24 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 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 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 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.
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…
To assess the feasibility and efficacy of Carfilzomib in combination with Thalidomide and Dexamethasone in a phase II trial.
are sildenafil, metformin and simvastatin effective in stimulation of ADH independent urine concentration in man?
Primary objective: To compare progression-free survival (PFS) as assessed by blinded, central review between patients randomized to niraparib versus physician*s choice. Key secondary objective: To compare overall survival between patients randomized…
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.
To establish whether niraparib single agent treatment in advanced BRCA1-like, HER2 negative breast cancer patients deserves to be further studied
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…
Primary Objectives:- To determine the BE of a RS FDC tablet formulation of niraparib and Abiraterone Acetate with respect to niraparib and Abiraterone Acetate co-administered as single agents at steady state under modified fasted conditions in…
Dual Primary Objectives:• To compare progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) of niraparib plus pembrolizumab versus placebo…
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 objective:Evaulation of safety and tolerability of niraparibExploratory:Evaluation of the efficacy of niraparib relative to placebo as measured by disease-free survival (DFS)Evaluation of distant recurrence-free survival (DRFS)Time to first…
Objectives: The primary objectives of this study are: • Part 1 (dose-escalation): To evaluate the safety of SYD985 in combination with niraparib to determine the maximum tolerated dose (MTD) and recommended combination dose regimen for expansion (…
Primary objective:- To assess the efficacy of niraparib in subjects with measurable mCRPC and who have either biallelic DNA-repair anomalies in BRCA (BRCA 1 and BRCA 2 or germline BRCA. Secondary objectives:- To assess the efficacy of niraparib in…
As of protocol Amendment 06, evaluation of the safety profile of MLN9708 and/or other study medication is the only endpoint being assessed. All other study endpoints will no longer be assessed.
To compare efficacy, safety and quality of life of MP-Thal followed by thalidomide maintenance versus MP-Len followed by maintenance with lenalidomide