16 results
Primary objectiveTo investigate wether Sildenafil treatment results in a reduction of pulmonary artery pressure without decrease of cardiac output in HFpEF patients with PHSecondary objectivesTo investigate wether Sildenafil treatment results in a…
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 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…
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 aim of this pilot study is to assess if the sildenafil leads to an increase in tumour blood flow in NSCLC.
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…
The primary objective is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and T-cell ALL as measured by the complete response (CR) rate.The secondary…
are sildenafil, metformin and simvastatin effective in stimulation of ADH independent urine concentration in man?
Primary Objective:To assess the long-term safety and tolerability of soticlestat when administered as adjunctive therapy to standard of care (SOC) (eg, antiseizure medications [ASMs], vagus nerve stimulation, ketogenic diet, or modified Atkins diet…
Primary Objectives Efficacy: To demonstrate the superiority of InO monotherapy vs ALLR3 induction in paediatric participants between 1 and < 18 years with HR first bone marrow relapse CD22-positive BCP ALL Secondary Objectives:Key Secondary…
This study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone treatment (study treatments) in patients with advanced idiopathic pulmonary fibrosis (IPF) and intermediate or high probability of Group 3…
We aim to compare the effectiveness of sildenafil versus placebo in achieving healthy perinatal survival, in women with singleton pregnancies with severe fetal growth restriction of placental origin.
The main objectives of the trial are to:• evaluate the safety of venetoclax monotherapy.• determine dose limiting toxicities (DLT) and the recommended Phase 2 dose (RPTD) of venetoclax monotherapy.• assess the pharmacokinetics (PK) of venetoclax…
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…
Primary Objectives:• To assess the efficacy of soticlestat in reducing major motor drop (MMD) seizure frequency as add-on therapy to SOC as compared with placebo during the full treatment period (titration + maintenance).For European Medicines…
Primary Objectives:• To assess the efficacy of soticlestat in reducing convulsive seizure frequency as add-on therapy to SOC as compared with placebo during the full treatment period (titration + maintenance).• To assess the efficacy of soticlestat…