23 results
The primary objective is to determine the effect of co-administration of telepravir, given as 2 tablets of 375 mg every 8 hours and DRV/rtv or fAPV/rtv on the amount of telaprevir and DRV/rtv or fAPV/rtv in the body. The secondary objective is to…
Primary objective: To evaluate the influence of fosamprenavir/ritonavir on single-dose pharmacokinetics of olanzapine in healthy volunteersSecondary objective: To evaluate the safety of fosamprenavir/ritonavir combined with single-dose olanzapine in…
To assess the efficacy of idebenone, compared to placebo, in improving or delaying the loss of respiratory function in patients with DMD
Primary: to demonstrate the superiority of at least one dose of canakinumab compared to placebo in reducing the risk of recurrent major cardiovascular disease events (cardiovascular death, non-fatal MI and stroke) in a population of clinically…
The primary objectives of this study are:Part II: to demonstrate that the time to flare in Part II is higher with canakinumab than with placebo.Part I: to assess if canakinumab allows tapering of steroids as per protocol in at least 25% of…
Primary: 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 in the target joint at 72 hours post-dose (on a 0-100mm VAS). To confirm that canakinumab…
Primary: Longterm safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
Primary: To determine whether IL-1 inhibition by Canakinumab is efficacious in treatment of Schnitzler syndrome.Secondary:1. To assess the effect of canakinumab on Schnitzler syndrome (clinical signs/symptoms and inflammatory biomarkers C-reactive…
Primary: Long term safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
The primary objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment they received during the randomised phase of the trial.The key secondary objective is to compare the rate of withdrawal from…
The purpose of this open-label phase III extension study is to collect additional long term safety and efficacy data on canakinumab in the treatment of SJIA from patients who qualify to roll-over into this study from the CACZ885G2305 and…
To assess the effect of ACZ885 on AAA size and growth rate as measured with ultrasound at 12 months.Secondary Objectives * To assess the safety and tolerability of monthly 150 mg subcutaneousdoses of ACZ885 in subjects with AAA over a treatment…
Primary: To determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteersSecondary: To determine the safety of combined use of fosamprenavir with posaconazole in healthy vol-unteers
- To gather long-term data on the safety and tolerability of idebenone inFriedreich*s Ataxia- To explore the effect of idebenone after longer term administration onneurological symptoms and signs as assessed by the InternationalCooperative Ataxia…
The primary objective of this study is:To demonstrate that the percentage of patients who meet the adapted ACR Pediatric 30 criteria at Day 15 is higher with canakinumab compared to placebo.Secondary objectives of this study are:* To evaluate the…
Primary: Safety run-in part (part 1):* to confirm tthe recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with docetaxel. Double-blind, randomized, placebo-controlled part (part 2):* to compare the overall survival (OS) between…
Primary: To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future dosesSecondary:* To characterize the pharmacokinetic profile of each investigational drug within each treatment arm…
Primary:* To assess the long-term safety of idebenone in DMD patients who completed the SIDEROS study.Secondary:* To describe the long-term evolution of respiratory function in idebenone-treated DMD patients who completed the SIDEROS study,…
Primary: The primary objective of the randomized treatment epoch and for the overall study is to demonstrate that subcutaneous canakinumab administered every 4 weeks is superior to placebo in achieving a clinically meaningful reduction of disease…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)