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NCT ID: NCT00496769 Completed - Atrial Fibrillation Clinical Trials

A Phase III Study of Apixaban in Patients With Atrial Fibrillation

AVERROES
Start date: August 31, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.

NCT ID: NCT00496002 Terminated - Hepatitis B Clinical Trials

Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus

QUASH 1
Start date: August 2007
Phase: Phase 3
Study type: Interventional

The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks and 96 weeks.

NCT ID: NCT00495885 Completed - Clinical trials for Sleep Initiation and Maintenance Disorders

Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus

SAMS12
Start date: June 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.

NCT ID: NCT00495066 No longer available - Melanoma Clinical Trials

Compassionate Use Trial for Unresectable Melanoma With Ipilimumab

Start date: n/a
Phase: N/A
Study type: Expanded Access

The primary objective of the study is to provide treatment with Ipilimumab to subjects who have serious or immediately life-threatening unresectable Stage III or Stage IV melanoma, who have no alternative treatment options, and whose physicians believe, based upon available data on benefit and risk, that it is appropriate to administer Ipilimumab at a dose of 3 mg/kg induction (with re-induction, if eligible), or for eligible subjects previously enrolled in Ipilimumab studies CA184-042, CA184-078, CA184-087, MDX010-16, or MDX010-20.

NCT ID: NCT00494338 Terminated - Clinical trials for Metastatic Prostate Cancer

Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer

Start date: November 2004
Phase: Phase 2
Study type: Interventional

A multi-center controlled, non-comparative open Phase II trial of docetaxel and celecoxib in patients with metastatic androgen independent prostate cancer where efficacy is measured by PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at least 4 weeks apart.

NCT ID: NCT00493298 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Tysabri Observational Program

TOP
Start date: June 29, 2007
Phase:
Study type: Observational

The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of Tysabri in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.

NCT ID: NCT00492245 Active, not recruiting - Keratitis Clinical Trials

Phototherapeutic Keratectomy (PTK) With Mitomycin in Adenoviral Opacities

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

The present study was designed to evaluate the treatment of adenoviral corneal opacities with PTK and mitomycin C.

NCT ID: NCT00491712 Active, not recruiting - Clinical trials for Neovascular Glaucoma

Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection

Start date: September 2005
Phase: N/A
Study type: Interventional

The management of neovascular glaucoma (NVG) is a challenge for the ophthalmologist and surgery is frequently needed to control IOP. The success rates of a drainage device is usually lower in NVG than in other forms of glaucoma. Triamcinolone intra-vitreous injections acetate has been used to treat macular edema secondary to diabetic retinopathy and central retinal vein occlusion and also to control inflammation in ophthalmologic surgeries. In the present study we will compare the outcome and complications of Silicone Ahmed Valve in GNV eyes with and without intra-vitreous triamcinolone injection.

NCT ID: NCT00490438 Recruiting - Clinical trials for Urinary Incontinence

Measurement of Vaginal Squeeze Pressure in Incontinent Patients

Start date: January 2007
Phase: N/A
Study type: Observational

The patients will be submited to a vaginal squeeze pressure measurements before and after surgeries for urinary incontinence.

NCT ID: NCT00490139 Completed - Neoplasms, Breast Clinical Trials

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

ALTTO
Start date: May 16, 2007
Phase: Phase 3
Study type: Interventional

This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema. The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). Secondary objectives include treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS). The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) should continue as planned with no changes.