Kusajili – Centralise les essais cliniques mondiaux

A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2g per day of strontium ranelate versus alendronate 70mg per week in women with postmenopausal osteoporosis on bone microarchitecture measured by high resolution peripheral-Quantitative Computed Tomography (p-QCT) Assess the effects of strontium ranelate in comparison with alendronate on the bone microarchitecture in patients with postmenopausal osteoporosis

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Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 years To determine the optimal dose of ivabradine to reach the target heart rate reduction (HRR) of 20% without inducing a bradycardia (i.e. HR should be greater than a predefined HR threshold by age subset) and/or signs or symptoms related to bradycardia, ­To assess the pharmacokinetic (PK) parameters of ivabradine and its active metabolite S 18982 after repeated oral administrations, ­To assess the PKPD relationship of ivabradine and its active metabolite S 18982 using heart rate as evaluation criterion.

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