22 results
The primary objective of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with PAH. This will be assessed by time…
The primary objective is to test the hypothesis that once daily tadalafil administered orally for 48 weeks lessens the decline in ambulatory ability as measured by the 6MWD compared to placebo in boys with Duchenne muscular dystrophy (DMD). Two…
Objective of the study is to verify whether the movement pattern after anterior cervical discectomy normalises, in case of implantation of a cervical disc prosthesis.
Primary ObjectiveTo investigate the possible efficacy of combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in increasing sexual satisfaction during sexual activity in the domestic setting in healthy female subjects with…
There is no formal research hypothesis for this study. The purpose is to evaluate the effects of dapagliflozin on kidney function (GFR) and the changes from baseline in the ambulatory Blood Pressure. The effects of dapagliflozin on red cell mass and…
The aim of the study is to investigate effects of dapagliflozin on potential mechanisms explaining improved insulin sensitivity in skeletal muscles.
The primary objective is to assess the proportion of patients in each treatment arm with a satisfactory clinical response as defined by a composite primary endpoint at Week 24.The secondary objective is to demonstrate safety and clinical effect at…
The aim of the proposed study is to investigate the efficacy and safety of dapagliflozin in patients with an established diagnosis of HFrEF (with or without T2D) where the prevalence and unmet needs for reducing CV mortality and heart failure events…
ObjectivesPrimary objectiveThe primary objective is to determine the effect of dapagliflozin relative to placebo oncardiovascular outcomes when added to current background therapy in patients with type 2diabetes mellitus (T2DM) with either…
To explore the inflammatory changes of dapagliflozin compared with placebo on postprandial lipemia and postprandial leukocyte activation, oxidative stress and endothelial function in men with type 2 diabetes mellitus using insulin.
Primary objective: to investigate the effect of treatment with the SGLT-2 inhibitor dapagliflozin on the awareness of and counterregulatory hormone responses to hypoglycemia in people with type 1 diabetes and impaired awareness of hypoglycemia.…
Primary objective:To investigate the separate and combined actions of the SGLT2 inhibitor dapagliflozin and GLP-1 receptor agonist exenatide on activity in central reward and satiety circuits in response to food related stimuli in obese patients…
The main objective of the study is to determine the albuminuria lowering effect of the GLP1-RA exenetide, SGLT-2 inhibitor dapagliflozin and their combination in patients with type 2 diabetes and micro- or macroalbuminuria.Secondary objectives are…
Primary: * To assess the change baseline in 24-hr proteinuria with dapagliflozin for six weeks relative to placebo treatment in patients with non-diabetic kidney disease and proteinuria > 500 mg/day on stable ACEi or ARB treatment. Secondary…
To gain more knowledge about the effects of SGLT2 inhibition on renal hemodynamics and the underlying mechanisms.
The purpose of this study is to investigate the effectiveness and safety of dapagliflozin for glucose control in patients with exacerbation COPD on high dose glucocorticoids.Effectiveness of glucose control in clinical practice is measured by the…
Primary Objectives:* For the European Union (EU) regulatory assessment, the primary objective of Period 1 is to evaluate theefficacy of tadalafil compared with placebo, as measured by time to clinical worsening (CW) in pediatricPAH patients through…
Primary Objective The primary objective of this study is to compare the change from baseline in HbA1c after 24 weeks of double blinded treatment with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin.…
Primary:To investigate change in 24-hr sodium excretion during dapagliflozintreatment between Baseline (average of Days *3 to *1) and averageof Days 2 to 4 within each study group in patients withtype 2 diabetes mellitus (T2DM) with preserved or…
To assess the albuminuria lowering effects of dapagliflozin in subjects with and without diabetes or hypertension and persistent elevated albuminuria.