scholarly journals The Phase III, double-blind, parallel-group controlled study of amlodipine 10 mg once daily in Japanese patients with essential hypertension who insufficiently responded to amlodipine 5 mg once daily

2009 ◽  
Vol 23 (8) ◽  
pp. 521-529 ◽  
Author(s):  
T Fujiwara ◽  
Y Ii ◽  
J Hatsuzawa ◽  
H Murase ◽  
T Watanabe ◽  
...  
Keyword(s):  
Essential Hypertension ◽  
Japanese Patients ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind ◽  
Once Daily ◽  
Parallel Group

scholarly journals Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine

2011 ◽  
Vol 198 (1) ◽  
pp. 51-58 ◽  
Author(s):  
Michael D. Lesem ◽  
Tram K. Tran-Johnson ◽  
Robert A. Riesenberg ◽  
David Feifel ◽  
Michael H. Allen ◽  
...  
Keyword(s):  
Acute Treatment ◽  
Phase Iii ◽  
Controlled Study ◽  
Primary Efficacy ◽  
Double Blind ◽  
End Point ◽  
Syndrome Scale ◽  
Parallel Group ◽  
Negative Syndrome ◽  
Clinical Global Impression Improvement

BackgroundThere is a need for a rapid-acting, non-injection, acute treatment for agitation.AimsTo evaluate inhaled loxapine for acute treatment of agitation in schizophrenia.MethodThis phase III, randomised, double-blind, placebo-controlled, parallel-group study (ClinicalTrials.gov number NCT00628589) enrolled 344 individuals who received one, two or three doses of inhaled loxapine (5 or 10 mg) or a placebo. Lorazepam rescue was permitted after dose two. The primary efficacy end-point was change from baseline in Positive and Negative Syndrome Scale–Excited Component (PANSS–EC) 2 h after dose one. The key secondary end-point was Clinical Global Impression–Improvement scale (CGI–I) score 2 h after dose one.ResultsInhaled loxapine (5 and 10 mg) significantly reduced agitation compared with placebo as assessed by primary and key secondary end-points. Reduced PANSS–EC score was evident 10 min after dose one with both 5 and 10mg doses. Inhaled loxapine was well tolerated, and the most common adverse events were known effects of loxapine or minor oral effects common with inhaled medications.ConclusionsInhaled loxapine provided a rapid, well-tolerated acute treatment for agitation in people with schizophrenia.

Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study

2014 ◽  
Vol 30 (10) ◽  
pp. 2069-2083 ◽  
Author(s):  
Lesley M. Arnold ◽  
Pierre Arsenault ◽  
Cynthia Huffman ◽  
Jeffrey L. Patrick ◽  
Michael Messig ◽  
...  
Keyword(s):  
Controlled Release ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind ◽  
Once Daily

scholarly journals Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase III randomised, double-blind, placebo-controlled trial (RAJ4) in Japan

2019 ◽  
Vol 78 (10) ◽  
pp. 1305-1319 ◽  
Author(s):  
Tsutomu Takeuchi ◽  
Yoshiya Tanaka ◽  
Sakae Tanaka ◽  
Atsushi Kawakami ◽  
Manabu Iwasaki ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Japanese Patients ◽  
Janus Kinase ◽  
Phase Iii ◽  
Tolerability Profile ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acr20 Response ◽  
Once Daily

ObjectiveTo evaluate the efficacy and safety of the oral Janus kinase (JAK) inhibitor peficitinib versus placebo in Japanese patients with rheumatoid arthritis (RA).MethodsIn this multicentre, double-blind, parallel-group, placebo-controlled phase III study, patients with RA and inadequate response to methotrexate (MTX) were randomised 1:1:1 to placebo, peficitinib 100 mg once daily or peficitinib 150 mg once daily with MTX for 52 weeks. Based on baseline randomisation, at week 12, non-responders receiving placebo were switched to peficitinib until the end of treatment; the remaining patients were switched to peficitinib at week 28. Primary efficacy variables were American College of Rheumatology (ACR)20 response rate at week 12/early termination (ET) and change from baseline in van der Heijde-modified total Sharp score (mTSS) at week 28/ET.Results519 patients were randomised and treated. Significantly more (p<0.001) peficitinib (58.6%, 100 mg; 64.4%, 150 mg) than placebo (21.8%) recipients achieved ACR20 response at week 12/ET. Significantly lower (p<0.001) mean changes from baseline in mTSS at week 28/ET occurred in peficitinib (1.62, 100 mg; 1.03, 150 mg) than placebo (3.37) recipients. Peficitinib was associated with haematological and biochemical parameter changes, and increased incidence of serious infections and herpes zoster-related disease. One death from suicide occurred in a patient in the placebo group after switching to peficitinib 100 mg.ConclusionsIn Japanese patients with RA and inadequate response to MTX, peficitinib demonstrated significant superiority versus placebo in reducing RA symptoms and suppressing joint destruction. Peficitinib had an acceptable safety and tolerability profile, with no new safety signals compared with other JAK inhibitors.Trial registration numberNCT02305849.

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