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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: NCT00168701 Completed - Multiple Sclerosis Clinical Trials

Efficacy and Safety of BG00012 in MS

Start date: October 1, 2004
Phase: Phase 2
Study type: Interventional

Determine the efficacy, safety, and tolerability of BG00012 in MS patients.

NCT ID: NCT00168337 Completed - Clinical trials for Diabetic Macular Edema

A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

Start date: May 2005
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.

NCT ID: NCT00168103 Completed - Clinical trials for Hereditary Angioedema

Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks

Start date: June 2005
Phase: Phase 2/Phase 3
Study type: Interventional

HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of swelling of the larynx. This clinical Phase 2/Phase 3 study was designed to provide clinically relevant data on dosing, efficacy and safety in subjects with HAE.

NCT ID: NCT00168077 Completed - Clinical trials for Acquired Coagulation Factor Deficiency

Prothrombin Complex Concentrate for Anticoagulant Reversal

Start date: September 2005
Phase: Phase 3
Study type: Interventional

Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.

NCT ID: NCT00163527 Completed - Asthma Clinical Trials

Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)

Start date: April 2003
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 investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily. The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

NCT ID: NCT00163462 Completed - Asthma Clinical Trials

Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

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

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.

NCT ID: NCT00163449 Completed - Asthma Clinical Trials

Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)

Start date: November 2005
Phase: Phase 3
Study type: Interventional

The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

NCT ID: NCT00163436 Completed - Asthma Clinical Trials

Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)

Start date: September 2005
Phase: Phase 3
Study type: Interventional

The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).

NCT ID: NCT00163358 Completed - Asthma Clinical Trials

Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)

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

The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.