15 results
Primary objective(s)• To assess the effects of RLX030 compared to placebo on hemodynamic variables (PCWP, CI) during the first 8 hours administered as i.v. infusion over 20 hours in subjects with Acute Hart FailureSecondary objective(s)• To assess…
Primary objective(s)To assess the effects of 24 hrs i.v. infusion of RLX030 30µg/kg/day compared to placebo on renal blood flow (RBF) as measured by PAH clearance in subjects with CHF and worsening symptoms To assess the effects of 24 hrs i.v.…
The objectives of this phase of the study are to confirm the efficacy of IV relaxin, in addition to standard therapy, in improving symptoms of heart failure, dyspnea, and in preventing intermediate term re-admission for HF or renal failure and…
To evaluate the effect of 12 weeks subcutaneous evolocumab (140 mg pre-filled pen every 2 weeks) compared to placebo on post fat load non-HDL-C levels in 30 subjects with FD, in a multicenter, randomized, placebo-controlled, double-blind, crossover…
* Primary Objective: To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in subjects with non ST elevation acute coronary syndrome (NSTE ACS) who are taking maximally tolerated statin therapy.* Secondary Objective(s): To evaluate the…
Patients with hyperlipidemie and an elevated Lp(a) will be asked to partipate in this study. This part potentially increases the risk of cardiovascular diseases. One of the reasons why Lp(a) is expected to increases this risk is that Lp(a)…
Primary Objective:To demonstrate that serelaxin is superior to placebo in reducing CV death in AHF patients during a follow-up period of 180 days.To demonstrate that serelaxin is superior to placebo in reducing worsening heart failure through Day…
To characterize the safety and tolerability of long-term administration of evolocumab in subjects with known coronary artery disease andhypercholesterolemia.
The primary outcome of the study is a 50% reduction in exacerbation rate in patients using TIS once daily (OD). Secondary outcome parameters are lung function (FEV1, FVC), QoL (QOL-B), LTRI-VAS, Leicester cough score), bacterial load in sputum and…
Primary:Assess the safety of repeat doses of serelaxin in chronic heart failureSecondary:- Assess the incidence rate of adverse events of special interest, indicative of hypersensitivity reactions- Assess the safety and tolerability of repeated…
Primary: To evaluate the effect of AMG 145 on the change in burden of coronary atherosclerosis as measured by percent atheroma volume (assessed with intravascular ultrasound, IVUS) in patients with coronary artery disease requiring angiography for a…
Primary objective:To demonstrate superiority of three dose levels of oral NNC0385-0434 versus placebo on percent change in LDL-C from baseline to week 12 in patients with established ASCVD or ASCVD risk on maximally tolerated statin dose and other…
- To evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for coronary heart disease (CHD) death, myocardial infarction (MI), or ischemic stroke, whichever occurs first, in subjects at high cardiovascular risk without…
Primary:• To evaluate the effect of inclisiran treatment on low density lipoprotein cholesterol (LDL-C) levels at Day 210 compared to Day 1 of this extension study. Secondary:• To evaluate the effects of inclisiran on the following: LDL-C levels…
PrimaryTo describe the safety and tolerability of 80 weeks of SC evolocumab when added to standard of care in pediatric subjects 10 to 17 years of age with HeFH or HoFH. Secondary Efficacy* To describe percent change and change from baseline in LDL-…