memantine for at least 4 months before screening will be randomized to receive either one of two doses of RO4602522 or placebo for 12 months.

NCT ID: NCT01677741 Completed - Neoplasms, Brain Clinical Trials

A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects

Start date: May 23, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent patients with advanced BRAF V600 mutation-positive solid tumors. Part 1 was a dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). Part 2 was an expansion study to further evaluate the safety, tolerability, and clinical activity of dabrafenib in 4 tumor-specific pediatric populations. Patients participated in only either part 1 or part 2 of the study.

NCT ID: NCT01677676 Completed - Influenza A Clinical Trials

Safety, Tolerability and Immunogenicity of Two Different Formulations of an Influenza A Vaccine (FP-01.1)

Start date: January 2012
Phase: Phase 1
Study type: Interventional

This study has been designed to evaluate the safety and immunogenicity of two different formulations of FP-01.1 as well as build on the data set from the first in human study FP-01.1_CS_01. It is anticipated that the results of this Phase I study will inform the best formulation of the vaccine to evaluate in efficacy studies.

NCT ID: NCT01677052 Completed - Clinical trials for Symptomatic Atrial Fibrillation

THERMOCOOL® SMARTTOUCHâ„¢ Registry

Start date: August 2012
Phase: N/A
Study type: Observational

The primary purpose of this registry is to obtain "real world" clinical use of contact force measurements during ablation procedures.