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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date10 Apr 2008 |
瑞加诺生注射液用于负荷超声心动图试验诊断冠心病的多中心、随机、自身对照、阳性药对照的Ⅲ期临床研究
[Translation] A multicenter, randomized, self-controlled, positive drug-controlled phase III clinical study of Reganosane injection for the diagnosis of coronary heart disease in stress echocardiography
1、主要目的:以冠状动脉造影为金标准,评价与腺苷注射液相比,瑞加诺生注射液作为超声心动图负荷药物对于冠心病的诊断效能。
2、次要目的:评价与腺苷注射液相比,瑞加诺生注射液作为超声心动图负荷药物的安全性。
[Translation] 1. Primary purpose: Using coronary angiography as the gold standard, evaluate the diagnostic efficacy of Reganosane injection as an echocardiographic stress drug for coronary heart disease compared with adenosine injection.
2. Secondary purpose: Evaluate the safety of Reganosane injection as an echocardiographic stress drug compared with adenosine injection.
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