[Translation] A multicenter, randomized, double-blind, positive-controlled clinical study to evaluate the pharmacodynamic effect, safety, tolerability and pharmacokinetics of multiple doses of DDCI-01 capsules in patients with pulmonary arterial hypertension
主要目的:
1.评价DDCI-01胶囊不同剂量之间以及与阳性对照药相比较,对肺动脉高压患者血流动力学参数的影响。
2.评价肺动脉高压患者口服不同剂量DDCI-01胶囊后的安全性和耐受性。
次要目的:
1.评价DDCI-01胶囊对肺动脉高压患者生物标志物(BNP、NT-proBNP)的影响。
2.评价DDCI-01胶囊对肺动脉高压患者6分钟步行距离与活动后Borg呼吸困难分级的影响。
3.评价DDCI-01胶囊对肺动脉高压患者生活质量的影响。
4.评价DDCI-01胶囊在肺动脉高压患者中的药代动力学特征。
[Translation] Main objectives:
1. To evaluate the effects of different doses of DDCI-01 capsules and compared with positive control drugs on hemodynamic parameters in patients with pulmonary hypertension.
2. To evaluate the safety and tolerability of different doses of DDCI-01 capsules in patients with pulmonary hypertension.
Secondary objectives:
1. To evaluate the effects of DDCI-01 capsules on biomarkers (BNP, NT-proBNP) in patients with pulmonary hypertension.
2. To evaluate the effects of DDCI-01 capsules on 6-minute walking distance and Borg dyspnea grade after activity in patients with pulmonary hypertension.
3. To evaluate the effects of DDCI-01 capsules on the quality of life of patients with pulmonary hypertension.
4. To evaluate the pharmacokinetic characteristics of DDCI-01 capsules in patients with pulmonary hypertension.