A one year open label, non comparative extension to a randomised, multicentre, phase II study to evaluate the asfety, tolerability, pharmacokinetics and effects on iron concentration of repeated doses of 5-10 mg/kg/day of ICL670 relative to deferoxamine in sickle cell disease patients with transfusional hemosiderosis Evaluate the long-term safety and tolerability profile of ICL670 in sickle cell disease patients with transfusional iron overload requiring chelation therapy

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A twelve week, randomized, double-blind, parallel-group multicentre study to evaluate the efficacy and safety of the combination of aliskiren/ramipril/amlodipine (300/10/10mg), compared to the combinations of ramipril/amlodipine (10/10mg) and aliskiren/amlodipine (300/10mg) in patients with essential hypertension and metabolic syndrome not adequately responsive to amlodipine 10mg The primary objectives of this study are: 1. To demonstrate that the combination of aliskiren / ramipril / amlodipine (300/10/10 mg) has superior efficacy compared to the combinations of ramipril / am...

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A multi-centre, randomised, double blind, parallel group study to investigate the efficacy and tolerability of treatment (24 weeks double blind phase followed by open-label extension) with either vildagliptin ( Galvus) or placebo combined with metformin in achieving optimal glycaemic control in older patients with type 2 diabetes To demonstrate superior HbA1c control rates (where control is defined as HbA1c= or <6.5%) after 24 weeks treatment in subjects given vildagliptin added to metformin compared to those given placebo add...

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A phase II, open-label, multicentre, 12 month study to evaluate the efficacy and safety of ranibizumab (0.5 mg) in patients with choroidal neovascularization secondary to pathological myopia (PM) To provide safety and efficacy data in patients with CNV secondary to PM using a guided individualised as-needed (PRN) dosage schedule. The mean change in best-corrected visual acuity (BCVA) from Ba...

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Neoadjuvant hormone therapy for postmenopausal women with ER and/or PgR positive primary breast cancer: A multi-center study to determine the optimum length of treatment with Femara (letrozole 2.5mg daily) on tumour regression to permit breast conserving surgery To determine the optimal treatment duration with letrozole (2.5 mg daily) preoperatively in order to permit breast conserving surgery in patients with early breast cancer, who are initially not suitab...

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A one year, open label, multi-center, extension study to CHTF919D2301 to assess the long term safety of tegaserod 6 mg bid given orally in female patients with symptoms of dyspepsia To evaluate the long gterm safety of tegaserod (6mg bid) at 6 months in female patients with symptoms of dyspepsia

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A 52-week extension to a multicenter, randomized, double-blind, active controlled study to compare the effect of 52 weeks treatment with LAF237 50 mg bid to metformin up to 1000 mg bid in drug naïve patients with type 2 diabetes Primary 1. To assess the long-term safety of LAF237 compared to metformin during 104 weeks of treatment. 2. To assess the long-term efficacy of LAF237 compared to metformin by evaluating the effect on...

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Ciclosporin and azathioprine treatment in severe ulcerative colitis: a double-blind controlled trial to evaluate short and long-term outcome Not provided at time of registration

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An extension to a phase II study to determine the safety and anti-leukemic effects of STI571 in patients with Philadelphia chromosome-positive leukemia including acute lymphoblastic leukaemia, acute myeloid leukaemia, and accelerated phase chronic myeloid leukemia •To enable patients to have access to study drug and continue study treatment •To decrease data collection to include overall survival and serious adverse events

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An Open label Randomised, multicentre study to evaluate the efficacy of two Zometa (Zoledronic acid) schedules on bone mineral density in prostrate cancer patients undergoing Androgen deprivation Therapy (ADT) The primary objective of this study is to compare the effect of intravenous Zometa® (zoledronic acid) 4 mg administered every 12 weeks (arm 1) versus every 24 weeks (arm 2) on bone loss associated wi...

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