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NCT ID: NCT00291330 Completed - Thromboembolism Clinical Trials

Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

RE-COVER I
Start date: February 2006
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

NCT ID: NCT00290953 Completed - Lung Cancer Clinical Trials

Evaluation of the Overall Survival of Meclinertant Versus Placebo After a First Line Chemotherapy With Cisplatin + Etoposide

SESAME
Start date: October 2002
Phase: Phase 2/Phase 3
Study type: Interventional

To demonstrate an increase in overall survival for patients with newly diagnosed extended stage small cell lung cancer when treated with SR48692 versus placebo, after an initial response (complete or partial response or stable) to first line cisplatin plus etoposide. Primary objective: comparison of overall survival between patients in the control arm and the meclinertant arm. Secondary objectives: comparison of the progression free survival, the time to progression, the clinical benefit, the quality of life, the toxicity and safety between patients in the control arm and the meclinertant arm.

NCT ID: NCT00289978 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

FREEDOMS
Start date: January 2006
Phase: Phase 3
Study type: Interventional

This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)

NCT ID: NCT00289926 Completed - Quality of Life Clinical Trials

Efficacy and Safety of Oral DHEA Therapy for Postmenopausal Women on Sexual Function, Wellbeing and Vasomotor Symptoms

Start date: February 2006
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the efficacy and safety of oral Dehydroepiandrosterone (DHEA) 50mg daily, for 12 months in naturally menopausal women with low libido who are not receiving systemic oestrogen or oestrogen- progestin therapy. Efficacy measures for the present study are effects on sexual function, wellbeing and menopausal symptoms. Safety measures will include endometrial assessment by transvaginal ultrasound (TVU), vital signs, lipid profiles, general electrolytes, effects on glucose metabolism and reports of adverse events.

NCT ID: NCT00289783 Completed - Clinical trials for Haemophilus Influenzae Type b

Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

Start date: February 22, 2006
Phase: Phase 3
Study type: Interventional

This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.

NCT ID: NCT00289640 Completed - Melanoma Clinical Trials

Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

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

The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.

NCT ID: NCT00289198 Completed - Clinical trials for Rhinitis, Allergic, Perennial

Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)

Start date: February 7, 2006
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).

NCT ID: NCT00288834 Completed - Stroke Clinical Trials

Outcomes of Swallowing Rehabilitation After Stroke

Start date: August 2001
Phase: N/A
Study type: Interventional

This project proposes to evaluate the relative effectiveness of four therapy protocols for pharyngeal phase swallowing impairment in the stroke population. Data derived from this study should contribute significantly to our understanding of the rehabilitative process in the neurogenic dysphagic population and will provide the foundation for the establishment of efficacious, cost-efficient patient services. 1. Research Question to be addressed 1. The utilization of SEMG biofeedback monitoring in dysphagia rehabilitation facilitates more rapid and complete recovery than traditional rehabilitation using the same swallowing exercises without exteroceptive feedback. 2. Swallowing rehabilitation provided in an intensive rehabilitative programme (10 hrs of treatment in the 1st week) facilitates more rapid and complete recovery than traditionally scheduled swallowing rehabilitation (twice weekly).

NCT ID: NCT00288236 Completed - Clinical trials for Type 2 Diabetes Mellitus

Study Evaluating Rimonabant Efficacy in Insulin-Treated Diabetic Patients(ARPEGGIO)

Start date: January 2006
Phase: Phase 3
Study type: Interventional

Primary: Effect on HbA1c over 48 weeks in insulin-treated patients with type 2 diabetes Secondary: Effect on glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides - Safety, tolerability

NCT ID: NCT00287261 Completed - Myelofibrosis Clinical Trials

A Trial of Zoledronic Acid in Patients With Myelofibrosis With Myeloid Metaplasia (MMM)

Start date: February 2006
Phase: Phase 2
Study type: Interventional

In this trial, the question is addressed if zoledronic acid (Zometa, Novartis Pharma)could be of clinical benefit for patients with myelofibrosis and myeloid metaplasia (MMM).