13 results
This trial will determine the relative incidence of CV outcomes compared to placebo forthe TZD class as a whole, rosiglitazone (RSG), and pioglitazone (PIO) when added to thetherapeutic regimen of a person with type 2 diabetes who has additional…
To estimate the effect of rosiglitazone compared to placebo on ischemia-reperfusion injury as assessed by annexin A5 scintigraphy in the human forearm in subjects with the metabolic syndrome.
Primary objective : Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients (no antidiabetic drug treatment in the last 6 months), with type 2 diabetes mellitus and dyslipidemia, to show that : - the efficacy of a…
The primary aim of this study will be to determine the effect of rosiglitazone on intima media thickness and calcification in patients with stage 4 and 5 CKD. The secondary end points are the effects on pulse wave velocity, blood pressure, the lipid…
MAIN OBJECTIVEDose escalation phase :- To determine the MTD and/or RDE of alpelisib (BYL719) in combination with everolimus, and the MTD and/or RDE of alpelisib in combination with everolimus and exemestaneDose expansion part:- To describe safety…
Primary: The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs progression free survival (PFS) compared to treatment with placebo in combination with fulvestrant based on local radiological…
Primary objective: The primary purpose of the research is to determine the difference in pain experience during rest, measured by means of an 11-point Numerical Rating Scale (NRS), between peroperatieve Local infiltration with Analgesics (LIA) vs.…
The study has been designed to demonstrate whether alpelisib in combination with trastuzumab (and fulvestrant in case of HR+) shows a higher clinical benefit compared with trastuzumab in combination with chemotherapy.Some of the secondary objectives…
In the current phase 2 study we will investigate the efficacy of the combination of fulvestrant and alpelisib directly after progression on 1st or 2nd line therapy with fulvestrant with or without a CDK 4/6 inhibitor in patients with HR+HER2-…
Primary objective:* To demonstrate the efficacy of alpelisib as measured by the proportion of participants randomized to alpelisib with a response at Week 24 in at least one of the following groups:* Group 1 (>= 18 yr-old)* Group 2 (6 - 17 yr…
The purpose of the study is to determine whether treatment with alpelisib in combination with olaparib can delay the time to cancer progression compared to standard-of-care chemotherapy in participants with your type of ovarian cancer known as…
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)
Primary ObjectivesSafety run-in Part 1:To confirm the recommended dose of alpelisib in combination with trastuzumab and pertuzumab for Part 2.Double-blind, randomized, placebo-controlled Part 2:To determine whether treatment with alpelisib in…