11 results
Primary: to assess the efficacy of ambrisentan 5mg after treatment period of 16 weeks, in subjects with inoperable CTEPH. Secondary: safety and tolerability.
The primary objective of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with PAH. This will be assessed by time…
Primary: Longterm safety and tolerability of 2 dosages of ambrisentan. Secundary: Supportive efficacy data.
The purpose of this current study is to evaluate the efficacy and safety of the 3-day oral aprepitant regimen when administered concomitantly with ondansetron, with or without dexamethasone, in pediatric patients, from 6 months to 17 years of age,…
Primary: to assess the longterm safety and tolerability of ambrisentan 5mg in subjects with inoperable CTEPH. Secondary: to collect supportive efficacy data.
Primary: Safety and tolerability of 2 dosages of ambrisentan. Secundary: Efficacy and PK.
The primary objective is to study the effect of oral Ondansetron and oral rehydration therapy on the number of referrals to a pediatric emergency department in children aged 6 months to 6 years attending an out-of-hours primary care service (OHS)…
The objective of the study is to evaluate the efficacy and safety of a single dose of fosaprepitant when administered concomitantly with ondansetron, with or without dexamethasone, in subjects birth to 17 years of age receiving emetogenic…
The primary objective is to determine the added effect of oral ondansetron to care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4 hours after presentation at an out-of-hours primary care service (OHS) in children aged 6…
All efficacy study objectives will be assessed in the pediatric AS study population of subjects who are 4 to 12 years old. All safety study objectives will be assessed in the pediatric AS study population of subjects who are 2 to 12 years old.…
The primary objective of this study is to evaluate the long-term safety and tolerability of OV101 in individuals with AS assessed by the incidence and severity of AEs and SAEs in subjects who are at least 2 years old.The secondary objectives of this…