29 results
The objective for the study is to establish a proof of concept for the use of self-expandable stenting in subacute to chronic total occlusions and evaluate the safety and effectiveness of the STENTYS Coronary Stent System in the treatment of these…
The aim of this study is to determine safety, patency of placement and long term symptom-free outcome of a covered self expandable metal stent in patients with a benign CBD stricture.
The primary objective is to assess the safety and operation of the Stentys coronary stent system in patients with acute myocardial infarction compared with a balloon-expanding stent. These are the effect and safety in the short term (the procedure…
To determine the safety and effectiveness of Boston Scientific*s Everolimus-eluting coronary stent system (PROMUS Element*) for coronary revascularization in an unrestricted population compared to the Xience* Prime control.
The primary aim of the proposed study is to assess whether stenting for symptomatic vertebral artery stenosis >= 50% is feasible and safe. A secondary aim is to assess the rate of new vascular events in the territory of the vertebrobasilar…
The aim of this study is to determine safety, patency of placement and long term symptom-free outcome of a covered self expandable metal stent in patients with a benign CBD stricture.
To define indications for recently developed, but more expensive, self-expanding metal stents (SEMS) versus cheaper plastic stents in patients with primary or recurrent inoperable malignant extrahepatic common bile duct (CBD) obstruction, based on…
The primary objective of this study is to evaluate the safety and effectiveness of the Genous Bio-engineered R stentTM in conjunction with optimal statin therapy (80mg of atorvastatin), in the treatment of elective patients with up to two de novo…
Primary objective:* To evaluate the safety of BYON5667 eye drops.Secondary objective:* To evaluate the tolerability of BYON5667 eye drops.
* to evaluate the safety and tolerability of Lu AF90103 following single ascending intravenous (i.v.) doses* to investigate the pharmacokinetics (PK) of Lu AF90103 (prodrug) and Lu AF88361 (drug) in plasma and cerebrospinal fluid (CSF) following…
Primary objective:• To evaluate the safety and tolerability of single intravenous (i.v.) doses of XAB05 in healthy subjects.Secondary objective:• To characterize the plasma pharmacokinetic (PK) profile of single i.v. doses of XAB05 in healthy…
Part 1:Primary objective:• To evaluate the PK profile of a single oral dose of ESB1609 jetmilled Form A in plasma and compare this profile with the PK profile of ESB1609 monohydrate Form B with 30% SLS.• To compare the PK profile of different…
Part 1:Primary objective:• To estimate the relative bioavailability of two THB001 formulations in healthy adults.Secondary objectives:• To determine the single-dose pharmacokinetics (PK) of THB001•HCl salt and THB001 free base formulations in…
Part 1 SAD:Primary objective: To evaluate the safety and tolerability of single ascending doses of ANXV in healthy subjects.Secondary objective: To determine the PK profile of single ascending doses of ANXV in healthy subjects.Part 2 MAD:Primary…
Part 1 - Single Ascending Dose (SAD):Primary objective:• To evaluate the safety and tolerability of single oral doses of THB001 in healthy subjects.Secondary objectives:• To characterize the plasma pharmacokinetic (PK) profile of single oral doses…
Primary ObjectivesPart 1 * Single Ascending DoseThe primary objective of the single ascending dose (SAD) part of the study is to characterize the safety and tolerability of a single dose of PTC857 in healthy subjects.Part 2 * Multiple Ascending…
Primary ObjectiveTo assess the tolerability and safety of single ascending oral doses of PHA-022121 administered after a standard meal and of a single 40 mg dose under fasted conditions in healthy adult subjects.To assess the PK characteristics of…
The primary objective of this study is to confirm that the dissolution profiles of a sugar-free and sugared lozenge containing CPC/benzocaine (1.4mg/10 mg) are comparable following a single dose in healthy adult subjects.The secondary objectives of…
Primary objective:To investigate the pharmacokinetics (PK) of IZD174 in plasma and CSF of subjects with Parkinson*s Disease.Secondary objective:To investigate the pharmacodynamics (PD) of IZD174 in plasma of subjects with Parkinson*s Disease as…
Primary objective:• To investigate the effect of THB001 on the pharmacokinetics (PK) of caffeine, omeprazole and midazolam.Secondary objective:• To evaluate the safety and tolerability of THB001 co-administered with caffeine, omeprazole and…