18 results
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 objectives:To confirm the lack of effect of 0.5 mg sublingual testosterone on physiological and subjective measures of sexual arousal in women with HSDD. Secondary objective:To confirm the lack of effect of 0.5 mg sublingual testosterone on…
Primary objective1. To determine the effect of food on the pharmacokinetics of buspirone administered as the Lybridos formulationSecondary objective1. To evaluate the safety and tolerability of a single dose of Lybridos under fasted and fed…
Primary objective1. To determine the effect of food on the pharmacokinetics of sildenafil administered as the Lybrido formulation2. To determine whether >90% of the testosterone content is released after maximally 90 seconds after sublingual…
This study will investigate the counter impulse hypothesis. According to the counter-impulse hypothesis, avoidance motivation counters aggressive impulses. Consequently, this regulatory impact should be especially effective when people*s aggressive…
Primary Objective• To validate the existing demarcation formula (consisting of psychometric and biological markers) which predicts the sensitivity to Lybrido or Lybridos in women with female sexual interest/arousal disorder (FSIAD with or without…
Primary ObjectiveTo investigate the possible efficacy of combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in increasing sexual satisfaction during sexual activity in the domestic setting in healthy female subjects with…
To compare the pharmacokinetics of sublingual testosterone cyclodextrin followed by buspirone as an encapsulated tablet with administration of testosterone and buspirone as one tablet designed to release the components in a specific time-frame.
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…
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…
Primary objectives:To establish the lowest effective dose using physiological and subjective measures of sexual arousal.To evaluate and compare the pharmacokinetics of testosterone and its metabolites following administration of three (3) doses (0.…
Primary objective:To compare the pharmacokinetics of testosterone and sildenafil citrate following administration of a sublingual solution of testosterone with an encapsulated tablet versus a combination product.Secondary objective:To investigate…
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.
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…
Primary Objective: • To compare efficacy of once-weekly KRd (56 mg/m2 ) to twice-weekly KRd (27 mg/m2) in subjects with RRMM with 1 to 3 prior lines of therapyKey Secondary Objectives: • To compare progression-free survival (PFS) between treatment…
The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination…