NCT03545997 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cereza G, Garcia Doladé N, Laporte JR
Nightmares induced by montelukast in children and adults. Eur Respir J. 2012 Dec;40(6):1574-5. doi: 10.1183/09031936.00092812.
Goldbart AD, Greenberg-Dotan S, Tal A
Montelukast for children with obstructive sleep apnea: a double-blind, placebo-controlled study. Pediatrics. 2012 Sep;130(3):e575-80. doi: 10.1542/peds.2012-0310. Epub 2012 Aug 6.
Ingelsson E, Yin L, Bäck M
Nationwide cohort study of the leukotriene receptor antagonist montelukast and incident or recurrent cardiovascular disease. J Allergy Clin Immunol. 2012 Mar;129(3):702-707.e2. doi: 10.1016/j.jaci.2011.11.052. Epub 2012 Jan 12.
Marchand M-S, Jonville-Béra A-P, Autret-Leca E
[Psychiatric disorders associated with montelukast: data from the National Pharmacovigilance Database]. Arch pe´diatrie organe Off la Socie´te Fr pe´diatrie [Internet]. 2013 [cited 2016 Jun 14];20:269-73. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23375423

Impact of Blocked Cysteinyl Leukotriene Pathway on Endothelial Function in Patients With Obstructive Sleep Apnea Syndrome: Multicenter Randomized Placebo Controlled Crossover Trial

Details for clinical trial NCT03545997

Clinical trial NCT03545997 - References