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NCT ID: NCT00565409 Completed - Clinical trials for Arthritis, Rheumatoid

Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

PRESERVE
Start date: March 2008
Phase: Phase 4
Study type: Interventional

To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.

NCT ID: NCT00564681 Completed - Cervical Dystonia Clinical Trials

Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia

Start date: December 2007
Phase: Phase 2
Study type: Interventional

Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and placebo.

NCT ID: NCT00563381 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients.

Start date: January 2008
Phase: Phase 4
Study type: Interventional

This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week randomised treatment phase. Patients who withdraw prematurely from trial medication will be encouraged to remain in the trial and participate in follow-up telephone contacts until their predicted normal exit date from the trial (i.e. 52 weeks after taking the first dose of randomised treatment). The phone calls will be made at all scheduled visits. The primary objective of this study is to compare the effect of tiotropium (18 mcg) inhalation capsule via HandiHaler with that of salmeterol (50 mcg) via MDI on COPD exacerbations. The primary endpoint is time to first COPD exacerbation during the 52 week randomised treatment period. A COPD exacerbation will be defined as a complex of respiratory events / symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnoea or chest tightness with at least one symptom lasting at least three days requiring treatment with antibiotics and/or systemic steroids and/or hospitalisation. The onset of an exacerbation is defined as the onset of the first new or increased reported symptom. The end of the exacerbation should be recorded as defined by the investigator. Only COPD exacerbations with onset during randomised treatment will be included in the analysis.

NCT ID: NCT00561925 Completed - HIV Infections Clinical Trials

VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients

Start date: November 2007
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.

NCT ID: NCT00561470 Completed - Clinical trials for Colorectal Neoplasms

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen

VELOUR
Start date: November 2007
Phase: Phase 3
Study type: Interventional

The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease. The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.

NCT ID: NCT00559910 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

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

PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.

NCT ID: NCT00559585 Completed - Clinical trials for Rheumatoid Arthritis (RA)

Methotrexate-Inadequate Response Study

Start date: January 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.

NCT ID: NCT00559273 Completed - Anemia Clinical Trials

A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis.

Start date: December 2007
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Patients will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kg, or darbepoetin alfa once weekly, at a starting dose of 0.45 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00558363 Completed - Neoplasms, Prostate Clinical Trials

ARTS - AVODART After Radical Therapy For Prostate Cancer Study

ARTS
Start date: November 2007
Phase: Phase 2
Study type: Interventional

ARI109924 will be a 2-year, multicentre, randomised, double-blind, placebo-controlled trial assessing the efficacy and safety of dutasteride in extending time to prostate specific antigen (PSA) doubling in men who have been treated for clinically localised prostate cancer (PCa) with a radical therapy (radical prostatectomy, primary radiotherapy or salvage radiotherapy) with curative intent but who experience a biochemical failure (PSA rise) afterwards without signs or symptoms of metastases.

NCT ID: NCT00558311 Completed - Clinical trials for Aneurysmal Subarachnoid Hemorrhage

Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping

CONSCIOUS-2
Start date: December 14, 2007
Phase: Phase 3
Study type: Interventional

The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at 5 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm -related morbidity and all-cause mortality within 6 weeks post-aSAH treated by surgical clipping. The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the following: 1. Death (all causes). 2. New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm. 3. Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm. 4. Neurological signs or symptoms (depending on state of consciousness), in the presence of confirmed cerebral vasospasm on angiography (DSA or CTA), leading to the administration of a valid rescue therapy. An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.