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NCT ID: NCT00575003 Completed - Clinical trials for Perennial Allergy to House Dust Mite and/or Cat

Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

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

The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients.

NCT ID: NCT00574873 Completed - Clinical trials for Chronic Myeloid Leukemia

Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML

Start date: February 5, 2008
Phase: Phase 3
Study type: Interventional

Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

NCT ID: NCT00571649 Completed - Clinical trials for Venous Thromboembolism

Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

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

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

NCT ID: NCT00567190 Completed - Clinical trials for Metastatic Breast Cancer

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

CLEOPATRA
Start date: February 12, 2008
Phase: Phase 3
Study type: Interventional

This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment. Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.

NCT ID: NCT00566254 Completed - Clinical trials for Epilepsy; Paediatric Partial Onset Seizures

Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study)

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

The purpose of this study is to compare the safety and efficacy of zonisamide with 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: NCT00560378 Completed - Dermatitis, Atopic Clinical Trials

Long-term Safety of Protopic in Atopic Eczema

Start date: June 1998
Phase: Phase 3
Study type: Interventional

Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1%

NCT ID: NCT00560326 Completed - Dermatitis, Atopic Clinical Trials

Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis

Start date: June 2003
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.

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.

NCT ID: NCT00558259 Completed - Clinical trials for Venous Thromboembolism

Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE

RE-SONATE
Start date: November 2007
Phase: Phase 3
Study type: Interventional

The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).