16 results
To determine whether treatment with RAD001 10 mg/d plus Sandostatin LAR® prolongs the progression free survival (PFS) compared to treatment with Sandostatin LAR® alone in patients with advanced carcinoid tumor.
The primary objective of this study is to demonstrate that the efficacy of rivaroxaban, a direct FXa inhibitor, is non-inferior to that of dose-adjusted warfarin for the prevention of thromboembolic events in subjects with non-valvular atrial…
To compare overall survival between RAD001+BSC and placebo+BSC in patients with advanced gastric cancer after progression on prior systemic chemotherapy.
The purpose of the trial is to determine the effect of multiple doses of tolvaptan on renal function in patients with autosomal dominant polycystic kidney disease (ADPKD) at various stages of renal function. Additionally, the short-term renal…
The primary objective of this trial is to demonstrate that aliskiren 300 mg, in addition to standard therapy, has superior efficacy compared to placebo in reducing the primary index of adverse cardiac remodeling (defined as the change in LVESV from…
Primary objective:* Evaluate long-term effect of tolvaptan in ADPKD through rate of renal volume change(%) for tolvaptan-treated compared to placebo-treated subjects.Secondary objectives:* Evaluate long-term efficacy of tolvaptan in ADPKD through a…
The primary objective of this study is to demonstrate the efficacy of the combination therapy of aliskiren (150 mg and 300 mg) and HCTZ 25 mg in hypertensive patients who do not show sufficient blood pressure response to a 4-week treatment of HCTZ…
To assess indacaterol (300 and 600 ug once daily via SDDPI) superiority in patients with COPD as compared to placebo with respect to 24 h post dose (through) FEV1 after 12 weeks of treatment.
Phase I- To characterize the safety and tolerability and determine the maximum tolerated dose of daily RAD001 in combination with daily sorafenibPhase II- To estimate the hazard ratio of the treatment effect as measure of anti-tumor activity of the…
The objective of this extension study is to find out the potential long-term benefits and safety of tolvaptan. During this study all participants will receive tolvaptan.PRIMARY OBJECTIVE is to demonstrate whether tolvaptan modifies ADPKD progression…
Primary: To demonstrate the superiority of secukinumab in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 90 responders at Week 16, compared to ustekinumab.Secondary: To demonstrate the superiority of secukinumab in…
Primary: To demonstrate that the efficacy of secukinumab 150 mg s.c. or 300 mg s.c., at Week 24 is superior to placebobased on proportion of subjects achieving ACR20 response in subjects with active PsA.Secondary:- mTTS structural damage week 24-…
To characterize safety, tolerability, pharmacodynamic effects, and pharmacokinetics of the oral sGC stimulator BAY 1021189 in addition to standard therapy for heart failure with reduced EF (HFrEF) over 12 weeks in patients with worsening chronic…
The purpose of this study is to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old…
Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the subgroup of patients who are TNF*…
Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response.Secondary (key only): ASAS40 week 16 response in…