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Clinical Trials associated with Recombinant human brain natriuretic peptide(Shijiazhuang Wotai Biological Technology Co., Ltd.)评价冻干重组人脑利钠肽治疗急性心力衰竭患者有效性和安全性的多中心、随机、双盲、安慰剂对照临床研究
[Translation] A multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of lyophilized recombinant human brain natriuretic peptide in the treatment of patients with acute heart failure
一、主要目的:以24h呼吸困难改善受试者比例为评价指标,评价试验组(随机分配接受冻干重组人脑利钠肽治疗)相比安慰剂对照组用于AHF患者疗效差异。 二、关键次要目的:评价试验组(随机分配接受冻干重组人脑利钠肽治疗)相比安慰剂对照组用于AHF患者的疗效。
三、次要目的:
1、 评价试验组(随机分配接受冻干重组人脑利钠肽治疗)相比安慰剂对照组用于AHF患者的疗效。 2、探索试验组(随机分配接受冻干重组人脑利钠肽治疗)、安慰剂对照组给药后利钠肽水平变化。
3、评价所有接受冻干重组人脑利钠肽治疗的AHF患者的安全性。 评价所有接受安慰剂治疗的AHF患者的安全性。
[Translation] 1. Main purpose: To evaluate the difference in efficacy of the trial group (randomly assigned to receive lyophilized recombinant human brain natriuretic peptide) compared with the placebo control group in AHF patients, using the proportion of subjects with improved dyspnea within 24 hours as the evaluation index. 2. Key secondary purpose: To evaluate the efficacy of the trial group (randomly assigned to receive lyophilized recombinant human brain natriuretic peptide) compared with the placebo control group in AHF patients.
3. Secondary purpose:
1. To evaluate the efficacy of the trial group (randomly assigned to receive lyophilized recombinant human brain natriuretic peptide) compared with the placebo control group in AHF patients. 2. To explore the changes in natriuretic peptide levels after administration in the trial group (randomly assigned to receive lyophilized recombinant human brain natriuretic peptide) and the placebo control group.
3. To evaluate the safety of all AHF patients treated with lyophilized recombinant human brain natriuretic peptide. To evaluate the safety of all AHF patients treated with placebo.
评价不同剂量冻干重组人脑利钠肽在急性失代偿性心力衰竭(ADHF)患者人群中的安全性、药代动力学特征以及初步疗效的单中心、随机、双盲、安慰剂对照的 I期研究
[Translation] A single-center, randomized, double-blind, placebo-controlled phase I study to evaluate the safety, pharmacokinetic characteristics and preliminary efficacy of different doses of lyophilized recombinant human brain natriuretic peptide in patients with acute decompensated heart failure (ADHF)
探索冻干重组人脑利钠肽在休息或轻微活动时呼吸困难的急性失代偿性心力衰竭(ADHF)患者中的安全性和耐受性。
[Translation] To investigate the safety and tolerability of lyophilized recombinant human brain natriuretic peptide in patients with acute decompensated heart failure (ADHF) who have dyspnea at rest or with minimal activity.
100 Clinical Results associated with Recombinant human brain natriuretic peptide(Shijiazhuang Wotai Biological Technology Co., Ltd.)
100 Translational Medicine associated with Recombinant human brain natriuretic peptide(Shijiazhuang Wotai Biological Technology Co., Ltd.)
100 Patents (Medical) associated with Recombinant human brain natriuretic peptide(Shijiazhuang Wotai Biological Technology Co., Ltd.)
100 Deals associated with Recombinant human brain natriuretic peptide(Shijiazhuang Wotai Biological Technology Co., Ltd.)