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NCT ID: NCT00477555 Completed - Clinical trials for Coronary Artery Bypass Grafting

Hemodynamic Assessment of Mosaic Ultra Stented Heart Valve in the Aortic Position

Start date: April 2006
Phase: N/A
Study type: Observational

The special fixation methodology of the Mosaic Ultra stented procine bioprosthesis allows valves to maintain their natural leaflet structure and root geometry which prevents leaflet calcification and improves hemodynamic performance and a potential for increased durability. This study will document the hemodynamic performance, as assessed by echocardiographic recordings, at six months post implantation.

NCT ID: NCT00477269 Completed - Clinical trials for Pulmonary Arterial Hypertension

Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension

Start date: April 2006
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the safety, tolerability, and efficacy of imatinib mesylate in patients with pulmonary arterial hypertension

NCT ID: NCT00476034 Completed - Osteoarthritis Clinical Trials

Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)

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

This 39-week, active controlled, study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2361 study.

NCT ID: NCT00475865 Completed - Multiple Sclerosis Clinical Trials

Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis

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

The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA]. The secondary objectives were: - to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters, relapse rate and patient-reported fatigue; - to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA.

NCT ID: NCT00475670 Completed - Breast Cancer Clinical Trials

A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer

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

This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by 3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

NCT ID: NCT00475566 Completed - Atherosclerosis Clinical Trials

A Safety and Efficacy Study of the Dynalink®-E Everolimus Eluting Peripheral Stent System

STRIDES
Start date: May 2007
Phase: N/A
Study type: Interventional

The purpose of this first-in-man study is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native superficial femoral and proximal popliteal lesions. Abbott Vascular is ceasing data analysis of the STRIDES Clinical Trial after 2 years. The decision to discontinue the study is not related to any safety concern. The rationale for this proposal is based on the following considerations: The performance of DYNALINK-E from STRIDES shows no device- or procedure-related deaths and no stent fractures, and the rate of additional revascularizations has been stable since approximately 14 months after the procedure. Evaluations of the bare metal nitinol DYNALINK and ABSOLUTE stents in the clinical literature show low rates of death, reintervention and stent fracture, which are consistent with STRIDES and demonstrate the safety of the nitinol stent platform of the DYNALINK-E. Long-term animal studies show no concerns with the drug or polymer coating of DYNALINK-E - everolimus tissue concentration drops below the quantifiable limit by approximately 17 months after implant, and vascular response to the coating is normal with widely patent lumens and struts incorporated into vessel tissue. The safety and performance of the DYNALINK-E has been substantiated by its clinical and pre-clinical data, and by the clinical data of similar products. Given the demonstrated mechanical integrity of the stent along with the evidence of a healthy long-term vascular response, there is a reasonable expectation of continued low event rates.

NCT ID: NCT00474786 Completed - Clinical trials for Renal Cell Carcinoma

Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

INTORSECT
Start date: September 2007
Phase: Phase 3
Study type: Interventional

This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

NCT ID: NCT00474058 Completed - Parkinson's Disease Clinical Trials

Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine

RECOVER
Start date: May 2007
Phase: Phase 3
Study type: Interventional

The objective of this trial is to assess the effects of transdermal rotigotine on the control of early morning motor function and sleep disorders compared to placebo in subjects with idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and non-motor symptoms of Parkinson´s disease will be evaluated.

NCT ID: NCT00474045 Completed - Diabetes Clinical Trials

Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes

Start date: May 2007
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combination with a short-acting insulin (insulin aspart).

NCT ID: NCT00472901 Completed - Clinical trials for Polymorphic Light Eruption (PLE)

Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)

Start date: May 2007
Phase: Phase 3
Study type: Observational

The purpose of this study is to determine whether the afamelanotide (CUV1647) formulation is effective in preventing PLE episodes or reducing the severity of PLE symptoms in patients with a well documented history of the disease. The study also aims to determine whether treatment with afamelanotide (CUV1647) can reduce the use of rescue medication in this group.