10 results
Primary Safety Objective * Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602*2403 mg/d and nintedanib at a dose of 200*300 mg/d Secondary Safety Objective * Proportion of patients who discontinue…
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…
The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…
Part A:To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeksPart B:• To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of RA at 24…
our main objective is to determine whether additional folic acid to ferrous fumarate contributes to the increase of haemoglobin and the improvement of health status in post partum anaemia. Our second objective is to asses what the difference in…
In the proposed study, two main issues will be addressed: first, it will be studied whether a high dose (4.0 mg) of FA supplementation periconceptional has an added value over the now recommended low dose of 0.4 mg in the prevention of congenital…
Effect of folic acid supplementation in pregnancy on preeclampsia - Folic Acid Clinical
Trial (FACT)
Primary ObjectiveThe overall aim is to evaluate a new preeclampsia (PE) prevention strategy: 4.0mg (1.0mg x 4) of folic acid supplementation vs. placebo from early (80/7 to 166/7 weeks of gestation) pregnancy until delivery.Secondary ObjectivesTo…
Primary objectiveThe primary objective is to evaluate the effect of Pirfenidone on the change in FEV1 over 6 months in lung transplant recipients with BOS, who are treated with Azithromycin.Secondary objectives The secondary objectives involve the…
to investigate the safety and tolerability of pirfenidone in asbestosis patients
The main goal of the proposed project is to compare two MTX dosing regimens to suppress ADA levels in patients with inflammatory bowel disease (IBD) with loss of response to anti-TNF agents, and to relate these findings to clinical and biochemical…