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NCT ID: NCT01331837 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

Start date: August 2011
Phase: Phase 4
Study type: Interventional

This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).

NCT ID: NCT01330316 Completed - Hepatitis C Clinical Trials

A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients

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

The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.

NCT ID: NCT01329029 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)

REACT
Start date: May 2011
Phase: Phase 4
Study type: Interventional

The objective of the REACT trial is to investigate the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate and pulmonary function in COPD patients who are concomitantly treated with a fixed combination of long-acting β2-agonists (LABA) and inhaled glucocorticosteroids (ICS). In addition, data on safety and tolerability of roflumilast will be obtained. An additional objective is to further characterize the population pharmacokinetic profile of roflumilast and roflumilast N oxide and to further characterize their pharmacokinetics/pharmacodynamics (PK/PD) relationship in terms of efficacy and relevant safety aspects. Patients to be included are required to have severe COPD associated with chronic bronchitis and a history of frequent exacerbations and must be concomitantly treated with a fixed combination of LABA and ICS. Two parallel treatment arms (roflumilast 500 μg once daily and placebo) are included.

NCT ID: NCT01328600 Completed - Preeclampsia Clinical Trials

Marinobufagenin as a Target for DIGIBIND in Preeclampsia

Start date: August 16, 2006
Phase:
Study type: Observational

Background: - Preeclampsia is a combination of high blood pressure and other potentially life-threatening symptoms. Preeclampsia occurs in up to 10% of pregnancies and is a main cause of maternal and fetal death worldwide. Treatment is often difficult, and so far there is no specific and effective therapy. Researchers have been studying the body systems that regulate blood pressure. They have also studied drugs that can control certain blood chemicals that constrict blood vessels and increase blood pressure. - DIGIBIND, a drug that lowers blood pressure, has been used to treat pre-eclampsia. Marinobufagenin (MBG), a chemical in the blood that constricts blood vessels, has been shown to be involved in pre-eclampsia. But researchers are still not certain whether DIGIBIND can be used to specifically target MBG. Researchers want to find out whether DIGIBIND acts against MBG specifically. This information may help them to develop better drugs to block MBG and lower blood pressure in women with preeclampsia. Objectives: - To study whether the blood pressure treatment drug DIGIBIND specifically acts on marinobufagenin levels in the blood of pregnant women. Eligibility: - Women between 18 and 50 years of age who are 34 to 39 weeks pregnant and have preeclampsia. Design: - Participants will be screened with a physical examination, medical history, and blood and urine tests. - Before delivery, participants will provide blood samples for testing and evaluation. - Following delivery, participants will provide additional blood samples and samples of the placenta for testing and evaluation. - No additional treatment, apart from the standard of care, will be provided as part of this protocol.

NCT ID: NCT01328444 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444. Study A

COPD
Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination and component, two-period, incomplete block design cross-over study using GSK573719/GW642444. The primary objective is to evaluate lung function and exercise endurance time after 12 weeks of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and 62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25 mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI)

NCT ID: NCT01327885 Completed - Soft Tissue Sarcoma Clinical Trials

Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

Start date: March 10, 2011
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.

NCT ID: NCT01327846 Completed - Atherosclerosis Clinical Trials

Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)

CANTOS
Start date: April 11, 2011
Phase: Phase 3
Study type: Interventional

Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events. The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase. Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS). Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.

NCT ID: NCT01324947 Completed - Multiple Myeloma Clinical Trials

Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma

Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone due to disease progression.

NCT ID: NCT01324128 Completed - Clinical trials for Chronic Kidney Disease Requiring Chronic Dialysis

A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients

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

This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.

NCT ID: NCT01323634 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease

Start date: March 18, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.