Study-specific information for healthcare providers
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The TRAVERSE study is designed to evaluate long-term testosterone replacement therapy with AndroGel 1.62% compared to placebo on major adverse cardiovascular events in symptomatic hypogonadal men ages 45-80 with a history of coronary artery disease, cerebrovascular disease, and peripheral vascular disease. Other safety and efficacy endpoints will also be evaluated. Qualified patients will be enrolled for up to 5 years. It is requested that serum testosterone, PSA, and Hct results remain blinded to the patient so treatment assignments cannot be “guessed”. Testosterone, PSA, and Hct will be obtained regularly in the study during the patient’s participation. Patients will still be encouraged to follow-up with their regular doctors visits while enrolled. For more information please visit clincialtrials.gov
The trial is a multi-center, randomized, double-blind, active (omalizumab) and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) in adolescents and adults inadequately controlled with H1-antihistamines.
Ligelizumab is a humanized IgG-type monoclonal antibody that binds to IgE with higher affinity than omalizumab. Eligible patients are those aged ≥ 12 years and remain symptomatic despite the use of anti-histamines. However, patients with any prior exposure to omalizumab or ligelizumab are not eligible. For more information visit clinicaltrials.gov
Safety and efficacy of nemolizumab in subjects with moderate-to-severe atopic dermatits. To read more about this trial, please visit clinicaltrials.gov
A safety and efficacy study of relamorelin in diabetic gastroparesis. Relamorelin is a novel small synthetic peptide pentapeptide that acts as a ghrelin receptor agonist. It binds to the GHS-1a receptor with ∼ 3-fold more potency than natural ghrelin and is 6-fold more potent than h-ghrelin in activating the GHS-1a receptor.
Eligible patients are those with Type 1 or 2 diabetes mellitus and experiencing symptoms of gastroparesis. Patients will be randomized 1:1 to blinded treatment with relamorelin 10µg or placebo. Their participation will last approximately 16 weeks with the possibility to continue in an additional 46-week relamorelin trial once completed. For more information, please visit clinicaltrials.gov
A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects with Asthma. For more information please visit clinicaltrials.gov.
Pharmacodynamic bronchodilation bioequivalence study of albuterol sulfate HFA MDI 90 mcg/inhalation in asthma patients
This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study to compare 2 dose levels of BDA MDI (PT027) to its components BD MDI (PT008) and AS MDI (PT007) on improvement in lung function and asthma symptoms after 12 weeks of treatment in adult, adolescent, and child subjects with symptomatic asthma currently being treated with a short/rapid-acting β2-adrenoreceptor agonist (SABA; eg, Ventolin) as needed alone or with low-dose inhaled corticosteroid (ICS) maintenance therapy plus SABA as needed. For more information please visit clinicaltrials.gov.
This study aims to evaluate the non-inferiority of abaloparatide-sMTS 300 μg compared to abaloparatide-SC 80 μg based on lumbar spine bone mineral density (BMD) at 12 months and to evaluate the safety and tolerability of abaloparatide-sMTS in the treatment of postmenopausal women with osteoporosis. For more information please visit clinicaltrials.gov.
This study is for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman’s last period. Hot flashes can interrupt a woman’s daily life.
The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) The study will compare fezolinetant and placebo after 4 and 12 weeks of dosing. The study will see if fezolinetant reduces the number of hot flashes. And the study will see if fezolinetant reduces the severity of the hot flashes. For more information please visit clinicaltrials.gov.
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