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NCT ID: NCT00481481 Completed - Transplantation Clinical Trials

Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects

CONCERTO
Start date: April 2007
Phase: Phase 3
Study type: Interventional

Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen.

NCT ID: NCT00481247 Completed - Clinical trials for Myeloid Leukemia, Chronic

A Phase III Study of Dasatinib vs. Imatinib in Patients With Newly Diagnosed Chronic Phase CML

DASISION
Start date: August 2007
Phase: Phase 3
Study type: Interventional

The purpose of this clinical research study is to compare the rate of confirmed complete cytogenetic response (cCCyR) of dasatinib to imatinib therapy within 12 months after randomization in newly diagnosed chronic phase Philadelphia positive chronic myeloid leukemia (Ph+ CML) patients. The safety of this treatment will also be studied.

NCT ID: NCT00481195 Completed - Clinical trials for Bipolar I Depression

Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

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

The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode.

NCT ID: NCT00480896 Completed - Dermatitis, Atopic Clinical Trials

Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

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

A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares.

NCT ID: NCT00479752 Completed - Colorectal Cancer Clinical Trials

Safety and Efficacy of Folfox4 + Weekly Cetuximab vs Folfox 4+Biweekly Cetuximab by Metastatic Colorectal Cancer

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

To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.

NCT ID: NCT00479401 Completed - Clinical trials for Early Parkinson Disease (Early PD)

Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

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

The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety, and tolerability of Pramipexole Extended Release (ER) (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole. In addition, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo, for assay sensitivity

NCT ID: NCT00478881 Completed - Overactive Bladder Clinical Trials

A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function

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

The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency. The study drug is to be taken in the form of tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug works better than no drug. The timing of visits for the study is as follows: the 1st visit (screening visit) at beginning of run-in-assessment with qualifying tests for patients: electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit (randomization visit). During visit this should be performed: urodynamic measurements (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final visit)-following test should be done: urodynamic measurements (filling cystometry and pressure flow investigations), ECG, safety laboratory and residual urine (by ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.

NCT ID: NCT00478023 Completed - Hysterectomy Clinical Trials

A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy

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

The main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR (tapentadol immediate release) compared to placebo in women undergoing abdominal hysterectomy.

NCT ID: NCT00477295 Completed - Epilepsy Clinical Trials

A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy

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

This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing regime to allow optimal zonisamide or carbamazepine therapy for individual subjects. Assessment of eligibility will take place at the Screening Visit. The subjects will be randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1 must occur as soon as possible (and at least within 14 days) of the Screening Visit in order to optimize subject care.

NCT ID: NCT00477282 Completed - Ovarian Cancer Clinical Trials

Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

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

The objective of this study is to assess the safety and efficacy of karenitecin versus topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer. Additionally, this study will assess the ability of karenitecin to extend the time to disease progression, extend the overall survival time, and reduce the incidence and severity of treatment related hematological toxicities in patients with advanced epithelial ovarian cancer.