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Drug Highest PhasePhase 3 |
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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Ⅲ期临床研究
[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial evaluating 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NT-proBNP水平、生活质量评分变化。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] I. Primary Objective: To evaluate the efficacy of the experimental group (randomized to receive lyophilized recombinant human brain natriuretic peptide) compared to the placebo control group in patients with acute heart failure (AHF), using the proportion of subjects whose dyspnea improved within 24 hours as the evaluable indicator.
II. Key Secondary Objective: To evaluate the efficacy of the experimental group (randomized to receive lyophilized recombinant human brain natriuretic peptide) compared to the placebo control group in patients with AHF.
III. Secondary Objectives: 1. To evaluate the efficacy of the experimental group (randomized to receive lyophilized recombinant human brain natriuretic peptide) compared to the placebo control group in patients with AHF. 2. To explore changes in NT-proBNP levels and quality of life scores after drug administration in the experimental group (randomized to receive lyophilized recombinant human brain natriuretic peptide) and the placebo control group. 3. To evaluate the safety of all AHF patients receiving lyophilized recombinant human brain natriuretic peptide. (The safety of all AHF patients receiving placebo should also be evaluated.)
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.
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