The efficacy of SINGULAIR in favour of revelation of symptom of SAR be surrounded by means of earlier times demonstrated in placebo and active-controlled clinical cram of patients age 15 to 82 years. In these studies, SINGULAIR demonstrated constructiveness in swelling daytime nasal symptoms ranking, the opening endpoint, measured by means of the mediocre of personal score for nasal overloading, runny feeler, nasal itching and sneezing.
Safety profile of SINGULAIR in allergic rhinitis studies approximating that see beside placebo In clinical studies for both SAR and PAR, SINGULAIR was collectively in good Health tolerate with a sanctuary profile as good as to that of placebo for both be dark and adults. The rate of sleepiness was similar to placebo in all studies for adults and adolescents 15 years of age and elder with SAR and PAR. In these studies, the greatest profoundly tittle-tattle edge effects incorporated headache, ear contamination, hurt craw and upper respiratory infection. These letter assorted by age, and be reported at a frequency greater than or equal to two percent, and at an incidence greater than placebo in any the SAR or PAR studies.
ARTEMIS The sNDA submission include the 48-week efficacy and place of safety grades of ARTEMIS (AntiRetroviral Therapy with TMC114 Examined In improbable Subjects), a Phase 3, randomized, controlled, open-label study that associate the efficacy and safety of PREZISTA/r with the PI lopinavir/r in treatment-naive HIV-1-infected adult patients. Patients were randomized to receive a PREZISTA/r dose of 800 mg/100 mg once all day (an investigational dose) or, based on qualified dose in each countryside, any lopinavir/r 800 mg/200 mg once daily or 400 mg/100 mg twofold daily, plus an optimized background regimen (OBR) of tenofovir and emtricitabine once daily. Data from this study were presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago on September 18, 2007.
