Examples of using Active-controlled study in English and their translations into German
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Results at Week 52(LOCFa) in an active-controlled study comparing dapagliflozin to glipizide as add-on to metformin.
The safety and efficacy of Oncaspar was evaluated in an open-label, multicenter,randomized, active-controlled study Study 1.
In the active-controlled study, audiology testing was performed in selected centres accounting for about a quarter of the study population.
The EMA submission is based on the positive results from the Phase 3 VIBRANT trial, which was a double-masked,randomized, active-controlled study of patients with macular edema secondary to BRVO.
BRIGHTER was a 3-arm randomised active-controlled study that compared 0.5 mg ranibizumab given as monotherapy or in combination with adjunctive laser photocoagulation to laser photocoagulation alone.
One hundred and twenty-nine new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with Enbrel for up to approximately 6 years,including 231 patients treated with Enbrel in combination with methotrexate in the 2-year active-controlled study.
HbA1c at week 24 in active-controlled study comparing the combination of saxagliptin and dapagliflozin added concurrently to metformin with either saxagliptin or dapagliflozin added to metformin.
Efficacy of Lyxumia was also assessed in two randomised,open-label, active-controlled study(versus exenatide or versus insulin glulisine) and in a meal time study in total 1,067 patients randomised to lixisenatide.
In the active-controlled study(the DECIDE study), 919 patients received Zinbryta(150 mg, every 4 weeks) and 922 patients received interferon beta-1a intramuscular,(30 microgram weekly) for a minimum of 2 years and up to 3 years.
The first pivotal(phase III)clinical study XM22-03 was an active-controlled study in 202 patients with stage II-IV breast cancer receiving up to 4 cycles of chemotherapy consisting of doxorubicin and docetaxel.
In the active-controlled study, at least 89% of patients had P. aeruginosa isolates with MICs at least 15 times lower than mean post-dose sputum concentration, both at baseline and at the end of the third active treatment cycle.
Rasitrio was studied in a double-blind, randomised, active-controlled study in 1,181 patients of which 773 were classified as moderately hypertensive(msSBP 160-180 mmHg) and 408 as severely hypertensive(msSBP> 180 mmHg) at baseline.
In the 2-year active-controlled study where patients were treated with either Enbrel alone, methotrexate alone or Enbrel in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
In addition, a randomised, blinded assessor, active-controlled study compared ustekinumab and etanercept in patients with moderate to severe plaque psoriasis who had had an inadequate response to, intolerance to, or contraindication to ciclosporin, MTX, or PUVA.
FISSION was a randomised, open-label, active-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin compared to 24 weeks of treatment with peginterferon alfa 2a and ribavirin in treatment-naïve subjects with genotype 2 or 3 HCV infection.
FLUENZ has demonstrated superiority in 3 active-controlled studies with injectable influenza vaccine.
The safety and efficacy of Eylea were assessed in two randomised, multi-centre,double-masked, active-controlled studies in patients with DME VIVIDDME and VISTADME.
Across the active-controlled studies, dosing with IONSYS was similar to intravenous PCA morphine pump use.
The efficacy and safety of IONSYS for treatment of acute, moderate to severe postoperative pain was evaluated in seven controlled studies in 1763 IONSYS patients:three placebo-controlled studies and four active-controlled studies.
In three active-controlled studies, in nearly 1000 adult patients with mild-to-moderate asthma, the effect of montelukast(10 mg once daily) was shown to be better than that obtained with placebo, but less than that obtained with inhaled beclometasone dipropionate 400 µg/ day.
The efficacy and safety of Numient in patients with advanced stage Parkinson's diseasehave been evaluated in 2 double-blind, active-controlled studies: parallel study ADVANCE-PD(study IPX066-B09-02; 22 weeks) and cross-over study ASCEND-PD study IPX066-B-09-06 Part 1; 11 weeks.
A higher dose of umeclidinium/vilanterol(113/22 micrograms) was also studied in a 24-week placebo controlled clinical study andin two of the three 24-week active-controlled studies.
The incidence with canagliflozin treatment in the two active-controlled studies was similar to comparators.
The safety and efficacy of isavuconazole for the treatment of patients withinvasive aspergillosis was evaluated in a double-blind, active-controlled clinical study in 516 patients with invasive fungal disease caused by Aspergillus species or other filamentous fungi.
The efficacy of Eperzan was evaluated in a randomised, double-blind, active-controlled 52-week study in 486 patients with mild, moderate, and severe renal impairment inadequately controlled on a current regimen of diet and exercise or other antidiabetic therapy.
In the active-controlled clinical study conducted in Europe, silodosin 8 mg once daily was shown to be non inferior to tamsulosin 0.4 mg once daily: the adjusted mean difference(95% CI) in the IPSS Total Score between treatments in the per-protocol population was 0.4 -0.4 to 1.1.