6 results
The primary objective is to assess the proportion of patients in each treatment arm with a satisfactory clinical response as defined by a composite primary endpoint at Week 24.The secondary objective is to demonstrate safety and clinical effect at…
To measure APC resistance and SHBG levels as indicators of the risk of venous thrombosis during use of the new developed combined oral contraceptive containing dienogest/estradiolvalerate (Qlaira®) compared with a combined oral contraceptive…
Main objective:To explore the impact of setmelanotide on obesity in patients with various specific rare genetic mutations.Secondary objective:To assess the effects of setmelanotide on:* Safety and tolerability-Hunger* Waist circumferenceOptional sub…
Primary objective: To demonstrate pharmacokinetic comparability of 3D-printed sildenafil tablets and the originator sildenafil tablets following a single 20 mg dose in healthy adult subjects.Secondary objectives:• To describe the plasma…
To determine the most effective drug (iNO or IV sildenafil) for the treatment of PH in newborns with CDH and to reach evidence based dosing of this drug. Subsequently this drug will be added to the international guidelines for the treatment of…
To characterize safety and tolerability of setmelanotide in patients who have completed treatment in a previous trial of setmelanotide for obesityassociated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway and…