A randomized, double-blind, placebo-controlled, 4 period incomplete block cross-over, multi-center, multiple dose (7 days) dose-ranging study to assess the efficacy and safety of 4 doses of NVA237 in patients with stable Chronic Obstructive Pulmonary Disease (COPD), compared to seven days treatment with tiotropium (18µg once daily, open label) as an active control To evaluate the bronchodilatory efficacy of NVA237 in patients with stable COPD in terms of through FEV1 (mean of 23h 15 min & 23h 45 min post dose) following 7 days of treatment, by comparing four do...

• Country None
• organs None
• Specialty None

Novartis CZOL446EFR08 : Essai de phase 3 évaluant l’efficacité et la tolérance de l’acide zolédronique dans le traitement de la douleur induite par des métastases osseuses chez des patients atteints d’un cancer de la prostate. [Informations issues du site clinicaltrials.gov et traduites par l'INCa] [essai clos aux inclusions] L’objectif de cet essai est d’évaluer l’efficacité et la tolérance de l’acide zolédronique dans le traitement de la douleur induite par des métastases osseuses chez des patients atteints d’un cancer d...

• Country France
• organs Prostate, Métastases osseuses, Os
• Specialty Chimiothérapie

Study to assess the effects of a 3 week therapy each with QVA149 versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe COPD Primary objective:  To demonstrate that QVA149 (110/50 μg q.d.) is superior compared to placebo on peak inspiratory capacity (IC) after 21 days of treatment in patients with moderate to severe COPD....

• Country None
• organs None
• Specialty None

Multicentre, randomised, double-blind, parallel-group, placebo-controlled clinical trial, comparing nateglinide versus placebo to assess the efficacy and tolerability of nateglinide in patients with type two diabetes mellitus Not provided at time of registration

• Country None
• organs None
• Specialty None

A randomized, double-blind, multiple-dose, placebo-controlled, parallel group study to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of ACZ885 in patients with newly diagnosed type-1 diabetes mellitus (T1DM) • To assess the effect of ACZ885, in addition to standard of care, on the area under the curve of the stimulated C peptide after a mixed meal tolerance test conducted after 12 months’ treatment.

• Country None
• organs None
• Specialty None

A randomized, double-blind, controlled, parallel group, 12-week treatment study to compare the efficacy and safety of the combination of indacaterol 150 μg once daily with open label tiotropium 18 μg once daily versus open label tiotropium 18 μg once daily in patients with moderate to severe chronic obstructive pulmonary disease To demonstrate superiority of indacaterol 150 µg o.d. in combination with tiotropium 18 µg o.d. versus tiotropium 18 µg o.d. with respect to standardized AUC for FEV1 between 5 min – 8 h post-dose aft...

• Country None
• organs None
• Specialty None

A multinational, multicenter, randomized, double-blind, double-dummy, stratified, active controlled parallel group study comparing the efficacy and safety of intravenous zoledronic acid, 5 mg once yearly, and oral risedronate, 5 mg daily, in the prevention and treatment of corticosteroid induced osteoporosis to demonstrate that the percent change in lumbar spine BMD at Month 12 relative to baseline in male and female patients treated with one iv zoledronic acid 5 mg dose at randomization is not inferior ...

• Country None
• organs None
• Specialty None

Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children To assess the long-term safety and tolerability of omalizumab by measuring AEs, serious AEs, physical examination, medical history, laboratory assessments and vital signs

• Country None
• organs None
• Specialty None

A study of the BRAF inhibitor dabrafenib in combination with the MEK inhibitor trametinib compared to two placebos (inactive drugs) in the treatment of BRAF V600E/K mutation-positive melanoma after surgery To evaluate the efficacy of dabrafenib and trametinib combination therapy compared to two placebos with respect to relapse-free survival (RFS) in patients with completely resected, histologically conf...

• Country None
• organs None
• Specialty None

A randomized, controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective The two co-primary objectives of this study are: • To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to patient’s assessment of gout pain intensity...

• Country None
• organs None
• Specialty None