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NCT ID: NCT00627523 Completed - Clinical trials for Infant, Small for Gestational Age

Genotropin Treatment In Very Young Children Born Small For Gestational Age

EGN
Start date: February 2008
Phase: Phase 3
Study type: Interventional

To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.

NCT ID: NCT00627146 Completed - Clinical trials for Diabetes Mellitus, Type 1

Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients

Start date: June 2000
Phase: Phase 2
Study type: Interventional

Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical onset of disease that persists until 48 months after administration. The investigators also hypothesize that in type 1 diabetic patients with recent clinical onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18 and 48 months after administration, based on assessment of clinical and laboratory adverse events.

NCT ID: NCT00626002 Completed - Clinical trials for Moderate to Severe Plaque Psoriasis

Open Label Continuation Study in Moderate to Severe Psoriasis

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

The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.

NCT ID: NCT00625664 Completed - Clinical trials for Urinary Bladder Neoplasms

Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

CILAB
Start date: February 2008
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.

NCT ID: NCT00625378 Completed - Neoplasms Clinical Trials

Sorafenib Long Term Extension Program

STEP
Start date: December 21, 2007
Phase: Phase 3
Study type: Interventional

The primary purpose of program was to enable patients, currently receiving sorafenib (Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study had met its primary endpoint and/or had reached the end as defined in the original protocol. Patients were able to continue treatment until (i) the treating physician felt the patient was no longer benefiting from the treatment or (ii) the treatment becomes commercially available and reimbursed for the respective indication as applicable in the country in which the patient lived and the patient could obtain suitable amounts of drug for treatment through standard mechanisms of commercial availability (ie, there should be no interruption in the patient's treatment schedule when switching to commercially available product) or (iii) the patient could join a Post-Trial-Access Program, another study or can receive sorafenib through any other mechanism (e.g. local access program) in accordance with local legal and compliance rules, with no cost to the patient with respect to sorafenib. An additional objective was the assessment of the safety of Nexavar or Nexavar combination treatment.

NCT ID: NCT00624351 Completed - Clinical trials for Systemic Lupus Erythematosus

Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

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

The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.

NCT ID: NCT00624286 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).

NCT ID: NCT00623623 Completed - Clinical trials for Myocardial Infarction

STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction

Start date: March 1, 2008
Phase: Phase 3
Study type: Interventional

This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B. The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated. All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.

NCT ID: NCT00623610 Completed - Clinical trials for Diabetes Mellitus, Type 1

Beta-Cell Transplantation in Pre-Uremic Patients With Type 1 Diabetes

Start date: September 2000
Phase: Phase 1/Phase 2
Study type: Interventional

To examine whether temporary immunosuppression with ATG, tacrolimus and MMF allows prolonged survival of beta cell allografts in type 1 diabetic patients with early chronic complications of diabetes.

NCT ID: NCT00623428 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

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

This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.