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NCT ID: NCT00291889 Completed - Tuberculosis (TB) Clinical Trials

Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02 in Healthy PPD-negative Adults.

Start date: July 2004
Phase: Phase 1
Study type: Interventional

Vaccination against tuberculosis (TB) /healthy PPD-negative adults aged 18 to 45 years.Three doses of primary vaccination followed by a booster dose after completion of primary vaccination course. Booster vaccination will be given only to subjects receiving the candidate tuberculosis vaccines and not to the subjects receiving active comparators or control.

NCT ID: NCT00291876 Completed - Hepatitis A Clinical Trials

Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule

Start date: January 1, 2004
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine. This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 20. No additional subjects will be recruited during this long-term follow-up.

NCT ID: NCT00291655 Completed - Epilepsy Clinical Trials

Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).

Start date: June 2006
Phase: Phase 3
Study type: Interventional

For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe. To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.

NCT ID: NCT00291577 Completed - Breast Neoplasms Clinical Trials

Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer

Start date: July 2006
Phase: Phase 1
Study type: Interventional

This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.

NCT ID: NCT00291382 Completed - Asthma Clinical Trials

Airway Hyper-responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product

Start date: November 2005
Phase: Phase 4
Study type: Interventional

This double-blind, stratified, parallel group study is to determine whether aiming for 'Total control' results in better airway hyper-responsiveness than maintaining the treatment level at which 'Well-controlled' asthma was achieved. The primary endpoint is the mean change in PC20 methacholine. Well controlled subjects (as assessed after a 12 week run-in period) will enter a 24 week treatment period during which they will record PEF(Peak Expiratory Flow), symptoms, rescue beta2-agonist use over 24 hours, night time awakenings, asthma exacerbations, emergency visits due to asthma and Adverse Events. At every visit lung function measurements and airway hyper-responsiveness will be measured.

NCT ID: NCT00291330 Completed - Thromboembolism Clinical Trials

Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

RE-COVER I
Start date: February 2006
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

NCT ID: NCT00290953 Completed - Lung Cancer Clinical Trials

Evaluation of the Overall Survival of Meclinertant Versus Placebo After a First Line Chemotherapy With Cisplatin + Etoposide

SESAME
Start date: October 2002
Phase: Phase 2/Phase 3
Study type: Interventional

To demonstrate an increase in overall survival for patients with newly diagnosed extended stage small cell lung cancer when treated with SR48692 versus placebo, after an initial response (complete or partial response or stable) to first line cisplatin plus etoposide. Primary objective: comparison of overall survival between patients in the control arm and the meclinertant arm. Secondary objectives: comparison of the progression free survival, the time to progression, the clinical benefit, the quality of life, the toxicity and safety between patients in the control arm and the meclinertant arm.

NCT ID: NCT00290355 Completed - Clinical trials for Lung Cancer, Non-Small Cell

Study to Test the Efficacy of the Vaccine GSK 249553 in Treating Non-small-cell Lung Cancer After Tumour Removal by Surgery

Start date: May 28, 2002
Phase: Phase 2
Study type: Interventional

Patients will receive injections of GSK 249553 vaccine . Appropriate tests will be performed to assess the safety of the treatment and its ability to induce an immune response.

NCT ID: NCT00290264 Completed - Asthma Clinical Trials

SALTO - Symbicort Single Inhaler Therapy Use in Adolescent Adults and Adults With Persistent Asthma

Start date: December 2004
Phase: Phase 3
Study type: Interventional

The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adolescent and adult patients with persistent asthma.

NCT ID: NCT00289978 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

FREEDOMS
Start date: January 2006
Phase: Phase 3
Study type: Interventional

This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)