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NCT ID: NCT00168844 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Tiotropium / Respimat One-Year Study

Start date: January 2003
Phase: Phase 3
Study type: Interventional

To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.

NCT ID: NCT00168818 Completed - Thromboembolism Clinical Trials

Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

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

The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

NCT ID: NCT00168805 Completed - Clinical trials for Arthroplasty, Replacement, Knee

RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery

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

A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

NCT ID: NCT00168766 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS

Start date: January 2003
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.

NCT ID: NCT00168454 Completed - Clinical trials for Urinary Incontinence

A Research Study for Patients With Overactive Bladder

Start date: July 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.

NCT ID: NCT00167973 Completed - Hemophilia B Clinical Trials

Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use

Start date: January 2002
Phase: Phase 4
Study type: Observational

This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX. All patients who begin treatment with BeneFIX in European Union countries, will be eligible for participation. Patient demographics will be collected at baseline for all patients. A baseline FIX activity and Bethesda assay for inhibitor based on historical data should be recorded if available. Adverse events as defined in the protocol will also be reported on the appropriate forms. Data will be collected from patients on an ongoing basis to ensure that information is being captured for each patient being treated with BeneFIX.

NCT ID: NCT00166244 Completed - Clinical trials for De Novo Renal Transplant Recipient.

Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation

Start date: May 2003
Phase: Phase 4
Study type: Interventional

Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.

NCT ID: NCT00163540 Completed - Clinical trials for Encephalitis, Tick-borne

Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)

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

The objective of this study is to investigate the immunogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.

NCT ID: NCT00163475 Completed - Asthma Clinical Trials

Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)

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

Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma. The aim of the study is to compare the effect of roflumilast on lung function, symptoms, and use of rescue medication in patients with stable asthma. Roflumilast will be administered orally either in the morning or in the evening at one dose level. The study duration consists of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

NCT ID: NCT00163332 Completed - Asthma Clinical Trials

Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)

Start date: March 2003
Phase: Phase 3
Study type: Interventional

The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.